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Clinical Trials/NCT06952491
NCT06952491Enrolling By InvitationNot Applicable

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

Evidation Health1 site in 1 country410 target enrollmentStarted: April 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
410
Locations
1
Primary Endpoint
Willingness to participate in a future substance use disorder program

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Evidation Health
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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