Trial Outcomes & Findings for A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence (NCT NCT03379233)
NCT ID: NCT03379233
Last Updated: 2021-01-05
Results Overview
On-time treatment adherence was defined as percentage of days on which the participant inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed predefined preferred daily inhalation time (PIT). PIT was defined by the participant at study start.
TERMINATED
PHASE3
7 participants
Baseline 6 weeks, intervention 24 weeks
2021-01-05
Participant Flow
This study was conducted at Netherlands and Germany between 11 July 2018 (first participant first visit) and 22 January 2019 (last participant last visit).
A total of 7 subjects were randomized in the study.
Participant milestones
| Measure |
Telehealth Group
Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.
|
Usual Care Group
Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Telehealth Group
Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.
|
Usual Care Group
Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.
|
|---|---|---|
|
Overall Study
Technical issues with Concept 2 inhalers
|
1
|
6
|
Baseline Characteristics
A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence
Baseline characteristics by cohort
| Measure |
Telehealth Group
n=1 Participants
Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.
|
Usual Care Group
n=6 Participants
Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline 6 weeks, intervention 24 weeksPopulation: Due to technical issues, the actual time and day of inhaler use from the point of resetting could not be evaluated. Therefore data for this outcome measure were not collected and reported.
On-time treatment adherence was defined as percentage of days on which the participant inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed predefined preferred daily inhalation time (PIT). PIT was defined by the participant at study start.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline 6 weeks, intervention 24 weeksPopulation: Due to technical issues, the actual time and day of inhaler use from the point of resetting could not be evaluated. Therefore data for this outcome measure were not collected and reported.
Total adherence was defined as percentage of days on which the participant inhaled at least one dose and represented the sum of on-time adherence and off-time adherence. Off-time adherence was defined as percentage of days on which the participant did not inhale the daily dose within the (+ or -) 2 hours of the predefined PIT, but outside. The number of doses not inhaled on-time was recorded by the Concept2 inhaler.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 21 - 24Population: Due to the early discontinuation of the study, only very few participants were randomized (7) and no participant completed the last 4 weeks of intervention, required for the evaluation of the secondary efficacy outcome measure. Therefore data for this outcome measure was not collected and reported.
On-time treatment adherence was defined as percentage of days on which the participant inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed predefined preferred daily inhalation time (PIT). PIT was defined by the participant at study start.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 21 - 24Population: Due to the early discontinuation of the study, only very few participants were randomized (7) and no participant completed the last 4 weeks of intervention, required for the evaluation of the secondary efficacy outcome measure. Therefore data for this outcome measure was not collected and reported.
Total adherence was defined as percentage of days on which the participant inhaled at least one dose and represented the sum of on-time adherence and off-time adherence. Off-time adherence was defined as percentage of days on which the participant did not inhale the daily dose within the (+ or -) 2 hours of the predefined PIT, but outside. The number of doses not inhaled on-time was recorded by the Concept2 inhaler.
Outcome measures
Outcome data not reported
Adverse Events
Telehealth Group
Usual Care Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Telehealth Group
n=1 participants at risk
Participants inhaled Ultibro Breezhaler 110/50 micrograms (mcg) clinical formulation once daily via Concept2 inhaler with an electronic connectivity to a patient application pre-installed on a tablet device for 24 weeks.
|
Usual Care Group
n=6 participants at risk
Participants inhaled Ultibro Breezhaler 110/50 mcg capsule once daily via Concept2 inhaler for 24 weeks.
|
|---|---|---|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • Treatment emergent adverse events were reported from start of treatment up to follow up (34 weeks)
Enrolled set consisted of participants who signed informed consent and had some assessment done in the screening period.
|
16.7%
1/6 • Treatment emergent adverse events were reported from start of treatment up to follow up (34 weeks)
Enrolled set consisted of participants who signed informed consent and had some assessment done in the screening period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Treatment emergent adverse events were reported from start of treatment up to follow up (34 weeks)
Enrolled set consisted of participants who signed informed consent and had some assessment done in the screening period.
|
33.3%
2/6 • Treatment emergent adverse events were reported from start of treatment up to follow up (34 weeks)
Enrolled set consisted of participants who signed informed consent and had some assessment done in the screening period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER