N/A
N=65
Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04535583 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Smartphone Sensor Data — 94.2 mean percentage of days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smartphone Sensor Data |
94.2 | — |
| SECONDARY Social Media Data |
49 | — |
| SECONDARY The Number of Ecological Momentary Assessments (EMA) With Response |
70.0 | — |
| SECONDARY Smartwatch Sensor Data |
73.7 | — |
Summary
The main objective of the study is to evaluate the feasibility of utilizing digital health technology with opioid use disorder (OUD) patients as measured by a 12-week period of continuous assessment using smartphone surveys and digital sensing. In addition, we will examine the utility of 3 types of digital data (Ecological Momentary Assessment (EMA); Digital sensing; and social media data) in predicting OUD treatment retention and buprenorphine medication adherence.
Eligibility Criteria
Inclusion Criteria
- Have been active in Kaiser outpatient buprenorphine treatment for OUD for the past 2 weeks (determined at screening);
- Be ≥18 years old (determined at screening);
- Be able to understand English (determined at screening);
- Be available to participate in the full duration of the study (12 weeks) (determined at screening);
- Have an active email account and willing to provide the email address to researchers (determined at screening);
- Permit researchers to access personal electronic health record (EHR) and medical claims data (determined at screening);
- Be willing to carry and use personal or study provided smartphone for 12 weeks (determined at screening); and
- Be willing to wear a smartwatch continuously (except during pre-defined activities such as showering) for 12 weeks (determined at screening).
Exclusion Criteria
- Are unwilling or unable to provide informed consent (determined during the Consent process and during Consent Quiz); and
- Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities (determined by Prisoner Status Assessment at each study visit).
Data sourced from ClinicalTrials.gov (NCT04535583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.