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

April 28, 2025 updated by: Evidation Health
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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

410

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Mateo, California, United States, 94402
        • Evidation Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

United States residents

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants with self-reported substance use disorder or at risk for substance use disorder

Participants from the Evidation platform with 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
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
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
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
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
Baseline
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
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
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
From approximately 1 year prior to enrollment until study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidation Health

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Christian Cerrada, PhD, Evidation Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00085294
  • 1R44DA062284-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Substance Use Disorder (SUD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe