Trial Outcomes & Findings for Pilot Study of Annie Text Messaging for Depression Treatment Adherence (NCT NCT03930849)
NCT ID: NCT03930849
Last Updated: 2023-07-27
Results Overview
Medication Adherence Rating Scale - 10 item self-report measure of medication taking attitudes, behaviors, and side effects. It is scored on a 0-10 scale with higher scores indicating greater adherence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
Baseline, 6 and 12 weeks
Results posted on
2023-07-27
Participant Flow
Participant milestones
| Measure |
AIMS Intervention
Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.
AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
No Intervention
Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
|
AIMS Intervention Plus
Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.
AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
18
|
|
Overall Study
COMPLETED
|
13
|
18
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Annie Text Messaging for Depression Treatment Adherence
Baseline characteristics by cohort
| Measure |
AIMS Intervention
n=17 Participants
Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.
AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
No Intervention
n=18 Participants
Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
|
AIMS Intervention Plus
n=18 Participants
Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.
AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.11 years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
49.55 years
STANDARD_DEVIATION 14.74 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 14.26 • n=5 Participants
|
45.72 years
STANDARD_DEVIATION 13.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 and 12 weeksMedication Adherence Rating Scale - 10 item self-report measure of medication taking attitudes, behaviors, and side effects. It is scored on a 0-10 scale with higher scores indicating greater adherence.
Outcome measures
| Measure |
AIMS Intervention
n=13 Participants
Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.
AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
No Intervention
n=18 Participants
Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
|
AIMS Intervention Plus
n=14 Participants
Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.
AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
|---|---|---|---|
|
Medication Adherence at Baseline, 6 Weeks and 12 Weeks
Baseline
|
3.41 score on a scale
Standard Error 0.46
|
1.32 score on a scale
Standard Error 0.45
|
2.55 score on a scale
Standard Error 0.45
|
|
Medication Adherence at Baseline, 6 Weeks and 12 Weeks
6-Weeks
|
2.66 score on a scale
Standard Error 0.48
|
1.44 score on a scale
Standard Error 0.45
|
2.16 score on a scale
Standard Error 0.47
|
|
Medication Adherence at Baseline, 6 Weeks and 12 Weeks
12-Weeks
|
2.58 score on a scale
Standard Error 0.48
|
1.56 score on a scale
Standard Error 0.45
|
2.57 score on a scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 weeksPatient Health Questionnaire (PHQ-9) - a standard instrument for measuring depressive symptom severity and monitoring treatment outcomes over time. A score of 4 or less indicates minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 indicates severe depression. The total score may range from 0 -27.
Outcome measures
| Measure |
AIMS Intervention
n=13 Participants
Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.
AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
No Intervention
n=18 Participants
Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
|
AIMS Intervention Plus
n=14 Participants
Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.
AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
|---|---|---|---|
|
Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks
Baseline
|
15.41 units on a scale
Standard Error 1.43
|
13.27 units on a scale
Standard Error 1.38
|
12.00 units on a scale
Standard Error 1.38
|
|
Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks
6-Weeks
|
13.34 units on a scale
Standard Error 1.55
|
11.38 units on a scale
Standard Error 1.38
|
9.29 units on a scale
Standard Error 1.50
|
|
Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks
12-Weeks
|
12.20 units on a scale
Standard Error 1.58
|
11.45 units on a scale
Standard Error 1.40
|
8.70 units on a scale
Standard Error 1.56
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 weeksThe Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER): The 3-item FIBSER asks about the frequency, severity, and functional impact of antidepressant side effects using a 0 to 6- Likert scale. The prevalence and distribution of scores for each domain will be compared across assessment time points. Higher scores indicate greater side effect burden while lower scores indicate lesser. The range for the total score on the measure can span from 0 to 18. A decline in total score is the desired outcome.
Outcome measures
| Measure |
AIMS Intervention
n=13 Participants
Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.
AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
No Intervention
n=18 Participants
Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
|
AIMS Intervention Plus
n=14 Participants
Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.
AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
|
|---|---|---|---|
|
Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks
Baseline
|
6.05 units on a scale
Standard Error 1.00
|
3.38 units on a scale
Standard Error 0.97
|
3.55 units on a scale
Standard Error 0.97
|
|
Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks
6-Weeks
|
3.83 units on a scale
Standard Error 1.11
|
4.88 units on a scale
Standard Error 0.97
|
1.51 units on a scale
Standard Error 1.07
|
|
Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks
12-Weeks
|
4.06 units on a scale
Standard Error 1.11
|
3.73 units on a scale
Standard Error 1.01
|
2.53 units on a scale
Standard Error 1.14
|
Adverse Events
AIMS Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AIMS Intervention Plus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place