Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UG1DA040309 | U.S. NIH Grant/Contract | View source | |
| UG1DA040314 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Drug Abuse Treatment Clinical Trials Network | NETWORK |
| Dartmouth College | OTHER |
| Kaiser Permanente | OTHER |
| National Institute on Drug Abuse (NIDA) |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMA plus passive sensing | 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Smartphone Sensor Data | The percentage of days carried the smartphone at least 8 hours per day. | 84 days (or 12-weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Social Media Data | The percentage of participants who consented to download social media data. | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
This study is recruiting individual who are active in medication treatment for opioid use disorder (MOUD) with buprenorphine for at least 2 weeks.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa A Marsch, PhD | Dartmouth College | Principal Investigator |
| Cynthia Campbell, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California, Division of Research | Oakland | California | 94612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35573377 | Derived | 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. |
Not provided
Not provided
A de-identified dataset will be made available by the Principal Investigators upon request.
Data will be available after the completion of the study and data lock.
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.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smartphone Sensor Data | The percentage of days carried the smartphone at least 8 hours per day. | 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. | Posted | Mean | 95% Confidence Interval | mean percentage of days | 84 days (or 12-weeks) |
|
11 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa A. Marsch | Geisel School of Medicine at Dartmouth | 603-646-7092 | lisa.a.marsch@dartmouth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2020 | Jul 25, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| NIH |
Not provided
Not provided
Not provided
| 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. | 84 days (or 12-weeks) |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Social Media Data | The percentage of participants who consented to download social media data. | 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. | Posted | Count of Participants | Participants | 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). | 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. | Posted | Mean | 95% Confidence Interval | mean percentage of EMA response rate | 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. | 62 out of the 65 participants completed the baseline visit and received the study smartwatch to contribute passive data via smartwatch. | Posted | Mean | 95% Confidence Interval | Mean percentage of days | 84 days (or 12-weeks) |
|
|
|
| 1 |
| 65 |
| 0 |
| 65 |
| 5 |
| 65 |
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided