Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder

Opioid-use Disorder Clinical Trial

— D-TECT  

Official title:

Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535583
• Other study ID #: CTN-0084-A2
• Secondary ID: UG1DA040309UG1DA
• Status: Completed
• Start date: July 23, 2020
• Est. completion date: September 21, 2021

Study information

• Verified date: November 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 21, 2021
• Est. primary completion date: June 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California, Division of Research	Oakland	California

Sponsors (5)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College, Kaiser Permanente, National Drug Abuse Treatment Clinical Trials Network, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smartphone Sensor Data	The percentage of days carried the smartphone at least 8 hours per day.	84 days (or 12-weeks)
Secondary	Social Media Data	The percentage of participants who consented to download social media data.	At baseline
Secondary	The Number of Ecological Momentary Assessments (EMA) With Response	The response rate to Ecological Momentary Assessment prompts during the 12-week study phase. The EMA Response Rate for each participant is the number of EMAs responded to over the last 83 days of the study (up to 249 responses [83 days X 3 EMA]) (yields a percentage). The total mean EMA response rate was based on the EMA response rate (percentage) across all participants in the study (N=62).	up to 3 times per day for 84 days (or 12-weeks)
Secondary	Smartwatch Sensor Data	The percentage of days wore the smartwatch at least 18 hours per day.	84 days (or 12-weeks)