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

NCT06952491 | Enrolling By Invitation

• 2 other identifiers: Pro000852941R44DA062284-01
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use Disorder (SUD)

Keywords

Substance abuse

Outcome Measures

Primary Outcomes (6)

• Willingness to participate in a future substance use disorder program

  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

  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

  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

  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

  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

  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

Study Arms (1)

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

United States residents

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Evidation Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Evidation Health

San Mateo, California, 94402, United States

Location

Related Publications (2)

• Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018 Oct 8;8(10):e019993. doi: 10.1136/bmjopen-2017-019993.

  PMID: 30297341 BACKGROUND

• Schuler MS, Prince DM, Collins RL. Disparities in Social and Economic Determinants of Health by Sexual Identity, Gender, and Age: Results from the 2015-2018 National Survey on Drug Use and Health. LGBT Health. 2021 Jul;8(5):330-339. doi: 10.1089/lgbt.2020.0390. Epub 2021 Jun 8.

  PMID: 34101498 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Christian Cerrada, PhD

  Evidation Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 1, 2025
• Study Start: April 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)