Trial Outcomes & Findings for Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources (NCT NCT01956032)
NCT ID: NCT01956032
Last Updated: 2016-02-23
Results Overview
Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.
COMPLETED
15 participants
From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
2016-02-23
Participant Flow
Participant milestones
| Measure |
Participants With Parkinson's Disease
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources
Baseline characteristics by cohort
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Age, Continuous
|
65.5 Years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using full analysis set (FAS), defined as all participants that started Duodopa titration.
Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator: All Types (N=12)
|
29.1 Minutes
Interval 3.0 to 39.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator: TM (N=12)
|
22.2 Minutes
Interval 3.0 to 39.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator: Telephone (N=1)
|
30.0 Minutes
Interval 30.0 to 30.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator: Home Visit (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator: Other (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + DNS: All Types
|
317.4 Minutes
Interval 130.0 to 558.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + DNS: TM
|
22.8 Minutes
Interval 10.0 to 97.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + DNS: Telephone (N=8)
|
15.9 Minutes
Interval 1.0 to 46.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + DNS: Home Visit
|
280.8 Minutes
Interval 75.0 to 437.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + DNS: Other (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator + DNS: All Types
|
45.0 Minutes
Interval 22.0 to 77.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator + DNS: TM
|
42.0 Minutes
Interval 22.0 to 77.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator + DNS: Telephone (N=1)
|
7.2 Minutes
Interval 7.2 to 7.2
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator + DNS: Home Visit (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + Investigator + DNS: Other (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + TM Technician: All Types
|
100.2 Minutes
Interval 60.0 to 240.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + TM Technician: TM (N=1)
|
1.8 Minutes
Interval 1.8 to 1.8
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + TM Technician: Telephone (N=1)
|
4.2 Minutes
Interval 4.2 to 4.2
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + TM Technician: Home Visit
|
100.2 Minutes
Interval 60.0 to 240.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Participant + TM Technician: Other (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total DNS: All Types
|
349.2 Minutes
Interval 166.0 to 603.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total DNS: TM
|
78.6 Minutes
Interval 41.0 to 132.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total DNS: Telephone (N=8)
|
15.9 Minutes
Interval 1.0 to 50.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total DNS: Home Visit
|
280.8 Minutes
Interval 75.0 to 437.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total DNS: Other (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total Investigator: All Types
|
73.8 Minutes
Interval 29.0 to 112.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total Investigator: TM
|
57.0 Minutes
Interval 29.0 to 112.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total Investigator: Telephone (N=1)
|
37.2 Minutes
Interval 37.2 to 37.2
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total Investigator: Home Visit (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total Investigator: Other (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total Participant: All Types
|
532.8 Minutes
Interval 251.0 to 878.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total participant: TM
|
100.2 Minutes
Interval 43.0 to 171.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total Participant: Telephone (N=8)
|
15.9 Minutes
Interval 5.0 to 80.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total Participant: Home Visit
|
345.0 Minutes
Interval 165.0 to 677.0
|
|
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Total Participant: Other (N=0)
|
NA Minutes
Data were not available due to zero participants analyzed.
|
PRIMARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Median Number of Contacts
Participant + TM Technician: Other
|
0.0 Number of contacts
Interval 0.0 to 0.0
|
|
Median Number of Contacts
Total Contact With Participant: All Types
|
19.0 Number of contacts
Interval 12.0 to 37.0
|
|
Median Number of Contacts
Total Contact With Participant: TM
|
13.0 Number of contacts
Interval 7.0 to 23.0
|
|
Median Number of Contacts
Total Contact With Participant: Telephone
|
1.0 Number of contacts
Interval 0.0 to 11.0
|
|
Median Number of Contacts
Total Contact With Participant: Home Visit
|
5.0 Number of contacts
Interval 3.0 to 6.0
|
|
Median Number of Contacts
Total Contact With Participant: Other
|
0.0 Number of contacts
Interval 0.0 to 0.0
|
|
Median Number of Contacts
Participant + Investigator: All Types
|
3.0 Number of contacts
Interval 0.0 to 5.0
|
|
Median Number of Contacts
Participant + Investigator: TM
|
2.0 Number of contacts
Interval 0.0 to 5.0
|
|
Median Number of Contacts
Participant + Investigator: Telephone
|
0.0 Number of contacts
Interval 0.0 to 3.0
|
|
Median Number of Contacts
Participant + Investigator: Home Visit
|
0.0 Number of contacts
Interval 0.0 to 0.0
|
|
Median Number of Contacts
Participant + Investigator: Other
|
0.0 Number of contacts
Interval 0.0 to 0.0
|
|
Median Number of Contacts
Participant + DNS: All Types
|
9.0 Number of contacts
Interval 5.0 to 22.0
|
|
Median Number of Contacts
Participant + DNS: TM
|
5.0 Number of contacts
Interval 2.0 to 12.0
|
|
Median Number of Contacts
Participant + DNS: Telephone
|
1.0 Number of contacts
Interval 0.0 to 7.0
|
|
Median Number of Contacts
Participant + DNS: Home Visit
|
3.0 Number of contacts
Interval 1.0 to 4.0
|
|
Median Number of Contacts
Participant + DNS: Other
|
0.0 Number of contacts
Interval 0.0 to 0.0
|
|
Median Number of Contacts
Participant + Investigator + DNS: All Types
|
5.0 Number of contacts
Interval 2.0 to 11.0
|
|
Median Number of Contacts
Participant + Investigator + DNS: TM
|
5.0 Number of contacts
Interval 2.0 to 11.0
|
|
Median Number of Contacts
Participant + Investigator + DNS: Telephone
|
0.0 Number of contacts
Interval 0.0 to 1.0
|
|
Median Number of Contacts
Participant + Investigator + DNS: Home Visit
|
0.0 Number of contacts
Interval 0.0 to 0.0
|
|
Median Number of Contacts
Participant + Investigator + DNS: Other
|
0.0 Number of contacts
Interval 0.0 to 0.0
|
|
Median Number of Contacts
Participant + TM Technician: All Types
|
2.0 Number of contacts
Interval 1.0 to 3.0
|
|
Median Number of Contacts
Participant + TM Technician: TM
|
0.0 Number of contacts
Interval 0.0 to 1.0
|
|
Median Number of Contacts
Participant + TM Technician: Telephone
|
0.0 Number of contacts
Interval 0.0 to 1.0
|
|
Median Number of Contacts
Participant + TM Technician: Home Visit
|
2.0 Number of contacts
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator's decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Median Total Time for Titration
|
4093.2 Minutes
Interval 2850.0 to 19925.0
|
SECONDARY outcome
Timeframe: From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
Participant's daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant's daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant's total free time was calculated as the sum of participant's daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Median Total Free Time of Participant
|
3865.2 Minutes
Interval 2458.0 to 13659.0
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Percentage of Participants Who Experienced Technical Events
Any Technical Event
|
73.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type A: Failure to Answer Video Call
|
13.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type A: Other
|
6.7 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type B: Intentional Failure to Answer Video Call
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type B: Other
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type C: Mechanical
|
13.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type C: Electrical
|
20.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type C: Other
|
33.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type D: Failure to Establish Connection
|
40.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type D: Interruptions
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type D: Transmission Quality
|
13.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type D: Sound Quality
|
33.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type D: Image Quality
|
6.7 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events
Type D: Other
|
6.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Incidence of Technical Events Experienced by Participants
Any Technical Event (N=11)
|
100.0 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type A: Failure to Answer Video Call (AVC) (N=2)
|
5.9 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type A: Other (N=1)
|
2.9 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type B: Intentional Failure to AVC (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants
Type B: Other (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants
Type C: Mechanical (N=2)
|
8.8 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type C: Electrical (N=3)
|
