An observational study in Opioid-use Disorder, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-15.
Sponsored by Dartmouth-Hitchcock Medical Center · Observational
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.
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.
1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.
This study's enrollment of 65 is below the median of 129 across 175 observational studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 486 studies on the registry; 69 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study is recruiting individual who are active in medication treatment for opioid use disorder (MOUD) with buprenorphine for at least 2 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will be responding to up to 3 ecological momentary assessments per day plus carrying a smartphone and wearing a smartwatch. Both the smartphone and smartwatch will passively collect sensor data continuously.
Smartphone Sensor Data
The percentage of days carried the smartphone at least 8 hours per day.
Time frame: 84 days (or 12-weeks)
Social Media Data
The percentage of participants who consented to download social media data.
Time frame: At baseline
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).
Time frame: up to 3 times per day for 84 days (or 12-weeks)
Smartwatch Sensor Data
The percentage of days wore the smartwatch at least 18 hours per day.
Time frame: 84 days (or 12-weeks)
| Milestone | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| Started | 65 |
| Completed | 62 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 1 |
The percentage of days carried the smartphone at least 8 hours per day.
| mean percentage of days | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| Smartphone Sensor Data | 94.2 (90.8 to 97.6) |
The percentage of participants who consented to download social media data.
| Participants | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| Social Media Data | 49 |
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).
| mean percentage of EMA response rate | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| The Number of Ecological Momentary Assessments (EMA) With Response | 70.0 (63.5 to 81.4) |
The percentage of days wore the smartwatch at least 18 hours per day.
| Mean percentage of days | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| Smartwatch Sensor Data | 73.7 (67.7 to 79.7) |
Collected over 11 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EMA Plus Passive Sensing (Social Media Optional) | 1/65 (1.5%) | 0/65 (0%) | 5/65 (7.7%) |
| Event | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| RashSkin and subcutaneous tissue disorders | 3/65 |
| Suicidal IdeationPsychiatric disorders | 2/65 |
| Age, Continuous(years) | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| Mean | 37.2 ± 13.3 |
| Sex/Gender, Customized(participants) | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| Male | 32 |
| Female | 31 |
| Other | 2 |
| Race/Ethnicity, Customized(participants) | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| White | 46 |
| Non-white/more than one race | 19 |
| Hispanic/Latino/of Spanish origin | 14 |
| Non-Hispanic | 51 |
| Region of Enrollment(participants) | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| United States | 65 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A de-identified dataset will be made available by the Principal Investigators upon request.
Supporting information: Study protocol
Time frame: Data will be available after the completion of the study and data lock.
Access criteria: Prior to receiving any study data, researchers/institutions will need to enter into a data sharing agreement with the institution(s) providing the de-identified study data.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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