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

NCT06952491 — Enrolling by invitation, 1910 participants, Evidation Health
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RegistryNCT06952491, acronym RESHAPE
StatusEnrolling by invitation
Study typeObservational
Enrollment1910 (Estimated)
SponsorEvidation Health (Industry); collaborators: National Institute on Drug Abuse (NIDA)
ConditionsSubstance Use Disorder (SUD)
Datesstart 2025-04-22, primary completion 2027-12-01 (estimated), completion 2028-04-01 (estimated), first posted 2025-05-01, last updated 2026-10-16
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Substance Use Disorder (SUD)

-Summary

The goal of the RESHAPE study is to learn about the needs and experiences of adults who report having, or being at risk for, substance use disorder. The study will also evaluate engagement with an app-based program designed to support self-monitoring, goal setting, and well-being. The first part of the study will include adults who also report a health-related social need, such as food insecurity, housing instability, unreliable transportation, difficulty paying utility bills, or concerns about personal safety.

The main questions this study aims to answer are:

* What app features and educational resources do participants find useful?
* How do participants engage with study activities, resources, and opportunities to track their substance use and well-being?
* How do participants' reported well-being and substance use change over time?
* How do activity measures, such as physical activity, sleep, and heart rate, change over time among participants who connect a wearable activity tracker?
* How satisfied are participants with the RESHAPE program, and how willing are they to participate in future research?

The study has two parts. In Phase 1, 8 to 10 participants will complete a recorded, 60-minute online interview, and approximately 400 other participants will complete a one-time online survey. Researchers will use this information to refine the app-based program.

In Phase 2, participants will use the RESHAPE program for approximately one year. They will complete surveys and check-ins about substance use, cravings, well-being, goals, and social circumstances. Participants may also receive personalized graphs, educational resources, and insights based on study data. Those with a connected wearable activity tracker may share activity, sleep, and heart rate data. With their consent, information previously collected through the Evidation platform may also be linked with their study data.

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+Arms and interventions

ArmTypeInterventionsDescription
Participants with self-reported substance use disorder or at risk for substance use disorderParticipants from the Evidation platform with self-reported substance use disorder or at risk for substance use disorder.

+Outcome measures

Primary outcomes

  • Phase 1A: Willingness to participate in a future substance use disorder program [Baseline]: Number and percentage of interview and survey respondents reporting willingness to participate in a future substance use disorder program
  • Phase 1A: Perceived usefulness and expected use of a future program's potential features and content [Baseline]: Number and percentage of interview and survey respondents reporting that the future program's potential features are useful
  • Phase 1B: 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 [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
  • Phase 1B: 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 [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
  • Phase 1B: To quantify and describe real-world data from a connected wearable device previously collected on the Evidation platform [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
  • Phase 1B: To quantify and describe real-world data from responses to daily mood, stress, and sleep diaries previously collected on the Evidation platform [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
  • Phase 2: Monthly engagement with the RESHAPE Experience [Through 3 months, 6 months, and 12 months after Phase 2 enrollment]: Participant engagement will be assessed using the following monthly measures: (1) average number of in-app activities completed per participant, (2) average number of in-app activities dismissed per participant, and (3) average number of in-app impressions per participant.
  • Phase 2: Weekly completion of substance-use and well-being check-ins [3 months, 6 months, and 12 months after Phase 2 enrollment]: For each study week, the number and percentage of Phase 2 participants completing at least one substance-use check-in and the number and percentage completing at least one well-being check-in will be calculated. The average weekly percentages will be summarized across the Phase 2 study period.
  • Phase 2: Change from baseline in self-reported well-being [Through 3 months, 6 months, and 12 months after Phase 2 enrollment]: Change in self-reported well-being from baseline to 3 month, 6 months, and 12 months post enrollment.
  • Phase 2: Satisfaction with the RESHAPE Experience [Through 3 months, 6 months, and 12 months after Phase 2 enrollment]: Participant satisfaction with the RESHAPE Experience as measured by survey.
  • Phase 2: Willingness to participate in future research [Through 3 months, 6 months, and 12 months after Phase 2 enrollment]: Number and percentage of Phase 2 participants reporting willingness to participate in future research

Other outcomes

  • Phase 2: Change from baseline in self-reported substance-use frequency [Baseline, 3 months, 6 months, and 12 months after Phase 2 enrollment]: Change in self-reported substance-use frequency from baseline.
  • Phase 2: Change from baseline in intention to reduce or avoid substance use [Baseline, 3 months, 6 months, and 12 months after Phase 2 enrollment]: Change in self-reported intention to reduce or avoid substance use from baseline.
  • Phase 2: Change from baseline in self-efficacy to reduce or avoid substance use [Baseline, 3 months, 6 months, and 12 months after Phase 2 enrollment]: Change in self-reported self-efficacy to reduce or avoid substance use from baseline.
  • Phase 2: Change from baseline in wearable-derived physical activity [Baseline, 3 months, 6 months, and 12 months after Phase 2 enrollment]: Change in physical activity data collected from a connected wearable device.
  • Phase 2: Change from baseline in wearable-derived sleep [Baseline, 3 months, 6 months, and 12 months after Phase 2 enrollment]: Change in sleep data collected from a connected wearable device.
  • Phase 2: Change from baseline in wearable-derived heart rate [Baseline, 3 months, 6 months, and 12 months after Phase 2 enrollment]: Change in heart-rate data collected from a connected wearable device.

