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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DA051298-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| PRO Health Group | INDUSTRY |
| National Institute on Drug Abuse (NIDA) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROCare | Experimental | Technology-enabled, reward-based recovery platform |
|
| Control | No Intervention | Treatment-as-Usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-week |
| 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. | 4-week |
| Percentage of Participants Completing Outcomes Monitoring Surveys | Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation. | 4-week |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Using Opioids | Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period. | 4-week |
| Percentage of Participants Using Other Substances (Non-opioids) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L Proctor, PhD | PRO Health Group | Principal Investigator |
| Allen Tien, MD | Medical Decision Logic, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Florida Behavioral Health Network, Inc. | Miami | Florida | 33126 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Treatment-as-Usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PROCare Recovery | Technology-enabled, reward-based recovery mobile app |
| BG001 | Control | Treatment-as-Usual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 4-week |
|
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PROCare Recovery | Technology-enabled, reward-based recovery mobile app | 0 |
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Recruitment challenges due to COVID-19 pandemic (lower patient volumes/admissions, funding, staff shortages) leading to small numbers of participants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Proctor | PRO Health Group | 305-814-7762 | sproctor@prohealthgroup.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2022 | Oct 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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).
| 4-week |
| 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. | 4-week |
| 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. | 4-week |
| 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). | 4-week |
| 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. | 4-week |
| 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. | 4-week |
| 4-week |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Posted | Count of Participants | Participants | 4-week |
|
|
|
| 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. | Posted | Count of Participants | Participants | 4-week |
|
|
|
| Secondary | Percentage of Participants Using Opioids | Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period. | Posted | Count of Participants | Participants | 4-week |
|
|
|
| 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). | Posted | Count of Participants | Participants | 4-week |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 4-week |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 4-week |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 4-week |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 4-week |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 4-week |
|
|
|
| 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. | Only participants who used the PROCare Recovery app were administered the measure of app usability. | Posted | Mean | Standard Deviation | score on a scale | 4-week |
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|
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Control | Treatment-as-Usual | 0 | 4 | 0 | 4 | 0 | 4 |
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