Trial Outcomes & Findings for Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform (NCT NCT04868500)
NCT ID: NCT04868500
Last Updated: 2023-02-08
Results Overview
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 1 to 4.
COMPLETED
NA
49 participants
Weeks 1 to 4
2023-02-08
Participant Flow
Participant milestones
| Measure |
Massachusetts General Hospital (MGH) Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
Massachusetts General Hospital (MGH) Clinical Site Staff
Clinical site staff used the AMAZE™ dashboard for six months to identify usability and barriers, benefits, challenges, ease of implementation, and areas for improvement of the AMAZE™ dashboard in a clinical setting.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
7
|
|
Overall Study
Not Started
|
4
|
1
|
|
Overall Study
COMPLETED
|
38
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Massachusetts General Hospital (MGH) Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
Massachusetts General Hospital (MGH) Clinical Site Staff
Clinical site staff used the AMAZE™ dashboard for six months to identify usability and barriers, benefits, challenges, ease of implementation, and areas for improvement of the AMAZE™ dashboard in a clinical setting.
|
|---|---|---|
|
Overall Study
Participants and Clinical Site Staff terminated early
|
3
|
1
|
|
Overall Study
Participants and Clinical Site Staff never opened App
|
1
|
0
|
Baseline Characteristics
Data only collected for MGH Participants arm for this baseline measure.
Baseline characteristics by cohort
| Measure |
Massachusetts General Hospital (MGH) Participants
n=38 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
Massachusetts General Hospital (MGH) Clinical Site Staff
n=6 Participants
Clinical site staff used the AMAZE™ dashboard for six months to identify usability and barriers, benefits, challenges, ease of implementation, and areas for improvement of the AMAZE™ dashboard in a clinical setting.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.5 Years
STANDARD_DEVIATION 12.0 • n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
24.5 Years
STANDARD_DEVIATION 12.0 • n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Sex: Female, Male
Female
|
26 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
0 Participants
Data only collected for MGH Participants arm for this baseline measure.
|
26 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Sex: Female, Male
Male
|
12 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
0 Participants
Data only collected for MGH Participants arm for this baseline measure.
|
12 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
7 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
30 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
1 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
0 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
0 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
0 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
2 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Race (NIH/OMB)
White
|
33 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
33 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
0 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
—
|
3 Participants
n=38 Participants • Data only collected for MGH Participants arm for this baseline measure.
|
PRIMARY outcome
Timeframe: Weeks 1 to 4Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter.
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 1 to 4.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=36 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Home
|
16.8 Days
Standard Deviation 7.1
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Daily asthma log
|
16.5 Days
Standard Deviation 6.8
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Air quality
|
2.3 Days
Standard Deviation 1.5
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
My plan
|
2.2 Days
Standard Deviation 1.5
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Trends
|
2.8 Days
Standard Deviation 3.0
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Appointments
|
1.3 Days
Standard Deviation 0.5
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Educational material
|
1.0 Days
Standard Deviation 0.0
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Messages
|
2.3 Days
Standard Deviation 2.4
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 1 to 4)
Notifications
|
1.3 Days
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Weeks 5 to 8Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter.
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 5 to 8.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=33 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Home
|
12.5 Days
Standard Deviation 8.6
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Daily asthma log
|
12.1 Days
Standard Deviation 8.6
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Air quality
|
1.5 Days
Standard Deviation 0.7
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
My plan
|
1.6 Days
Standard Deviation 0.8
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Trends
|
1.6 Days
Standard Deviation 0.8
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Appointments
|
1.3 Days
Standard Deviation 0.5
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Educational material
|
1.0 Days
Standard Deviation 0.0
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Messages
|
1.8 Days
Standard Deviation 1.5
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 5 to 8)
Notifications
|
1.0 Days
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Weeks 9 to 12Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter.
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 9 to 12.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=30 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Home
|
11.4 Days
Standard Deviation 8.1
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Daily asthma log
|
11.2 Days
Standard Deviation 7.8
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Air quality
|
1.0 Days
Standard Deviation 0.0
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
My plan
|
1.5 Days
Standard Deviation 1.0
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Trends
|
1.4 Days
Standard Deviation 0.5
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Appointments
|
1.3 Days
Standard Deviation 0.6
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Educational material
|
1.0 Days
Standard Deviation NA
Standard deviation was not reported as only one participant was evaluable for the specified arm group.
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Messages
|
1.4 Days
Standard Deviation 0.5
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 9 to 12)
Notifications
|
1.0 Days
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Weeks 13 to 16Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter.
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 13 to 16.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=25 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Home
|
12.6 Days
Standard Deviation 8.2
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Daily asthma log
|
12.1 Days
Standard Deviation 8.1
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Air quality
|
1.0 Days
Standard Deviation 0.0
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
My plan
|
1.1 Days
Standard Deviation 0.3
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Trends
|
1.1 Days
Standard Deviation 0.3
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Appointments
|
1.2 Days
Standard Deviation 0.4
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Educational material
|
1.0 Days
Standard Deviation 0.0
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Messages
|
1.3 Days
Standard Deviation 0.6
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 13 to 16)
Notifications
|
1.0 Days
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Weeks 17 to 20Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter.
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 17 to 20.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=22 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Home
|
9.3 Days
Standard Deviation 7.5
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Daily asthma log
|
8.9 Days
Standard Deviation 7.2
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Air quality
|
1.0 Days
Standard Deviation NA
Standard deviation was not reported as only one participant was evaluable for the specified arm group.
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
My plan
|
1.2 Days
Standard Deviation 0.4
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Trends
|
1.2 Days
Standard Deviation 0.4
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Appointments
|
1.5 Days
Standard Deviation 0.7
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Educational material
|
1.0 Days
Standard Deviation NA
Standard deviation was not reported as only one participant was evaluable for the specified arm group.
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Messages
|
1.3 Days
Standard Deviation 0.8
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 17 to 20)
Notifications
|
1.0 Days
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Weeks 21 to 24Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants who accessed the App for the specified time frame and 'Number Analyzed' denotes number of participants analyzed for the specified parameter.
Participant App usage was measured as the number of days the participant engaged (ie., participants accessed 'Home, Daily asthma log, Air quality, My plan, Trends, Appointments, Educational material, Messages, and Notifications') with the App during Weeks 21 to 24.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=14 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24)
Home
|
7.6 Days
Standard Deviation 7.2
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24)
Daily asthma log
|
7.8 Days
Standard Deviation 7.3
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24)
My plan
|
1.2 Days
Standard Deviation 0.4
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24)
Trends
|
1.0 Days
Standard Deviation 0.0
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24)
Appointments
|
3.0 Days
Standard Deviation NA
Standard deviation was not reported as only one participant was evaluable for the specified arm group.
|
|
Number of Days Participants Accessed the AMAZE™ App (Weeks 21 to 24)
Messages
|
1.3 Days
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Weeks 1 to 4Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 1 to 4.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=3 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 1 to 4)
|
8.3 Days
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: Weeks 5 to 8Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 5 to 8.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=5 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 5 to 8)
|
5.8 Days
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: Weeks 9 to 12Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 9 to 12.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=5 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 9 to 12)
|
6.6 Days
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: Weeks 13 to 16Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 13 to 16.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=6 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 13 to 16)
|
5.8 Days
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: Weeks 17 to 20Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 17 to 20.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=5 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 17 to 20)
|
5.6 Days
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: Weeks 21 to 24Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
Clinician dashboard usage was measured as the mean number of days that the clinical site staff accessed the AMAZE™ dashboard during Weeks 21 to 24.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=3 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Days Clinical Site Staff Accessed the AMAZE™ Dashboard (Weeks 21 to 24)
|
6.7 Days
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Weeks 1 to 4Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame.
Visit Survey Item 9 was 'The visit helped avoid an emergency room (ER) or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=1 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 1 to 4)
High
|
1 Participants
|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 1 to 4)
Very low
|
0 Participants
|
PRIMARY outcome
Timeframe: Weeks 5 to 8Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame.
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=1 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 5 to 8)
High
|
1 Participants
|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 5 to 8)
Very low
|
0 Participants
|
PRIMARY outcome
Timeframe: Weeks 9 to 12Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame.
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=1 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 9 to 12)
High
|
1 Participants
|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 9 to 12)
Very low
|
0 Participants
|
PRIMARY outcome
Timeframe: Weeks 13 to 16Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame.
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=1 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 13 to 16)
High
|
1 Participants
|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 13 to 16)
Very low
|
0 Participants
|
PRIMARY outcome
Timeframe: Weeks 17 to 20Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame.
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=1 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 17 to 20)
High
|
0 Participants
|
|
Number of Participants Engaged in Agreement of Visit Survey Item 9 (Weeks 17 to 20)
Very low
|
1 Participants
|
PRIMARY outcome
Timeframe: Weeks 21 to 24Population: No participant completed at least one daily asthma log during the specified time frame (Weeks 21 to 24), so no data was reported.
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' Visit surveys were completed throughout the study whenever a participant completed an asthma-related clinic visit. Number of participants engaged in agreement of Visit Survey Item 9 as 'High' (ie., 5-7 days per week per month) and 'Very low' (ie., less than one day per week per month) are reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: End of Study (Month 6)Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
Satisfaction with the AMAZE™ App features was measured by the number of participants who reported satisfaction on parameters of 'Very unsatisfied, Unsatisfied, Neutral, Satisfied, and Very satisfied'.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=22 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Evaluate Participant Satisfaction With the AMAZE™ App (End of Study)
Very unsatisfied
|
1 Participants
|
|
Evaluate Participant Satisfaction With the AMAZE™ App (End of Study)
Unsatisfied
|
0 Participants
|
|
Evaluate Participant Satisfaction With the AMAZE™ App (End of Study)
Neutral
|
3 Participants
|
|
Evaluate Participant Satisfaction With the AMAZE™ App (End of Study)
Satisfied
|
12 Participants
|
|
Evaluate Participant Satisfaction With the AMAZE™ App (End of Study)
Very satisfied
|
6 Participants
|
PRIMARY outcome
Timeframe: End of Study (Month 6)Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
The impact of AMAZE™ on ER, urgent care center visits, and hospitalizations was measured as the number of participants who reported "agree" or "strongly agree" with the question 'Since the start of the study, use of the AMAZE™ App helped me avoid ER or urgent care center visits or hospitalizations.' from the participant visit experience survey.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=22 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Emergency Room Visits, Urgent Care Center Visits, or Hospitalization Avoidance (End of Study)
Strongly agree
|
2 Participants
|
|
Emergency Room Visits, Urgent Care Center Visits, or Hospitalization Avoidance (End of Study)
Agree
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through End of Study (Month 6)Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed for the specified time frame.
Visit Survey Item 9 was 'The visit helped avoid an ER or urgent care center visit or hospitalization.' The impact of AMAZE™ on participant visits was measured as the number of participants who selected "agree" or "strongly agree" in response to the 9-items in the participant visit experience survey.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=20 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Impact of AMAZE™ App on Participants Clinic Visits
Strongly agree
|
2 Participants
|
|
Impact of AMAZE™ App on Participants Clinic Visits
Agree
|
0 Participants
|
PRIMARY outcome
Timeframe: End of Study (Month 6)Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
The impact of AMAZE™ on improved participant communication with their healthcare provider was measured as the number of participants who reported "agree" or "strongly agree" with the questions "The app helped me discuss my asthma with my healthcare providers during my most recent visit?", "App helped the appointment with my doctor go more smoothly?" and "I was included in making decisions about my asthma treatment during my most recent visit?" on the participant visit experience survey.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=20 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study)
Asthma discussions-Strongly Agree
|
3 Participants
|
|
Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study)
Asthma Discussions-Agree
|
5 Participants
|
|
Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study)
To take appointment smoothly-Strongly agree
|
3 Participants
|
|
Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study)
To take appointment smoothly-Agree
|
3 Participants
|
|
Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study)
Asthma treatment decision-Strongly agree
|
14 Participants
|
|
Participant Perception of Appointment Discussions and Taking Part in Asthma Decisions (End of Study)
Asthma treatment decision-Agree
|
4 Participants
|
PRIMARY outcome
Timeframe: End of study (Month 6)Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
Participant satisfaction with their healthcare experience was evaluated using the PSQ-18 items with subscale scores of 'General satisfaction, Technical quality, Interpersonal manner, Communication, Financial aspects, Time spent with doctor, Accessibility and convenience' at End of Study (Month 6). The PSQ-18 scores ranges from 1 to 5 and a higher score indicates greater satisfaction.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=22 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
General satisfaction
|
4.1 Scores on a Scale
Standard Deviation 0.86
|
|
Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
Technical quality
|
4.3 Scores on a Scale
Standard Deviation 0.61
|
|
Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
Interpersonal manner
|
4.3 Scores on a Scale
Standard Deviation 0.57
|
|
Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
Communication
|
4.2 Scores on a Scale
Standard Deviation 0.77
|
|
Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
Financial aspects
|
4.0 Scores on a Scale
Standard Deviation 0.91
|
|
Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
Time spent with doctor
|
3.8 Scores on a Scale
Standard Deviation 0.95
|
|
Patient Satisfaction Questionnaire-18 Subscale Scores (End of Study)
Accessibility and convenience
|
3.6 Scores on a Scale
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: Month 1Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 1.
The usability of the AMAZE™ App was measured by the number of participants who rated the app as 'excellent, good, okay, poor, awful or skipped to report' at Month 1.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=30 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Patient-Reported System Usability Scale (SUS) (Month 1)
Excellent
|
17 Participants
56.7
|
|
Patient-Reported System Usability Scale (SUS) (Month 1)
Good
|
9 Participants
30.0
|
|
Patient-Reported System Usability Scale (SUS) (Month 1)
Okay
|
0 Participants
0.0
|
|
Patient-Reported System Usability Scale (SUS) (Month 1)
Poor
|
3 Participants
10.0
|
|
Patient-Reported System Usability Scale (SUS) (Month 1)
Awful
|
0 Participants
0.0
|
|
Patient-Reported System Usability Scale (SUS) (Month 1)
Skipped
|
1 Participants
3.3
|
PRIMARY outcome
Timeframe: End of Study (Month 6)Population: All eligible participants successfully enrolled in the implementation study were analyzed. Here, 'Number of Participants Analyzed' denotes number of participants analyzed at Month 6.
The usability of the AMAZE™ App was measured by the number of participants who rated the app as 'excellent, good, okay, poor, awful or skipped to report' at End of Study (Month 6).
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=22 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Patient-Reported SUS (End of Study)
Awful
|
2 Participants
9.1
|
|
Patient-Reported SUS (End of Study)
Skipped
|
0 Participants
0.0
|
|
Patient-Reported SUS (End of Study)
Good
|
6 Participants
27.3
|
|
Patient-Reported SUS (End of Study)
Okay
|
0 Participants
0.0
|
|
Patient-Reported SUS (End of Study)
Poor
|
0 Participants
0.0
|
|
Patient-Reported SUS (End of Study)
Excellent
|
14 Participants
63.6
|
PRIMARY outcome
Timeframe: Month 1Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
The usability of the AMAZE™ dashboard was measured by the number of clinical staff who rated the App as 'excellent, good, okay, poor, awful or skipped to report' at Month 1.
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=5 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Clinical Site Staff-Reported SUS (Month 1)
Excellent
|
0 Participants
0.0
|
|
Clinical Site Staff-Reported SUS (Month 1)
Good
|
4 Participants
80.0
|
|
Clinical Site Staff-Reported SUS (Month 1)
Okay
|
0 Participants
0.0
|
|
Clinical Site Staff-Reported SUS (Month 1)
Poor
|
1 Participants
20.0
|
|
Clinical Site Staff-Reported SUS (Month 1)
Awful
|
0 Participants
0.0
|
|
Clinical Site Staff-Reported SUS (Month 1)
Skipped
|
0 Participants
0.0
|
PRIMARY outcome
Timeframe: End of Study (Month 6)Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
The usability of the AMAZE™ dashboard was measured by the number of clinical staff who rated the App as 'excellent, good, okay, poor, awful or skipped to report' at End of Study (Month 6).
