Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Connections App.
- Кому может быть актуально
- Состояния в реестре: Alcohol Use Disorder, Alcohol-related Liver Disease. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease (IMPACT-ALD): Aim 1
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство Connections App
mobile application, a place where participants can find community and support to help them manage their ALD, learn liver health self-care, coping skills, and alcohol abstinence strategies.
Первичные конечные точки
- Days of Alcohol Abstinence in ALD Participants [Срок оценки: data collected monthly, up to 6 months]
- Number of Standard Drinks Consumed in ALD Participants [Срок оценки: data collected monthly, up to 6 months]
Вторичные конечные точки (11)
- Change in Patient Health Questionnaire (PHQ-8) Score [Срок оценки: baseline, 3 months, 6 months]
- Change in PROMIS Global Health Score [Срок оценки: baseline, 3 months, 6 months]
- Change in Generalized Anxiety Disorder (GAD-7) Score [Срок оценки: baseline, 3 months, 6 months]
- Change in Insomnia Severity Index (ISI) Score [Срок оценки: baseline, 3 months, 6 months]
- Change in Pain Interference (PEG) Score [Срок оценки: baseline, 3 months, 6 months]
- Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score [Срок оценки: baseline, 3 months, 6 months]
- Change in CHESS Bonding Scale Score [Срок оценки: baseline, 3 months, 6 months]
- Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score [Срок оценки: baseline, 3 months, 6 months]
- Change in Treatment Self-Regulation Questionnaire (TSRQ) Score [Срок оценки: baseline, 3 months, 6 months]
- Alcohol Use Disorders Identification Test (AUDIT-10) [Срок оценки: baseline, 6 months]
- CHESS Bonding Scale [Срок оценки: baseline, 3 months, 6 months]
Критерии участия
Inclusion Criteria (Aim 1):
- 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
Критерии исключения
- 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.)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 3 центра
- Henry Ford + Michigan State University Health Center — Lansing
- UW General Hepatology Clinic — Madison
- UW Multidisciplinary ALD Clinic — Madison
Идентификаторы
NCT: NCT06305624 · 2024-0130 · 1R01AA030470-01A1 · A532000 · Protocol Version 4/23/26