Clinical trial NCT06952491: Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacy
Official title: Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Substance Use Disorder (SUD)
Keywords: Substance abuse
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-01
Enrollment: 410
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: United States residents

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.


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

Primary outcomes:
measure: Willingness to participate in a future substance use disorder program
timeFrame: Baseline
measure: Perceived usefulness and expected use of a future program's potential features and content
timeFrame: Baseline
measure: 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
measure: 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
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
affiliation: Evidation Health
name: Christian Cerrada, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.