NCT07451197尚未招募不适用
Family-focused Digital Intervention for MOUD Initiation and Retention
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 338
- 试验地点
- 2
- 主要终点
- Initiation of MOUD
研究概览
简要总结
The purpose of this clinical trial is to develop and test whether a text- and web-based tool called FamilyCHESS - designed for individuals with opioid use disorder (OUD) and a concerned significant other (CSO) - can help the identified patient (IP) begin and stay on medication for opioid use disorder (MOUD).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 18 years or older who meet the criteria for moderate or severe opioid use disorder (OUD) as determined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Referred to as the "Identified Patient" or IP.
- •Be a parent, spouse or committed romantic partner, other family member, or friend, age 21 or older, of the individual with OUD. Referred to as "Concerned Significant Other" or CSO.
- •Able to communicate fluently in English.
- •Own a smartphone.
排除标准
- •IP must not have been on MOUD in the last 2 weeks.
- •CSO must not meet criteria for any severity of substance use disorder (SUD), except tobacco use.
研究组 & 干预措施
FamilyCHESS (Family Comprehensive Health Enhancement Support System)
Experimental
Participant dyads will receive FamilyCHESS
干预措施: FamilyCHESS (Behavioral)
Control
Active Comparator
Participant dyads will receive standard of care treatment for MOUD
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
Initiation of MOUD
时间窗: 12 months
Number of days between study start date and MOUD initiation date.
Continuity on MOUD
时间窗: 4, 8, and 12 months
Collected through self-report. Percentage of days IPs in the intervention arm are on MOUD compared to control arm.
次要结局
- Change in IP Quality of Life(Baseline, 4, 8, and 12 months)
- Change in number of opioid overdoses(Baseline, 4, 8, and 12 months)
- Change in number of emergency room visits(Baseline to 12 months)
- Change in percentage of days of opioid use(Baseline, 4, 8, and 12 months)
- Change in McMaster Family Functioning Scale (FAD-GF)(Baseline, 4, 8, and 12 months)
- Change in CSO coping styles(Baseline, 4, 8, and 12 months)
- Change in CSO perceptions of social support(Baseline, 4, 8, and 12 months)
- Change in CSO Quality of Life(Baseline, 4, 8, and 12 months)
研究者
研究点 (2)
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