Mobile Platform for Optimizing Wellness and Engagement in Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility based on recruitment
研究概览
简要总结
This pilot study addresses the urgent public health crisis of co-occurring opioid and alcohol use disorders (OUD-AUD), leading causes of mortality in the United States, by testing a scalable digital contingency management (CM) treatment among Medicaid beneficiaries. The study aims to evaluate the feasibility and acceptability of digital CM for OUD-AUD recovery, while also planning for broader implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be enrolled in the Michigan Medicaid program
- •Opioid agonist treatment (OAT): Participants must have initiated OAT with buprenorphine or methadone
- •Participants must have an OAT prescription and Alcohol use disorder (AUD) based on self-report measure during screening
- •Participants must have regular access to a working smartphone and internet connection.
- •Participants must have a reliable mailing address to receive study supplies (e.g., salivary drug tests).
排除标准
- •Primary Medicare Coverage: Individuals that are dual-eligible for Medicaid and Medicare and aged 65 or older, due to limited availability of Medicaid claims data for this group
- •Individuals that cannot voluntarily provide informed consent themselves for any reason, including legal incompetency
- •Individuals with substantial cognitive impairment that would interfere with study participation
- •Individuals unable to read or understand English
- •Individuals experiencing active suicidality or psychosis.
- •Individuals with a planned admission to residential treatment or incarceration during the study period.
研究组 & 干预措施
Wellness Condition
After participants meet eligibility and complete the DynamiCare assessment period, those randomized to this group will receive a wellness digital platform that includes surveys, testing, and tech support.
干预措施: Digital Wellness Arm (Behavioral)
Digital Contingency Management (CM) Intervention Arm
After participants meet eligibility and complete the DynamiCare assessment period, participants randomized to this group will receive a comprehensive digital CM platform designed to enhance OAT retention and promote abstinence from alcohol and opioids. This will include the DynamiCare Motivation Support Program.
干预措施: Digital Contingency Management Intervention Arm (Behavioral)
结局指标
主要结局
Feasibility based on recruitment
时间窗: Recruitment period 12 months
Recruitment: ≥60% of participants enrolled
Feasibility based on adherence
时间窗: 6 months (during the Dynamicare program)
Adherence: ≥50% of app-based, biochemically-verified tests completed in the digital CM condition.
Feasibility based on Retention
时间窗: 6 months
Retention: ≥70% of participants retained at 6 months
Acceptability of the intervention
时间窗: 3-month after starting program
Defined as \>70% of participants rating the intervention experience ≥ 4/5 on the Acceptability of Intervention Measure
次要结局
未报告次要终点
研究者
Lara Coughlin
Associate Professor of Psychiatry
University of Michigan