+Eligibility

Sex: All, ages: 21 Years to any

Phase 1A \& 1B 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)

Phase 2 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:
* monthly cannabis use in the past year or,
* monthly nicotine use in the past year, or
* drug use or medication use for nonmedical reasons at least 3 times in the past year

Exclusion Criteria

* Participation in Phase 1A (among Phase 1B participants), to be assessed using participation history
* There are no exclusion criteria for Phase 2

+Locations (1)

FacilityCityCountryStatus
Evidation HealthSan Mateo, CaliforniaUnited States

+Publications

  • Nevedal AL, Reardon CM, Opra Widerquist MA, Jackson GL, Cutrona SL, White BS, Damschroder LJ. Rapid versus traditional qualitative analysis using the Consolidated Framework for Implementation Research (CFIR). Implement Sci. 2021 Jul 2;16(1):67. doi: 10.1186/s13012-021-01111-5. PMID 34215286
  • Hennink MM, Kaiser BN, Marconi VC. Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough? Qual Health Res. 2017 Mar;27(4):591-608. doi: 10.1177/1049732316665344. Epub 2016 Sep 26. PMID 27670770
  • Kapteyn A, Angrisani M, Darling J, Gutsche T. The Understanding America Study (UAS). BMJ Open. 2024 Oct 23;14(10):e088183. doi: 10.1136/bmjopen-2024-088183. PMID 39448221
  • Shiffman S. Ecological momentary assessment (EMA) in studies of substance use. Psychol Assess. 2009 Dec;21(4):486-97. doi: 10.1037/a0017074. PMID 19947783
  • Chaturvedi RR, Angrisani M, Troxel WM, Gutsche T, Ortega E, Jain M, Boch A, Kapteyn A. American Life in Realtime: a benchmark registry of health data for equitable precision health. Nat Med. 2023 Feb;29(2):283-286. doi: 10.1038/s41591-022-02171-w. No abstract available. PMID 36737671
  • Cai M, Choi T, Xie Y, Al-Aly Z. Glucagon-like peptide-1 receptor agonists and risk of substance use disorders among US veterans with type 2 diabetes: cohort study. BMJ. 2026 Mar 4;392:e086886. doi: 10.1136/bmj-2025-086886. PMID 41781010
  • Saitz R, Cheng DM, Allensworth-Davies D, Winter MR, Smith PC. The ability of single screening questions for unhealthy alcohol and other drug use to identify substance dependence in primary care. J Stud Alcohol Drugs. 2014 Jan;75(1):153-7. doi: 10.15288/jsad.2014.75.153. PMID 24411807
  • Cucciare MA, Ounpraseuth ST, Curran GM, Booth BM. Predictors of mental health and substance use disorder treatment use over 3 years among rural adults using stimulants. Subst Abus. 2019;40(3):363-370. doi: 10.1080/08897077.2018.1547809. Epub 2019 Feb 27. PMID 30810499
  • Kerridge BT, Pickering RP, Saha TD, Ruan WJ, Chou SP, Zhang H, Jung J, Hasin DS. Prevalence, sociodemographic correlates and DSM-5 substance use disorders and other psychiatric disorders among sexual minorities in the United States. Drug Alcohol Depend. 2017 Jan 1;170:82-92. doi: 10.1016/j.drugalcdep.2016.10.038. Epub 2016 Nov 7. PMID 27883948
  • Schuler MS, Rice CE, Evans-Polce RJ, Collins RL. Disparities in substance use behaviors and disorders among adult sexual minorities by age, gender, and sexual identity. Drug Alcohol Depend. 2018 Aug 1;189:139-146. doi: 10.1016/j.drugalcdep.2018.05.008. Epub 2018 Jun 19. PMID 29944989
  • Paschen-Wolff MM, DeSousa A, Paine EA, Hughes TL, Campbell ANC. Experiences of and recommendations for LGBTQ+-affirming substance use services: an exploratory qualitative descriptive study with LGBTQ+ people who use opioids and other drugs. Subst Abuse Treat Prev Policy. 2024 Jan 3;19(1):2. doi: 10.1186/s13011-023-00581-8. PMID 38172902
  • Patrick SW, Richards MR, Dupont WD, McNeer E, Buntin MB, Martin PR, Davis MM, Davis CS, Hartmann KE, Leech AA, Lovell KS, Stein BD, Cooper WO. Association of Pregnancy and Insurance Status With Treatment Access for Opioid Use Disorder. JAMA Netw Open. 2020 Aug 3;3(8):e2013456. doi: 10.1001/jamanetworkopen.2020.13456. PMID 32797175
  • 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

+Investigators

+Funding

NIH grants: R44DA062284