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OpenTrials
Completed

NCT Number: NCT04669249

Reward-Based Recovery Outcomes Management for Opioid Use Disorder

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Florida Behavioral Health Network, Inc.

Miami, Florida, 33126, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROCare

Behavioral

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.

Primary outcomes

  1. Percentage of Participants Fully-Adherent to Buprenorphine

    Time frame: 4-week

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

  2. Percentage of Participants Fully-Adherent to Care Plan

    Time frame: 4-week

    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.

  3. Percentage of Participants Completing Outcomes Monitoring Surveys

    Time frame: 4-week

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

Secondary outcomes

  1. Percentage of Participants Using Opioids

    Time frame: 4-week

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

  2. Percentage of Participants Using Other Substances (Non-opioids)

    Time frame: 4-week

    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).

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

    Time frame: 4-week

    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.

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

    Time frame: 4-week

    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.

  5. Motivation as Assessed by Readiness Ruler

    Time frame: 4-week

    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).

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

    Time frame: 4-week

    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.

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

    Time frame: 4-week

    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.

Other outcomes

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

    Time frame: 4-week

    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.

Sponsors and collaborators

Lead sponsor

Medical Decision Logic, Inc.

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • PRO Health Group

Registry information

Official study title

PROCare: Cloud Process Support for Opioid Recovery Participation and Learning

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2020
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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