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RAE (Realize, Analyze, Engage)

Sponsor
ContinueYou, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05227339
Collaborator
University of Massachusetts, Worcester (Other), University of Texas at Tyler (Other)
300
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: RAE
 Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
RAE (Realize, Analyze, Engage)- A Digital Biomarker Based Detection and Intervention System for Stress and Craving During Recovery From Substance Use Disorder: Phase II
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional (RAE + Usual Care)

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
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.
Other Names:
  • RAE Mobile App

    		•
    No Intervention: Control (Usual care)

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with return to drug use [3 months]

      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)

    Secondary Outcome Measures

    1. Number of participants retained in treatment [3 months]

      Participants status as engaged in recovery treatment (index treatment program or other)

    2. Number of hospitalizations and emergency department visits per participant [3 months]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Massachusetts Chan Medical School Worcester Massachusetts United States 01655

    Sponsors and Collaborators

    • ContinueYou, LLC
    • University of Massachusetts, Worcester
    • University of Texas at Tyler

    Investigators

    • Principal Investigator: Megan Reinhardt, ContinueYou, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    ContinueYou, LLC
    ClinicalTrials.gov Identifier:
    NCT05227339
    Other Study ID Numbers:
    • RAEPHASEII
    First Posted:
    Feb 7, 2022
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by ContinueYou, LLC
    mhealth
    stress
    craving
    wearables
    technology
    digital diagnostics
    digital health
    Additional relevant MeSH terms:
    Substance-Related Disorders

    Study Results

    No Results Posted as of Feb 11, 2022