Harnessing Digital Health to Understand Clinical Trajectories of Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Smartphone Sensor Data
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been active in Kaiser outpatient buprenorphine treatment for OUD for the past 2 weeks (determined at screening);
- •Be ≥18 years old (determined at screening);
- •Be able to understand English (determined at screening);
- •Be available to participate in the full duration of the study (12 weeks) (determined at screening);
- •Have an active email account and willing to provide the email address to researchers (determined at screening);
- •Permit researchers to access personal electronic health record (EHR) and medical claims data (determined at screening);
- •Be willing to carry and use personal or study provided smartphone for 12 weeks (determined at screening); and
- •Be willing to wear a smartwatch continuously (except during pre-defined activities such as showering) for 12 weeks (determined at screening).
排除标准
- •Are unwilling or unable to provide informed consent (determined during the Consent process and during Consent Quiz); and
- •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).
结局指标
主要结局
Smartphone Sensor Data
时间窗: 84 days (or 12-weeks)
The percentage of days carried the smartphone at least 8 hours per day.
次要结局
- Social Media Data(At baseline)
- The Number of Ecological Momentary Assessments (EMA) With Response(up to 3 times per day for 84 days (or 12-weeks))
- Smartwatch Sensor Data(84 days (or 12-weeks))
研究者
Lisa A. Marsch
Professor
Dartmouth-Hitchcock Medical Center