By InvitationNot Applicable

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

United States410 participantsStarted 2025-04

Plain-language summary

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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Willingness to participate in a future substance use disorder program

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: From approximately 1 year prior to enrollment until study enrollment

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

Timeframe: Baseline

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

Timeframe: From approximately 1 year prior to enrollment until study enrollment

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

Timeframe: From approximately 1 year prior to enrollment until study enrollment

Trial details

NCT IDNCT06952491

SponsorEvidation Health

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05

View on ClinicalTrials.gov More Substance Use Disorder (SUD) trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Willingness to participate in a future substance use disorder program

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: From approximately 1 year prior to enrollment until study enrollment

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

Timeframe: Baseline

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

Timeframe: From approximately 1 year prior to enrollment until study enrollment

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

Timeframe: From approximately 1 year prior to enrollment until study enrollment