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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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Randomized pilot study of a device (smartphone app) that poses non-significant risk to participants and is exempt from Investigational Device Exemption regulations [21 Code of Federal Regulations 812.2(c)](streamdown:incomplete-link)
To test the feasibility/acceptability and efficacy of a minimum viable product (MVP) of a smartphone app for patients with alcohol use disorder who are in active treatment and recovery to perform self-tracking of their recovery behavior (e.g., abstinence) and focus on their motivation to maintain their desired health behaviors (i.e., abstinence).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DynamiCare Rewards | Experimental | The study will test the feasibility/acceptability and efficacy of DynamiCare Rewardsâ„¢. DynamiCare Rewards is an iOS/Android app which automates Contingency Management (CM) to help the patient self-monitor and focus attention on his/her behavioral goals (i.e., abstinence) for alcohol or other substance use disorders. |
|
| Control | No Intervention | Treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DynamiCare Rewards | Behavioral | Participants assigned to the DynamiCare Rewards group will receive the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants abstinent from alcohol at each monthly assessment time point (negative urine test and self-report of no use in past 30 days) | The pilot efficacy study will utilize alcohol abstinence at each assessment time point as the primary outcome. This is defined as a negative ethyl glucuronide urine test (witnessed) at the monthly assessment time points and self-report of no alcohol use in the past 30 days. | 12-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants abstinent from all drugs at each monthly assessment time point (negative urine test and self-report of no use in past 30 days) | Groups will be compared using Generalized Estimating Equation (GEE) analysis on the percent of participants abstinent over time at each time point. | 12-week intervention period |
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Inclusion Criteria:
Participants in the pilot study will be 60 new intakes to Gosnold's outpatient Substance Use Disorder (SUD) program who:
Exclusion Criteria:
• Participants must not currently be suicidal or actively psychotic, by clinician judgement.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Gastfriend, MBA | DynamiCare Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gosnold on Cape Cod | Centerville | Massachusetts | 02632 | United States | ||
| Gosnold |
We intend to make participant data available by request as long as it is unidentifiable.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| Longest continuous period of abstinence from alcohol and from drugs and alcohol |
Groups will be compared using GEE analysis on the percent of participants abstinent over time at each time point. |
| 12-week intervention period |
| Retention in treatment | Groups will be compared on the number of days retained in treatment according to the site's Electronic Health Record data, and also on the graduation rate from treatment vs. leaving against medical advice. | 12-week intervention period |
| Falmouth |
| Massachusetts |
| 02540 |
| United States |