14.7 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type C: Other (N=5)
|
14.7 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type D: Failure to Establish Connection (N=6)
|
32.4 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type D: Interruptions (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants
Type D: Transmission Quality (N=2)
|
5.9 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type D: Sound Quality (N=5)
|
17.6 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type D: Image Quality (N=1)
|
2.9 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants
Type D: Other (N=1)
|
2.9 Percentage of technical events
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Percentage of Participants With Consequences
Any Consequence
|
73.3 Percentage of participants
|
|
Percentage of Participants With Consequences
Contact Delay: Type A
|
6.7 Percentage of participants
|
|
Percentage of Participants With Consequences
Contact Delay: Type B
|
0.0 Percentage of participants
|
|
Percentage of Participants With Consequences
Contact Delay: Type C
|
20.0 Percentage of participants
|
|
Percentage of Participants With Consequences
Contact Delay: Type D
|
20.0 Percentage of participants
|
|
Percentage of Participants With Consequences
Re-establishment of Connection: Type A
|
6.7 Percentage of participants
|
|
Percentage of Participants With Consequences
Re-establishment of Connection: Type B
|
0.0 Percentage of participants
|
|
Percentage of Participants With Consequences
Re-establishment of Connection: Type C
|
26.7 Percentage of participants
|
|
Percentage of Participants With Consequences
Re-establishment of Connection: Type D
|
33.3 Percentage of participants
|
|
Percentage of Participants With Consequences
TM-call Replaced by Telephone Call: Type A
|
20.0 Percentage of participants
|
|
Percentage of Participants With Consequences
TM-call Replaced by Telephone Call: Type B
|
0.0 Percentage of participants
|
|
Percentage of Participants With Consequences
TM-call Replaced by Telephone Call: Type C
|
26.7 Percentage of participants
|
|
Percentage of Participants With Consequences
TM-call Replaced by Telephone Call: Type D
|
46.7 Percentage of participants
|
|
Percentage of Participants With Consequences
Failed Scheduled Contact: Type A
|
0.0 Percentage of participants
|
|
Percentage of Participants With Consequences
Failed Scheduled Contact: Type B
|
0.0 Percentage of participants
|
|
Percentage of Participants With Consequences
Failed Scheduled Contact: Type C
|
13.3 Percentage of participants
|
|
Percentage of Participants With Consequences
Failed Scheduled Contact: Type D
|
0.0 Percentage of participants
|
|
Percentage of Participants With Consequences
Other Consequence: Type A
|
0.0 Percentage of participants
|
|
Percentage of Participants With Consequences
Other Consequence: Type B
|
0.0 Percentage of participants
|
|
Percentage of Participants With Consequences
Other Consequence: Type C
|
13.3 Percentage of participants
|
|
Percentage of Participants With Consequences
Other Consequence: Type D
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Incidence of Consequences Due to Technical Events
Any Consequence (N=11)
|
100.0 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
Contact Delay: Type A (N=1)
|
2.3 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
Contact Delay: Type B (N=0)
|
NA Percentage of consequences
Data were not available due to zero participants analyzed.
|
|
Incidence of Consequences Due to Technical Events
Contact Delay: Type C (N=3)
|
7.0 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
Contact Delay: Type D (N=3)
|
11.6 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
Re-establishment of Connection: Type A (N=1)
|
2.3 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
Re-establishment of Connection: Type B (N=0)
|
NA Percentage of consequences
Data were not available due to zero participants analyzed.
|
|
Incidence of Consequences Due to Technical Events
Re-establishment of Connection: Type C (N=4)
|
9.3 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
Re-establishment of Connection: Type D (N=5)
|
18.6 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
TM-call Replaced by Telephone Call: Type A (N=3)
|
7.0 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
TM-call Replaced by Telephone Call: Type B (N=0)
|
NA Percentage of consequences
Data were not available due to zero participants analyzed.
|
|
Incidence of Consequences Due to Technical Events
TM-call Replaced by Telephone Call: Type C (N=4)
|
11.6 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
TM-call Replaced by Telephone Call: Type D (N=7)
|
23.3 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
Failed Scheduled Contact: Type A (N=0)
|
NA Percentage of consequences
Data were not available due to zero participants analyzed.
|
|
Incidence of Consequences Due to Technical Events
Failed Scheduled Contact: Type B (N=0)
|
NA Percentage of consequences
Data were not available due to zero participants analyzed.
|
|
Incidence of Consequences Due to Technical Events
Failed Scheduled Contact: Type C (N=2)
|
4.7 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
Failed Scheduled Contact: Type D (N=0)
|
NA Percentage of consequences
Data were not available due to zero participants analyzed.
