Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease (IMPACT-ALD): Aim 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 298
- 试验地点
- 6
- 主要终点
- Days of Alcohol Abstinence in ALD Participants
研究概览
简要总结
This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.
详细描述
The goal of this project is to implement and evaluate an evidence-based mHealth system to help patients diagnosed with ALD with alcohol cessation. Connections is a mobile health app developed by CHESS Health to support patients with alcohol use disorders. Patients will be enrolled in both general hepatology and multidisciplinary ALD clinics (which include integrated alcohol use treatment professionals alongside hepatology providers) at two large tertiary care centers (University of Wisconsin (UW) and University of Michigan (UM)). The hypothesis is that the implementation of an adapted version of Connections for patients with ALD will improve rates of alcohol cessation and improve liver function.
- Aim 1 (described in this record) will assess the effectiveness of the Connections app plus usual care (n=149) compared to usual care (n=149) on days of alcohol abstinence over 6 months.
- Aim 2: Assess the implementability of the Connections app in the ALD population using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) to determine facilitators and barriers to the successful adoption of the app at the patient, provider, and clinic levels.
Secondary analyses will examine use of the Connections app on health outcomes (including depression, anxiety, insomnia, liver health, and quality of life) and health behaviors (including engagement with alcohol use disorder (AUD) and/or ALD treatments and ongoing alcohol use). Key moderators (including age, sex, race, ethnicity, marital status, rurality, and ALD severity) and mediators (including relatedness, competence, autonomous motivation) on outcomes will be explored. The impact of the Connections app on measures of chronic liver impairment documented in the health record will be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Diagnosis of ALD (any stage)
- •Alcoholic liver disease (ALD) encompasses a spectrum of hepatic injuries caused by long-term alcohol abuse. For this study, participants will have a diagnosis of ALD or evidence of the combination of liver disease and alcohol misuse in electronic health record.
- •Alcohol use within the last 6 months
- •Receiving care at UW or Henry Ford Health + MSU
- •Either the general hepatology clinic or the multidisciplinary ALD clinic
- •Able to read and write proficiently in English
- •Willing and able to use a smartphone app
排除标准
- •Actively listed for liver transplant or history of liver transplant before being enrolled in the study. Participants added to a liver transplant list after being enrolled in the study will be allowed to continue their participation
- •In hospice care
- •Has severe cognitive impairment (as described in electronic health record including dementia, delirium, and/or unable to maintain cognitive alertness during screening--as determined by study staff.)
研究组 & 干预措施
Treatment as Usual
Connections App
The Connections app is based on principles of effective care for substance use disorders, such as sustained duration, peer support, improving coping skills in high-risk situations, assertive outreach, self- monitoring, prompts, and action planning. The theoretical foundation of CHESS Health is self-determination theory, which holds that an individual's adaptive functioning can be improved if the patient feels (1) competent, (2) related to others, and (3) internally motivated rather than coerced in one's actions.
干预措施: Connections App (Device)
结局指标
主要结局
Days of Alcohol Abstinence in ALD Participants
时间窗: data collected monthly, up to 6 months
Alcohol consumption outcomes will be collected monthly and include whether or not alcohol was consumed on each of the past 30 days. Alcohol consumption outcomes will be compared between the usual care condition and the usual care plus the Connections app condition.
Number of Standard Drinks Consumed in ALD Participants
时间窗: data collected monthly, up to 6 months
Alcohol consumption outcomes will be collected monthly and include whether or not alcohol was consumed on each of the past 30 days, if yes, participant's will also be asked the number of standard drinks for each day alcohol was consumed. Alcohol consumption outcomes will be compared between the usual care condition and the usual care plus the Connections app condition.
次要结局
- Change in Patient Health Questionnaire (PHQ-8) Score(baseline, 3 months, 6 months)
- Change in Generalized Anxiety Disorder (GAD-7) Score(baseline, 3 months, 6 months)
- Change in Pain Interference (PEG) Score(baseline, 3 months, 6 months)
- Change in Insomnia Severity Index (ISI) Score(baseline, 3 months, 6 months)
- Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score(baseline, 3 months, 6 months)
- Change in PROMIS Global Health Score(baseline, 3 months, 6 months)
- Change in CHESS Bonding Scale Score(baseline, 3 months, 6 months)
- Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score(baseline, 3 months, 6 months)
- Change in Treatment Self-Regulation Questionnaire (TSRQ) Score(baseline, 3 months, 6 months)
- Alcohol Use Disorders Identification Test (AUDIT-10)(baseline, 6 months)
- CHESS Bonding Scale(baseline, 3 months, 6 months)