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Reward-Based Recovery Outcomes Management for Opioid Use Disorder

PROCare: Cloud Process Support for Opioid Recovery Participation and Learning

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04669249
Enrollment
13
Registered
2020-12-16
Start date
2022-03-01
Completion date
2022-09-29
Last updated
2023-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Brief summary

A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.

Interventions

BEHAVIORALPROCare

PROCare is a reward-based digital recovery management platform 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 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 smartphone app.

Sponsors

PRO Health Group
CollaboratorINDUSTRY
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Medical Decision Logic, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years of age or older * access to internet-enabled smartphone device * primary DSM-5 opioid use disorder diagnosis * receiving medication treatment for opioid use disorder with buprenorphine * English language proficient

Exclusion criteria

* active suicidal ideation or psychotic symptoms

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Completing Outcomes Monitoring Surveys4-weekAssessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.
Percentage of Participants Fully-Adherent to Buprenorphine4-weekAssessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.
Percentage of Participants Fully-Adherent to Care Plan4-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.

Secondary

MeasureTime frameDescription
Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up4-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.
Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up4-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.
Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up4-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.
Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up4-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.
Motivation as Assessed by Readiness Ruler4-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).
Percentage of Participants Using Opioids4-weekAssessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period.
Percentage of Participants Using Other Substances (Non-opioids)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).

Other

MeasureTime frameDescription
Usability of PROCare App as Assessed by System Usability Scale (SUS)4-weekSUS 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
PROCare Recovery
Technology-enabled, reward-based recovery mobile app
8
Control
Treatment-as-Usual
5
Total13

Baseline characteristics

CharacteristicPROCare RecoveryTotalControl
Age, Continuous38.00 years
STANDARD_DEVIATION 10.76
36.38 years
STANDARD_DEVIATION 8.88
33.80 years
STANDARD_DEVIATION 4.55
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants8 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants5 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
6 Participants10 Participants4 Participants
Region of Enrollment
United States
8 participants13 participants5 participants
Sex: Female, Male
Female
6 Participants10 Participants4 Participants
Sex: Female, Male
Male
2 Participants3 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 4
other
Total, other adverse events
0 / 70 / 4
serious
Total, serious adverse events
0 / 70 / 4

Outcome results

Primary

Percentage of Participants Completing Outcomes Monitoring Surveys

Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.

Time frame: 4-week

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PROCare RecoveryPercentage of Participants Completing Outcomes Monitoring Surveys7 Participants
ControlPercentage of Participants Completing Outcomes Monitoring Surveys4 Participants
Primary

Percentage of Participants Fully-Adherent to Buprenorphine

Assessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.

Time frame: 4-week

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PROCare RecoveryPercentage of Participants Fully-Adherent to Buprenorphine6 Participants
ControlPercentage of Participants Fully-Adherent to Buprenorphine3 Participants
Primary

Percentage of Participants Fully-Adherent to Care Plan

Assessed 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.

Time frame: 4-week

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PROCare RecoveryPercentage of Participants Fully-Adherent to Care PlanAll Appointments4 Participants
PROCare RecoveryPercentage of Participants Fully-Adherent to Care PlanTherapy Sessions6 Participants
ControlPercentage of Participants Fully-Adherent to Care PlanAll Appointments2 Participants
ControlPercentage of Participants Fully-Adherent to Care PlanTherapy Sessions3 Participants
Secondary

Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up

OCS 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.

Time frame: 4-week

ArmMeasureValue (MEAN)Dispersion
PROCare RecoveryChange in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up19.42 score on a scaleStandard Deviation 22.69
ControlChange in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up16.50 score on a scaleStandard Deviation 22.13
Secondary

Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up

Participant 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.

Time frame: 4-week

ArmMeasureValue (MEAN)Dispersion
PROCare RecoveryChange in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up9.86 score on a scaleStandard Deviation 1.86
ControlChange in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up7.50 score on a scaleStandard Deviation 5.74
Secondary

Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up

The 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.

Time frame: 4-week

ArmMeasureValue (MEAN)Dispersion
PROCare RecoveryChange in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up4.57 score on a scaleStandard Deviation 7.09
ControlChange in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up1.50 score on a scaleStandard Deviation 9.88
Secondary

Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up

BSCQ 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.

Time frame: 4-week

ArmMeasureValue (MEAN)Dispersion
PROCare RecoveryChange in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up54.62 score on a scaleStandard Deviation 16.18
ControlChange in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up38.44 score on a scaleStandard Deviation 25.52
Secondary

Motivation as Assessed by Readiness Ruler

Readiness 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).

Time frame: 4-week

ArmMeasureValue (MEAN)Dispersion
PROCare RecoveryMotivation as Assessed by Readiness Ruler93.49 score on a scaleStandard Deviation 6.45
ControlMotivation as Assessed by Readiness Ruler89.31 score on a scaleStandard Deviation 13.69
Secondary

Percentage of Participants Using Opioids

Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period.

Time frame: 4-week

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PROCare RecoveryPercentage of Participants Using Opioids1 Participants
ControlPercentage of Participants Using Opioids1 Participants
Secondary

Percentage of Participants Using Other Substances (Non-opioids)

Assessed 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).

Time frame: 4-week

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PROCare RecoveryPercentage of Participants Using Other Substances (Non-opioids)2 Participants
ControlPercentage of Participants Using Other Substances (Non-opioids)2 Participants
Other Pre-specified

Usability of PROCare App as Assessed by System Usability Scale (SUS)

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.

Time frame: 4-week

Population: Only participants who used the PROCare Recovery app were administered the measure of app usability.

ArmMeasureValue (MEAN)Dispersion
PROCare RecoveryUsability of PROCare App as Assessed by System Usability Scale (SUS)88.93 score on a scaleStandard Deviation 10.49

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026