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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)