Trial Outcomes & Findings for Reward-Based Recovery Outcomes Management for Opioid Use Disorder (NCT NCT04669249)
NCT ID: NCT04669249
Last Updated: 2023-03-17
Results Overview
Assessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.
COMPLETED
NA
13 participants
4-week
2023-03-17
Participant Flow
Participant milestones
| Measure |
PROCare Recovery
PROCare Recovery is a technology-enabled, reward-based digital recovery management mobile app for individuals receiving medication treatment for opioid use disorder. Patients have the opportunity to earn both non-monetary and monetary incentives via smart debit card for a variety of clinically-indicated behaviors, including taking their medication (buprenorphine) as directed, attending clinic appointments (e.g., therapy sessions) and community-based mutual-help support group meetings, participating in routine outcomes monitoring surveys using validated measures, accessing the curated psychoeducation content library, and engaging in other recovery-oriented activities within the app.
|
Control
Treatment-as-Usual
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reward-Based Recovery Outcomes Management for Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
PROCare Recovery
n=8 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=5 Participants
Treatment-as-Usual
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.00 years
STANDARD_DEVIATION 10.76 • n=5 Participants
|
33.80 years
STANDARD_DEVIATION 4.55 • n=7 Participants
|
36.38 years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-weekAssessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=4 Participants
Treatment-as-Usual
|
|---|---|---|
|
Percentage of Participants Fully-Adherent to Buprenorphine
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 4-weekAssessed by % of participants fully-adherent to weekly outpatient individual therapy visits, community-based mutual-help recovery support meetings, and other scheduled appointments attended during study period with higher values indicating greater care plan adherence.
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=4 Participants
Treatment-as-Usual
|
|---|---|---|
|
Percentage of Participants Fully-Adherent to Care Plan
All Appointments
|
4 Participants
|
2 Participants
|
|
Percentage of Participants Fully-Adherent to Care Plan
Therapy Sessions
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 4-weekAssessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.
Outcome measures
| Measure |
PROCare Recovery
n=8 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=5 Participants
Treatment-as-Usual
|
|---|---|---|
|
Percentage of Participants Completing Outcomes Monitoring Surveys
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 4-weekAssessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period.
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=4 Participants
Treatment-as-Usual
|
|---|---|---|
|
Percentage of Participants Using Opioids
|
1 Participants
|
1 Participants
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SECONDARY outcome
Timeframe: 4-weekAssessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period for non-opioids substances (alcohol, cannabis, methamphetamine, amphetamines, cocaine, benzodiazepines).
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=4 Participants
Treatment-as-Usual
|
|---|---|---|
|
Percentage of Participants Using Other Substances (Non-opioids)
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4-weekThe EUROHIS-QOL (European Health Interview Survey-Quality of Life) 8-item index is an efficient, valid, and reliable measure of four quality of life domains (physical, psychological, environmental, and social). Items are rated on a 5-point Likert-type scale and summed to produce a total quality of life score (Range: 8-40) with higher scores indicating a higher level of satisfaction with their current quality of life. Change in scores from baseline to 4-week follow-up was examined with a higher change score indicating a greater increase in participant quality of life.
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=4 Participants
Treatment-as-Usual
|
|---|---|---|
|
Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up
|
4.57 score on a scale
Standard Deviation 7.09
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1.50 score on a scale
Standard Deviation 9.88
|
SECONDARY outcome
Timeframe: 4-weekOCS is a 3-item measure of opioid craving with acceptable internal consistency, reliability, and concurrent/predictive validity. Participants rate their level of craving in reference to three situations (current, past week, and high-risk environment) on a scale ranging from 0-10 to produce a total score ranging from 0-30 with higher scores indicating greater reduction in craving. Change in OCS scores from baseline to 4-week follow-up was examined to determine reductions in craving.
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=4 Participants
Treatment-as-Usual
|
|---|---|---|
|
Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up
|
19.42 score on a scale
Standard Deviation 22.69
|
16.50 score on a scale
Standard Deviation 22.13
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SECONDARY outcome
Timeframe: 4-weekReadiness Ruler is a valid and reliable 2-item measure of motivation and readiness to change. Participants rate their perceived "Importance" of making a change to their drug use behaviors, and their perceived "Confidence" in their ability to successfully achieve their goal (range: 0-100) with higher scores indicating greater motivation. Perceived "Importance" and "Confidence" scores are averaged to indicate a total Motivation score at 4-week follow-up (Range: 0-100).
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=4 Participants
Treatment-as-Usual
|
|---|---|---|
|
Motivation as Assessed by Readiness Ruler
|
93.49 score on a scale
Standard Deviation 6.45
|
89.31 score on a scale
Standard Deviation 13.69
|
SECONDARY outcome
Timeframe: 4-weekBSCQ is an 8-item measure of self-efficacy for resisting the urge to use drugs in 8 high-risk situations based on the relapse prevention model (unpleasant emotions, physical discomfort, pleasant emotions, testing control, urges/temptations, interpersonal conflict, social pressure, and pleasant times with others). Patients rate their confidence in resisting the urge to use drugs in each of the 8 situations on a scale ranging from 0 (Not at all Confident) to 100 (Extremely Confident). Scores for each of the 8 situations are averaged to produce a total self-efficacy score (Range: 0-100). Change in scores from baseline to 4-week follow-up was examined with higher scores indicating a greater increase in self-efficacy.
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=4 Participants
Treatment-as-Usual
|
|---|---|---|
|
Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up
|
54.62 score on a scale
Standard Deviation 16.18
|
38.44 score on a scale
Standard Deviation 25.52
|
SECONDARY outcome
Timeframe: 4-weekParticipant self-report will be used to determine frequency counts of the 11 opioid use disorder diagnostic criteria per Diagnostic \& Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with higher counts indicating a greater number of symptoms/opioid-related impairment present and higher opioid use disorder severity. Total score indicating the total number of positive diagnostic criteria ranges from 0-11. Change in the number of diagnostic criteria endorsed from baseline to 4-week follow-up was examined to determine reduction in opioid-related impairment with higher scores indicating a greater reduction in symptoms over time.
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
n=4 Participants
Treatment-as-Usual
|
|---|---|---|
|
Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up
|
9.86 score on a scale
Standard Deviation 1.86
|
7.50 score on a scale
Standard Deviation 5.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4-weekPopulation: Only participants who used the PROCare Recovery app were administered the measure of app usability.
SUS is a 10-item measure commonly used for global assessments of systems usability. SUS scores will be used to objectively quantify the usability of the PROCare recovery app. Participants allocated to the PROCare condition will rate the usability of the app on 10 items assessing different aspects of usability using a Likert-type scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) with higher converted total scores indicating a higher level of overall usability. Converted total scores range from 0-100 with SUS scores above 68 considered Above Average.
Outcome measures
| Measure |
PROCare Recovery
n=7 Participants
Technology-enabled, reward-based recovery mobile app
|
Control
Treatment-as-Usual
|
|---|---|---|
|
Usability of PROCare App as Assessed by System Usability Scale (SUS)
|
88.93 score on a scale
Standard Deviation 10.49
|
—
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Adverse Events
PROCare Recovery
Control
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