Trial Outcomes & Findings for Mobile After-Care Support App: Pilot RCT (NCT NCT03955250)
NCT ID: NCT03955250
Last Updated: 2024-03-19
Results Overview
The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
1 month
Results posted on
2024-03-19
Participant Flow
Participant milestones
| Measure |
Mobile After-Care Support (MACS) App
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.
Mobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.
|
Mobile App Attention Control
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.
Mobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
23
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile After-Care Support App: Pilot RCT
Baseline characteristics by cohort
| Measure |
Mobile After-Care Support (MACS) App
n=19 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.
Mobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.
|
Mobile App Attention Control
n=23 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.
Mobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
35.1 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
34.3 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 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
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 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
United States
|
19 participants
n=5 Participants
|
23 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: The number of participants analyzed is lower than the number enrolled due to missing data on this measure.
The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.
Outcome measures
| Measure |
Mobile After-Care Support (MACS) App
n=10 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.
Mobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.
|
Mobile App Attention Control
n=12 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.
Mobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.
|
|---|---|---|
|
Client Satisfaction Questionnaire (CSQ)
|
23.7 score on a scale
Standard Deviation 4.4
|
22.5 score on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline, 4 monthPopulation: This analysis was intent-to-treat based on all participants initially enrolled in the study.
The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.
Outcome measures
| Measure |
Mobile After-Care Support (MACS) App
n=19 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.
Mobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.
|
Mobile App Attention Control
n=23 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.
Mobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS)
Baseline
|
53.1 score on a scale
Standard Error 2.4
|
49.8 score on a scale
Standard Error 2.2
|
|
Brief Psychiatric Rating Scale (BPRS)
4 Month
|
36.4 score on a scale
Standard Error 2.6
|
33.1 score on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline, 4 monthPopulation: This analysis was intent-to-treat based on all participants initially enrolled in the study.
The Brief Adherence Rating Scale assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence.
Outcome measures
| Measure |
Mobile After-Care Support (MACS) App
n=19 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.
Mobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.
|
Mobile App Attention Control
n=23 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.
Mobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.
|
|---|---|---|
|
Brief Adherence Rating Scale (BARS)
Baseline
|
86.2 units on a scale
Standard Error 4.8
|
83.8 units on a scale
Standard Error 4.4
|
|
Brief Adherence Rating Scale (BARS)
4 Month
|
94.4 units on a scale
Standard Error 4.9
|
92.0 units on a scale
Standard Error 4.8
|
SECONDARY outcome
Timeframe: Baseline, 4 monthPopulation: This analysis was intent-to-treat based on all participants initially enrolled in the study.
The Brief Cope Inventory is a 28 item self-report measure of coping skills. The mean values of the 12-item dysfunctional coping subscale was used. Mean scores for the total range from 1-48 with higher scores indicating greater use of the dysfunctional coping strategies.
Outcome measures
| Measure |
Mobile After-Care Support (MACS) App
n=19 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.
Mobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.
|
Mobile App Attention Control
n=23 Participants
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.
Mobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.
|
|---|---|---|
|
Brief Cope Inventory (Brief COPE)
Baseline
|
28.6 score on a scale
Standard Error 1.6
|
28.1 score on a scale
Standard Error 1.5
|
|
Brief Cope Inventory (Brief COPE)
4 Month
|
24.8 score on a scale
Standard Error 1.7
|
24.4 score on a scale
Standard Error 1.7
|
Adverse Events
Mobile After-Care Support (MACS) App
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Mobile App Attention Control
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mobile After-Care Support (MACS) App
n=19 participants at risk
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention.
Mobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.
|
Mobile App Attention Control
n=23 participants at risk
All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness.
Mobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness.
|
|---|---|---|
|
Psychiatric disorders
Rehospitalization
|
47.4%
9/19 • 4 months
|
39.1%
9/23 • 4 months
|
|
Psychiatric disorders
Suicide attempt
|
10.5%
2/19 • 4 months
|
0.00%
0/23 • 4 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place