Enrolling by invitation NCT06952491
Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Substance Use Disorder (SUD). Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Willingness to participate in a future substance use disorder program [Time frame: Baseline]
- Perceived usefulness and expected use of a future program's potential features and content [Time frame: 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]
- 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]
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Evidation Health — San Mateo
Publications
- 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
- 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
Identifiers
NCT: NCT06952491 · Pro00085294 · 1R44DA062284-01