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OpenTrials
Enrolling by Invitation

NCT Number: NCT06952491

Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacy

The goal of this study is to gather feedback on a potential program that collects and shares real-world information to help create products and services to support people who have substance use disorders.

Enrolling by Invitation

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Key information

Conditions

Substance Use Disorder (SUD) Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evidation Health

San Mateo, California, 94402, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • U.S. resident
  • Speaks, read, and understands English
  • Adults ≥ 21 years of age
  • Self-reported substance use disorder or at risk for substance use disorder as defined by cannabis use, tobacco use, illegal drug use, or prescription medication use for nonmedical reasons on at least 2-3 times in the past year
  • Self-reports at least one of the following health-related social needs as assessed by American Academy of Family Physicians Social Needs

Screening Tool:

  • Housing instability
  • Non-reliable transportation
  • Food insecurity
  • Utility needs
  • Personal safety
  • Willingness and availability to participate in a recorded online interview (Phase 1A participants)

Exclusion criteria

  • Participation in Phase 1A (among Phase 1B participants), to be assessed using participation history

Treatment and study plan

Primary outcomes

  1. Willingness to participate in a future substance use disorder program

    Time frame: Baseline

    Number and percentage of interview and survey respondents reporting willingness to participate in a future substance use disorder program

  2. Perceived usefulness and expected use of a future program's potential features and content

    Time frame: Baseline

    Number and percentage of interview and survey respondents reporting that the future program's potential features are useful

  3. To quantify and describe real-world health related social needs and/or substance use and/or demographics survey(s) previously collected on the Evidation platform

    Time frame: From approximately 1 year prior to enrollment until study enrollment

    Number and percentage of interview and survey respondents who completed at least one health related social needs and/or substance use and/or demographics survey on the Evidation platform in the past year

  4. Perceived expected use of potential features and content to be included in a program to improve well-being and self-efficacy for health promoting activities

    Time frame: Baseline

    Number and percentage of interview and survey respondents reporting that they expect to use each of the future program's potential features and content

  5. To quantify and describe real-world data from a connected wearable device previously collected on the Evidation platform

    Time frame: From approximately 1 year prior to enrollment until study enrollment

    Average number of days with valid steps, sleep, and heart rate data from a connected wearable device in the past year

  6. To quantify and describe real-world data from responses to daily mood, stress, and sleep diaries previously collected on the Evidation platform

    Time frame: From approximately 1 year prior to enrollment until study enrollment

    Average number of days with responses to daily mood, stress, and sleep diaries in the past year

Sponsors and collaborators

Lead sponsor

Evidation Health

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: RESHAPE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

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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