|
|
Incidence of Consequences Due to Technical Events
Other Consequence: Type A (N=0)
|
NA Percentage of consequences
Data were not available due to zero participants analyzed.
|
|
Incidence of Consequences Due to Technical Events
Other Consequence: Type B (N=0)
|
NA Percentage of consequences
Data were not available due to zero participants analyzed.
|
|
Incidence of Consequences Due to Technical Events
Other Consequence: Type C (N=2)
|
7.0 Percentage of consequences
|
|
Incidence of Consequences Due to Technical Events
Other Consequence: Type D (N=0)
|
NA Percentage of consequences
Data were not available due to zero participants analyzed.
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Any Technical Event
|
73.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type A: Contact Delay
|
6.7 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type A: Re-establishment of Connection
|
6.7 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type A: TM-call Replaced by Telephone Call
|
20.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type A: Failed Scheduled Contact Failure
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type A: Other Consequence
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type B: Contact Delay
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type B: Re-establishment of Connection
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type B: TM-call Replaced by Telephone Call
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type B: Failed Scheduled Contact Failure
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type B: Other Consequence
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type C: Contact Delay
|
20.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type C: Re-establishment of Connection
|
26.7 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type C: TM-call Replaced by Telephone Call
|
26.7 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type C: Failed Scheduled Contact Failure
|
13.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type C: Other Consequence
|
13.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type D: Contact Delay
|
20.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type D: Re-establishment of Connection
|
33.3 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type D: TM-call Replaced by Telephone Call
|
46.7 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type D: Failed Scheduled Contact Failure
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Type D: Other Consequence
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Any Technical Event (N=11)
|
100.0 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type A: Contact Delay (N=1)
|
2.9 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type A: Re-establishment of Connection (N=1)
|
2.9 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type A: TM-call Replaced by Telephone Call (N=3)
|
8.8 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type A: Failed Scheduled Contact Failure (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type A: Other Consequence (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type B: Contact Delay (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type B: Re-establishment of Connection (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type B: TM-call Replaced by Telephone Call (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type B: Failed Scheduled Contact Failure (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type B: Other Consequence (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type C: Contact Delay (N=3)
|
8.8 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type C: Re-establishment of Connection (N=4)
|
11.8 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type C: TM-call Replaced by Telephone Call (N=4)
|
14.7 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type C: Failed Scheduled Contact Failure (N=2)
|
5.9 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type C: Other Consequence (N=2)
|
8.8 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type D: Contact Delay (N=3)
|
14.7 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type D: Re-establishment of Connection (N=5)
|
23.5 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type D: TM-call Replaced by Telephone Call (N=7)
|
29.4 Percentage of technical events
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type D: Failed Scheduled Contact Failure (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
|
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Type D: Other Consequence (N=0)
|
NA Percentage of technical events
Data were not available due to zero participants analyzed.
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
Scale 1 (Very Dissatisfied)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
Scale 4
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
Scale 5
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
Scale 6
|
28.6 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
Scale 7 (Very Satisfied)
|
57.1 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?
|
92.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
Scale 5
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
Scale 6
|
35.7 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
Scale 7 (Very Easy)
|
50.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
Scale 1 (Very Hard)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
Scale 4
|
7.1 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
Scale 1 (Very Dissatisfied)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
Scale 4
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
Scale 5
|
14.3 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
Scale 6
|
28.6 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
Scale 7 (Very Satisfied)
|
57.1 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
Scale 1 (Very Dissatisfied)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
Scale 4
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
Scale 5
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
Scale 6
|
35.7 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
Scale 7 (Very Satisfied)
|
57.1 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
Scale 1 (Very Dissatisfied)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
Scale 4
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
Scale 5
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
Scale 6
|
21.4 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
Scale 7 (Very Satisfied)
|
71.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
Scale 1 (Very Dissatisfied)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
Scale 4
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
Scale 5
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
Scale 6
|
28.6 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
Scale 7 (Very Satisfied)
|
64.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
Scale 1 (Very Dissatisfied)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
Scale 3
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
Scale 4
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
Scale 5
|
14.3 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
Scale 6
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
Scale 7 (Very Satisfied)
|
78.6 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician's visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
Scale 1 (Very Dissatisfied)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
Scale 3
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
Scale 4
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
Scale 5
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
Scale 6
|
21.4 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
Scale 7 (Very Satisfied)
|
64.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
Scale 1 (Very Unconfident)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
Scale 4
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
Scale 5
|
14.3 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
Scale 6
|
42.9 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
Scale 7 (Very Confident)
|
42.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure' and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
Scale 1 (Very Unsecure)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
Scale 4
|
7.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
Scale 5
|
14.3 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
Scale 6
|
14.3 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
Scale 7 (Very Secure)
|
64.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?