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=4 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Clinical Site Staff-Reported SUS (End of Study)
Excellent
|
1 Participants
25.0
|
|
Clinical Site Staff-Reported SUS (End of Study)
Good
|
1 Participants
25.0
|
|
Clinical Site Staff-Reported SUS (End of Study)
Okay
|
0 Participants
0.0
|
|
Clinical Site Staff-Reported SUS (End of Study)
Poor
|
1 Participants
25.0
|
|
Clinical Site Staff-Reported SUS (End of Study)
Awful
|
0 Participants
0.0
|
|
Clinical Site Staff-Reported SUS (End of Study)
Skipped
|
1 Participants
25.0
|
PRIMARY outcome
Timeframe: End of Study (Month 6)Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
The ease of implementation of AMAZE™ was measured by the number of clinical staff who reported "very easy" or "somewhat easy" to the question "How would you rate the overall ease of implementing AMAZE™ on a platform into your clinical practice?" in the post-study survey at End of Study (Month 6).
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=6 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Evaluate Ease of Implementation of AMAZE™ App in Clinical Setting (End of Study)
Very easy
|
4 Participants
|
|
Evaluate Ease of Implementation of AMAZE™ App in Clinical Setting (End of Study)
Somewhat easy
|
0 Participants
|
PRIMARY outcome
Timeframe: End of Study (Month 6)Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
The impact of AMAZE™ on managing participants was measured by the number of clinical staff who reported "moderately" or "very well" to the question "Did the AMAZE™ help you manage your participants?" in the post-study survey at End of Study (Month 6).
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=6 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Evaluate Impact of AMAZE™ App on Managing Participants (End of Study)
Moderately
|
2 Participants
|
|
Evaluate Impact of AMAZE™ App on Managing Participants (End of Study)
Very well
|
0 Participants
|
PRIMARY outcome
Timeframe: End of Study (Month 6)Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
The perceived benefit of AMAZE™ was evaluated by the number of clinical staff who endorsed different perceived benefits as "Ability to track symptoms, Ability to track asthma triggers, Ability to track reliever medication use, Ability track ER visits/ hospitalizations, and Integration of AMAZE™ platform with electronic health records" based on the item "What did you find the most useful about the AMAZE™ platform?" in the post-study survey at End of Study (Month 6).
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=6 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study)
Ability to track symptoms
|
2 Participants
|
|
Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study)
Ability to track asthma triggers
|
1 Participants
|
|
Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study)
Ability to track reliever medication use
|
2 Participants
|
|
Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study)
Ability track ER visits/ hospitalizations
|
0 Participants
|
|
Evaluate Perceived Benefit of AMAZE™ App in Clinical Setting (End of Study)
Integration of AMAZE™ platform with electronic health records
|
2 Participants
|
PRIMARY outcome
Timeframe: End of Study (Month 6).Population: Clinical site staff who used the AMAZE™ dashboard at the specified time frame were considered for this outcome measure.
The perceived disadvantages of AMAZE™ were evaluated by the number of clinical site staff who endorsed different perceived disadvantages as "Ability to track air flow measurements, Participant-health care provides (HCP) messaging feature, Ability to assign another healthcare provider to a participant, Ability to track level of impairment through Asthma Control Test (ACT™) scores" based on the question "What did you find the least useful or cumbersome about the AMAZE™ platform?" in the post-study survey at End of Study (Month 6).
Outcome measures
| Measure |
Massachusetts General Hospital (MGH) Participants
n=6 Participants
Participants used the AMAZE™ application to enter daily asthma symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials up to six months.
|
|---|---|
|
Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study)
Ability to track air flow measurements
|
1 Participants
|
|
Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study)
Participant-HCP messaging feature
|
2 Participants
|
|
Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study)
Ability to assign another healthcare provider to a participant
|
1 Participants
|
|
Evaluate Perceived Disadvantages of AMAZE™ in Clinical Setting (End of Study)
Ability to track level of impairment through ACT™ scores
|
1 Participants
|
Adverse Events
Massachusetts General Hospital (MGH) Participants
Massachusetts General Hospital (MGH) Clinical Site Staff
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER