Opioid-use Disorder
Conditions
Keywords
Opioid Use Disorder, Digital Health, Substance Use Disorder, Social Media
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.
Interventions
None listed
Sponsors
National Drug Abuse Treatment Clinical Trials Network
Dartmouth College
Kaiser Permanente
National Institute on Drug Abuse (NIDA)
Dartmouth-Hitchcock Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smartphone Sensor Data | 84 days (or 12-weeks) | The percentage of days carried the smartphone at least 8 hours per day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Media Data | At baseline | The percentage of participants who consented to download social media data. |
| The Number of Ecological Momentary Assessments (EMA) With Response | up to 3 times per day for 84 days (or 12-weeks) | 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). |
| Smartwatch Sensor Data | 84 days (or 12-weeks) | The percentage of days wore the smartwatch at least 18 hours per day. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EMA Plus Passive Sensing (Social Media Optional) 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. Participation in the social media data collection portion of the study was optional. Participants with social media accounts could consent to share their social media data with the study team. | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | EMA Plus Passive Sensing (Social Media Optional) |
|---|---|
| Age, Continuous | 37.2 years STANDARD_DEVIATION 13.3 |
| Race/Ethnicity, Customized Hispanic/Latino/of Spanish origin | 14 participants |
| Race/Ethnicity, Customized Non-Hispanic | 51 participants |
| Race/Ethnicity, Customized Non-white/more than one race | 19 participants |
| Race/Ethnicity, Customized White | 46 participants |
| Region of Enrollment United States | 65 participants |
| Sex/Gender, Customized Female | 31 participants |
| Sex/Gender, Customized Male | 32 participants |
| Sex/Gender, Customized Other | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 65 |
| other Total, other adverse events | 5 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
Smartphone Sensor Data
The percentage of days carried the smartphone at least 8 hours per day.
Time frame: 84 days (or 12-weeks)
Population: 62 out of the 65 participants completed the baseline visit and received the study smartphone or had the study app setup on their personal smartphone to contribute passive data via smartphone.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EMA Plus Passive Sensing (Social Media Optional) | Smartphone Sensor Data | 94.2 mean percentage of days |
Secondary
Smartwatch Sensor Data
The percentage of days wore the smartwatch at least 18 hours per day.
Time frame: 84 days (or 12-weeks)
Population: 62 out of the 65 participants completed the baseline visit and received the study smartwatch to contribute passive data via smartwatch.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EMA Plus Passive Sensing (Social Media Optional) | Smartwatch Sensor Data | 73.7 Mean percentage of days |
Secondary
Social Media Data
The percentage of participants who consented to download social media data.
Time frame: At baseline
Population: 49 out of 56 participants had social media accounts. Therefore, the denominator used to determine the percentage of participants who consented to download social media data was the total number of participants with social media accounts.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EMA Plus Passive Sensing (Social Media Optional) | Social Media Data | 49 Participants |
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).
Time frame: up to 3 times per day for 84 days (or 12-weeks)
Population: 62 out of the 65 participants completed the baseline visit and received the study smartphone or had the study app setup on their personal smartphone to respond to ecological momentary assessments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EMA Plus Passive Sensing (Social Media Optional) | The Number of Ecological Momentary Assessments (EMA) With Response | 70.0 mean percentage of EMA response rate |