|
92.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant's home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=9 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
Scale 1 (Very Dissatisfied)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
Scale 4
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
Scale 5
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
Scale 6
|
11.1 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
Scale 7 (Very Satisfied)
|
88.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 14 (Where you able to perform daily activities during the titration period?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=9 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?
|
88.9 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=6 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
Scale 1 (Very Unconfident)
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
Scale 2
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
Scale 3
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
Scale 4
|
0.0 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
Scale 5
|
16.7 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
Scale 6
|
16.7 Percentage of participants
|
|
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
Scale 7 (Very Confident)
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=9 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
Investigator Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
Investigator Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
Investigator Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
Investigator Experience: Scale 4
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
Investigator Experience: Scale 5
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
Investigator Experience: Scale 6
|
53.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
Investigator Experience: Scale 7-Very Satisfied
|
40.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
DNS Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
DNS Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
DNS Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
DNS Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
DNS Experience: Scale 5
|
20.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
DNS Experience: Scale 6
|
40.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
DNS Experience: Scale 7-Very Satisfied
|
40.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
DNS Experience: Scale 4
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
Investigator Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
Investigator Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
Investigator Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
Investigator Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
Investigator Experience: Scale 5
|
13.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
Investigator Experience: Scale 6
|
46.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
Investigator Experience: Scale 7--Very Satisfied
|
40.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
DNS Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
DNS Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
DNS Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
DNS Experience: Scale 5
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
DNS Experience: Scale 6
|
46.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
DNS Experience: Scale 7--Very Satisfied
|
46.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
Investigator Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
Investigator Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
Investigator Experience: Scale 3
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
Investigator Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
Investigator Experience: Scale 5
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
Investigator Experience: Scale 6
|
46.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
Investigator Experience: Scale 7-Very Satisfied
|
40.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
DNS Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
DNS Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
DNS Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
DNS Experience: Scale 4
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
DNS Experience: Scale 5
|
13.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
DNS Experience: Scale 6
|
40.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
DNS Experience: Scale 7-Very Satisfied
|
40.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
Investigator Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
Investigator Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
Investigator Experience: Scale 3
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
Investigator Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
Investigator Experience: Scale 5
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
Investigator Experience: Scale 6
|
26.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
Investigator Experience: Scale 7-Very Satisfied
|
66.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
DNS Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
DNS Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
DNS Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
DNS Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
DNS Experience: Scale 5
|
20.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
DNS Experience: Scale 6
|
33.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
DNS Experience: Scale 7-Very Satisfied
|
46.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
Investigator Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
Investigator Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
Investigator Experience: Scale 3
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
Investigator Experience: Scale 4
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
Investigator Experience: Scale 5
|
26.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
Investigator Experience: Scale 6
|
46.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
Investigator Experience: Scale 7-Very Satisfied
|
13.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
DNS Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
DNS Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
DNS Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
DNS Experience: Scale 4
|
13.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
DNS Experience: Scale 5
|
26.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
DNS Experience: Scale 6
|
40.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
DNS Experience: Scale 7-Very Satisfied
|
20.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
Investigator Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
Investigator Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
Investigator Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
Investigator Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
Investigator Experience: Scale 5
|
13.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
Investigator Experience: Scale 6
|
13.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
Investigator Experience: Scale 7-Very Satisfied
|
73.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
DNS Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
DNS Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
DNS Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
DNS Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
DNS Experience: Scale 5
|
13.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
DNS Experience: Scale 6
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
DNS Experience: Scale 7-Very Satisfied
|
80.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
Investigator Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
Investigator Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
Investigator Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
