Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of MAIN-ART Tool as Measured by Recruitment Rates
研究概览
简要总结
The purpose of the study is to determine if providing participants with alcohol-related liver disease with tailored alcohol use treatment options is feasible and acceptable in order to increase their engagement with treatment and reduce alcohol use. This is an important area to study to help create ways to increase participants' knowledge about different treatment options as well as increase likelihood of seeking and participating in alcohol use disorder treatments.
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
- Single (Investigator)
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
- •Enrolled at University of Michigan general hepatology clinics or inpatient wards
- •Documented diagnosis of alcohol-associated cirrhosis or alcoholic hepatitis or alcohol-related liver disease of any stage
- •Drinking of any amount of alcohol within the 6 months prior to recruitment
- •No alcohol use treatment within the past 1 month
- •Access to a phone for purposes of follow-up
排除标准
- •Active alcohol use treatment
- •Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation.
- •Is enrolled in the multidisciplinary alcohol-related liver disease clinic at Michigan Medicine
结局指标
主要结局
Feasibility of MAIN-ART Tool as Measured by Recruitment Rates
时间窗: Up to 6 months
Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Study recruitment started on 23 September, 2020 and concluded on 10 January 2022. The results reflect the number and percent of those patients who were approached, were determined to be eligible, and were consented.
Feasibility of MAIN-ART Tool as Measured by Retention Rates
时间窗: Up to 6 months
Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Retention rate is shown by the number of participants who continued in the study for 6 months, and the percentage that it represents compared to those who began it but did not follow through to the end of the study (6 months).
Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys
时间窗: Up to 1 hour
On the day the participants engage with the MAIN-ART tool, acceptability will be determined by patient-level surveys. The System usability Survey (SUS) consists of 10 questions ranging from 1 (strongly disagree) to 5 (strongly agree). A scoring algorithm which produces a range from 0 to 100 was used. Current literature suggests that a score above 68 for mean SUS is considered "above average." By "intervention," this measure means interaction with the MAIN-ART tool, which occurs only at the participant's initial visit.
次要结局
- Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview(Baseline and 6 months)
- Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.(Up to 6 months)
研究者
Jessica Mellinger
Assistant Professor of Internal Medicine
University of Michigan