RAE (Realize, Analyze, Engage)

Study Overview
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Brief Summary
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The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder

Detailed Description
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RAE integrates digital detection of high-risk stress and craving periods by utilizing a mobile phone application and integrated wearable sensor. These detections are paired with interventions (mindfulness based de-escalation tools), support, and monitoring (to identify trends and plan for future). The present study will deploy the technology in a multi-site randomized controlled trial to test the efficacy of the RAE system in on clinical and psychosocial outcomes. Subjects will be randomized to use the RAE system (mobile app and wearable sensor) plus usual care vs usual care plus a fitness tracker only to measure differences retention in treatment, return to substance use, and overall psychosocial functioning. The ultimate goal is to develop a cost-effective, paradigm changing recovery tool that will improve substance use disorder treatment, and prevent related complications and deaths.

Official Title
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RAE (Realize, Analyze, Engage)- A Digital Biomarker Based Detection and Intervention System for Stress and Craving During Recovery From Substance Use Disorder: Phase II

Conditions
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Substance Use Disorders, Treatment Adherence and Compliance

Intervention / Treatment
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* Device: RAE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Enrolled in an outpatient SUD treatment program Enrolled in treatment for < 90 days Fluent in English Have access to a smartphone with iOS or Android Capabilities Capable of providing informed consent Exclusion Criteria: Pregnancy Prisoner Status Significant limitation of range of motion of non-dominant arm (amputation or fracture)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional (RAE + Usual Care)<br>Subjects will receive usual care through an outpatient substance use disorder treatment facility, will be provided with a wearable sensor and the RAE mobile application. Participants will be instructed to use the RAE app for a minimum of 30 days. | Device: RAE<br>* Subjects in the interventional group will have access to the RAE Health mobile app which receives continuous physiologic data from a wearable device. Algorithms embedded in the RAE app detect stress and craving events, and trigger mobile phone notifications when detected. Notifications are paired to real-time mindfulness based interventions.<br>* Other names: RAE Mobile App;|
| No Intervention: Control (Usual care)<br>Subjects will receive usual care through an outpatient substance use disorder treatment facility and will be provided with a wearable sensor (fitness tracker). They will not be given access to the RAE mobile app. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with return to drug use | Relapse to use of substance use defined as 1) self-reported use, 2) positive urine drug screen (from treatment program) or 3) provider report of confirmed relapse (Only applies to substances for which subject is receiving treatment) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants retained in treatment | Participants status as engaged in recovery treatment (index treatment program or other) | 3 months | 
| Number of hospitalizations and emergency department visits per participant | Includes absolute number of Emergency Department visits (SUD and non-SUD related), number of unplanned hospital admissions (SUD and non-SUD related), number of days hospitalized (SUD and non-SUD related admissions) and overdose related visits | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mhealth, stress, craving, wearables, technology, digital diagnostics, digital health