Clinical trial NCT04535583: Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder
Official title: Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Keywords: Opioid Use Disorder
Digital Health
Substance Use Disorder
Social Media
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Drug Abuse Treatment Clinical Trials Network
name: Dartmouth College
name: Kaiser Permanente
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-09-02
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is recruiting individual who are active in medication treatment for opioid use disorder (MOUD) with buprenorphine for at least 2 weeks.

Brief 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.

Detailed description: This is an observational study designed to (1) evaluate the feasibility and utility of digital health technology in a Medication for Opioid Use Disorder (MOUD) treatment population, and (2) capitalize on the availability of Electronic Health Record (EHR) data to relate passive and active sensing data to treatment retention and medication adherence.

Eligible participants are identified through EHR records, sent an invitational letter through secure message, and then called to recruit and screen. Following verbal consent to screen, research staff will perform a screening assessment over the phone/video to determine preliminary study eligibility prior to scheduling the baseline phone/video appointments. Following electronic signed informed consent, participants will be asked to complete an interviewer administered Baseline assessment. In addition to the screening and baseline assessments, the participants will be asked to wear a smartwatch and carry a smartphone continuously for a period of 12 weeks. Smartphone and smartwatch data will be passively collected. In addition, participants will be prompted to respond to questions through a smartphone (i.e., Ecological Momentary Assessment (EMA)) 3 times daily for 12 weeks. In addition to the EMA prompts, individuals will be asked to self-initiate EMAs if substance use occurred.

After the 12-week active study phase, participants will be asked to complete a follow-up phone/video appointment.

EHR and medical claims data will be extracted 16 weeks after study completion (data will be collected 12 months prior to EMA start through 12 weeks after EMA start).

For those who consent to the optional social media component, social media data will be downloaded by the participant directly from the social media platform to a secure server using a remote desktop at the beginning of the study and at the end of the study.

Eligibility criteria: Inclusion Criteria:

1. Have been active in Kaiser outpatient buprenorphine treatment for OUD for the past 2 weeks (determined at screening);
2. Be ≥18 years old (determined at screening);
3. Be able to understand English (determined at screening);
4. Be available to participate in the full duration of the study (12 weeks) (determined at screening);
5. Have an active email account and willing to provide the email address to researchers (determined at screening);
6. Permit researchers to access personal electronic health record (EHR) and medical claims data (determined at screening);
7. Be willing to carry and use personal or study provided smartphone for 12 weeks (determined at screening); and
8. Be willing to wear a smartwatch continuously (except during pre-defined activities such as showering) for 12 weeks (determined at screening).

Exclusion Criteria:

1. Are unwilling or unable to provide informed consent (determined during the Consent process and during Consent Quiz); and
2. 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).

Primary outcomes:
measure: Smartphone Sensor Data
timeFrame: 84 days (or 12-weeks)
Secondary outcomes:
measure: Social Media Data
timeFrame: At baseline
measure: The Number of Ecological Momentary Assessments (EMA) With Response
timeFrame: up to 3 times per day for 84 days (or 12-weeks)
measure: Smartwatch Sensor Data
timeFrame: 84 days (or 12-weeks)
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California, Division of Research
state: California
Study officials:
affiliation: Dartmouth College
name: Lisa A Marsch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Cynthia Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marsch LA, Chen CH, Adams SR, Asyyed A, Does MB, Hassanpour S, Hichborn E, Jackson-Morris M, Jacobson NC, Jones HK, Kotz D, Lambert-Harris CA, Li Z, McLeman B, Mishra V, Stanger C, Subramaniam G, Wu W, Campbell CI. The Feasibility and Utility of Harnessing Digital Health to Understand Clinical Trajectories in Medication Treatment for Opioid Use Disorder: D-TECT Study Design and Methodological Considerations. Front Psychiatry. 2022 Apr 29;13:871916. doi: 10.3389/fpsyt.2022.871916. eCollection 2022.