Investigator Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
Investigator Experience: Scale 5
|
20.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
Investigator Experience: Scale 6
|
60.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
Investigator Experience: Scale 7-Very Satisfied
|
20.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
DNS Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
DNS Experience: Scale 2
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
DNS Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
DNS Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
DNS Experience: Scale 5
|
26.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
DNS Experience: Scale 6
|
20.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
DNS Experience: Scale 7-Very Satisfied
|
46.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
Investigator Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
Investigator Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
Investigator Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
Investigator Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
Investigator Experience: Scale 5
|
13.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
Investigator Experience: Scale 6
|
46.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
Investigator Experience: Scale 7-Very Satisfied
|
40.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
DNS Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
DNS Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
DNS Experience: Scale 3
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
DNS Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
DNS Experience: Scale 5
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
DNS Experience: Scale 6
|
20.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
DNS Experience: Scale 7-Very Satisfied
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
Investigator Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
Investigator Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
Investigator Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
Investigator Experience: Scale 4
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
Investigator Experience: Scale 5
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
Investigator Experience: Scale 6
|
26.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
Investigator Experience: Scale 7-Very Satisfied
|
66.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
DNS Experience: Scale 1-Very Dissatisfied
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
DNS Experience: Scale 2
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
DNS Experience: Scale 3
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
DNS Experience: Scale 4
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
DNS Experience: Scale 5
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
DNS Experience: Scale 6
|
20.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
DNS Experience: Scale 7-Very Satisfied
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'yes' or 'no' for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?
Investigator Experience
|
73.3 Percentage of participants
|
|
Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?
DNS Experience
|
60.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?
Investigator Experience: More
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?
Investigator Experience: Equal
|
40.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?
Investigator Experience: Less
|
60.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?
DNS Experience: More
|
0.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?
DNS Experience: Equal
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?
DNS Experience: Less
|
93.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?
Investigator Experience: More
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?
Investigator Experience: Equal
|
26.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?
Investigator Experience: Less
|
66.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?
DNS Experience: More
|
26.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?
DNS Experience: Equal
|
13.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?
DNS Experience: Less
|
60.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?
Investigator Experience: More
|
53.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?
Investigator Experience: Equal
|
40.0 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?
Investigator Experience: Less
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?
DNS Experience: More
|
93.3 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?
DNS Experience: Equal
|
6.7 Percentage of participants
|
|
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?
DNS Experience: Less
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
Scale 1 (Very Dissatisfied)
|
0.0 Percentage of participants
|
|
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
Scale 2
|
0.0 Percentage of participants
|
|
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
Scale 3
|
0.0 Percentage of participants
|
|
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
Scale 4
|
6.7 Percentage of participants
|
|
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
Scale 5
|
13.3 Percentage of participants
|
|
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
Scale 6
|
20.0 Percentage of participants
|
|
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
Scale 7 (Very Satisfied)
|
60.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
CGI-I was used to document the Investigator's impression of the participant's improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=14 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
Very Much Improved
|
28.6 Percentage of participants
|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
Much Improved
|
71.4 Percentage of participants
|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
Minimally Improved
|
0.0 Percentage of participants
|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
No Change
|
0.0 Percentage of participants
|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
Minimally Worse
|
0.0 Percentage of participants
|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
Much Worse
|
0.0 Percentage of participants
|
|
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
Very Much Worse
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider
General Practitioner
|
0 Number of participants
|
|
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider
Emergency Ward
|
0 Number of participants
|
|
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider
Other Neurologist
|
0 Number of participants
|
|
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider
Other
|
1 Number of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS, defined as all participants that started Duodopa titration.
The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=15 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact
Other
|
0 Number of participants
|
|
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact
Telephone
|
0 Number of participants
|
|
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact
Home or Outpatient Visit
|
1 Number of participants
|
|
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact
Hospitalization
|
0 Number of participants
|
SECONDARY outcome
Timeframe: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 daysPopulation: The analysis was performed using FAS with non-missing information.
The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.
Outcome measures
| Measure |
Participants With Parkinson's Disease
n=1 Participants
Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
|
|---|---|
|
Median Time Spent for Health Care Utilization Outside the TM Care Chain
|
190.8 Minutes
Interval 190.8 to 190.8
|
Adverse Events
Participants With Parkinson's Disease
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER