Mobile App for Alcoholic Liver Disease
(IMPACT-ALD Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen byAndrew Quanbeck, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Wisconsin, Madison
Disqualifiers: Liver transplant, Hospice, Cognitive impairment
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study staff or your doctor.
What data supports the effectiveness of the treatment Connections App, CHESS Health Connections, eRecovery Connections, Conexiones for Alcoholic Liver Disease?
Research shows that mobile health apps can help people with alcohol use disorder (AUD) engage in treatment, which is crucial for improving outcomes in alcohol-associated liver disease (ALD). Additionally, similar apps have been effective in supporting recovery from other substance use disorders, suggesting potential benefits for ALD patients.12345
Is the mobile app for Alcoholic Liver Disease safe for humans?
The mobile app, evaluated under different names like A-CHESS, has been tested for conditions related to alcohol use and substance use disorders. Studies have focused on its usability and satisfaction, but specific safety concerns have not been reported, suggesting it is generally safe for human use.12367
How is the Connections App treatment for alcoholic liver disease unique?
Eligibility Criteria
This trial is for individuals with alcohol-associated liver disease (ALD) who are being treated at two medical centers in Michigan and Wisconsin. It's open to patients from general hepatology clinics as well as those receiving integrated care for advanced ALD, mental health, and substance abuse.Inclusion Criteria
Alcohol use within the last 6 months
I have been diagnosed with alcoholic liver disease.
Receiving care at UW or UM in either the general hepatology clinic or the multidisciplinary ALD clinic
See 2 more
Exclusion Criteria
I am on the liver transplant list or have had a liver transplant.
I am currently receiving 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)
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants use the CHESS Health Connections app alongside usual care to support alcohol cessation
6 months
Monthly data collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Connections App (Behavioural Intervention)
Trial OverviewThe study is testing the CHESS Health Connections smartphone app's effectiveness in helping ALD patients quit drinking. Participants will be randomly assigned to use the app or not, and their progress will be tracked over a six-month period.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Connections AppExperimental Treatment1 Intervention
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.
Group II: Treatment as UsualActive Control1 Intervention
Connections App is already approved in United States for the following indications:
🇺🇸 Approved in United States as Connections App for:
- Alcohol-associated liver disease (ALD)
- Substance use disorder (SUD)
- Mental health support
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Henry Ford + Michigan State University Health CenterLansing, MI
UW Multidisciplinary ALD ClinicMadison, WI
UM Multidisciplinary ALD ClinicAnn Arbor, MI
UM General Hepatology ClinicAnn Arbor, MI
More Trial Locations
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Who Is Running the Clinical Trial?
University of Wisconsin, MadisonLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
National Institute on Drug Abuse (NIDA)Collaborator
References
Improving alcohol treatment engagement using integrated behavioral interventions in alcohol-associated liver disease: A randomized pilot trial. [2023]Alcohol cessation improves mortality in alcohol-associated liver disease (ALD), but few ALD patients will engage in treatment. We aimed to demonstrate the feasibility and acceptability of a mobile health intervention to increase alcohol use disorder (AUD) treatment among ALD patients.
Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. [2018]Mobile applications (apps) have created new opportunities in the field of alcohol dependence (AD) within new paradigms of shared decision-making and self-management. The aim of this study is to report the results of a pilot study testing the usability of and satisfaction with a mobile app (called SIDEAL) in AD patients.
A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. [2020]People who inject drugs are at a disproportionate risk for contracting hepatitis C virus (HCV). However, use of HCV prevention and treatment services remains suboptimal among people with substance use disorders due to various health system, societal, and individual barriers. Mobile health applications offer promising strategies to support people in recovery from substance use disorders. We sought to determine whether the Addiction-Comprehensive Health Enhancement Support System (A-CHESS), an existing mobile health application for opioid use disorder, could be adapted to improve HCV screening and treatment.
The patient buddy app can potentially prevent hepatic encephalopathy-related readmissions. [2018]Readmissions are a major burden in cirrhosis. A proportion of readmissions in cirrhosis, especially because of hepatic encephalopathy (HE) could be avoided through patient and caregiver engagement. We aimed to define the feasibility of using the Patient Buddy App and its impact on 30-day readmissions by engaging and educating cirrhotic inpatients and caregivers in a pilot study.
Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial. [2022]The extent of human interaction needed to achieve effective and cost-effective use of mobile health (mHealth) apps for individuals with mild to moderate alcohol use disorder (AUD) remains largely unexamined. This study seeks to understand how varying levels of human interaction affect the ways in which an mHealth intervention for the prevention and treatment of AUDs works or does not work, for whom, and under what circumstances.
Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. [2022]Hazardous drinking and alcohol use disorder (AUD) are substantial contributors to USA and global morbidity and mortality. Patient self-management and continuing care are needed to combat these public health threats. However, services are rarely provided to patients outside of clinic settings or following brief intervention. Smartphone applications ("apps") may help narrow the divide between traditional health care and patient needs. The purpose of this review is to identify and summarize smartphone apps to reduce alcohol consumption or treat AUD that have been evaluated for feasibility, acceptability, and/or efficacy. We searched two research databases for peer-reviewed journal articles published in English that evaluated smartphone apps to decrease alcohol consumption or treat AUD. We identified six apps. Two of these apps (A-CHESS and LBMI-A) promoted self-reported reductions in alcohol use, two (Promillekoll and PartyPlanner) failed to promote self-reported reductions in alcohol use, and two (HealthCall-S and Chimpshop) require further evaluation and testing before any conclusions regarding efficacy can be made. In summary, few evaluations of smartphone apps to reduce alcohol consumption or treat AUD have been reported in the scientific literature. Although advances in smartphone technology hold promise for disseminating interventions among hazardous drinkers and individuals with AUD, more systematic evaluations are necessary to ensure that smartphone apps are clinically useful.
Reducing Risky Alcohol Use via Smartphone App Skills Training Among Adult Internet Help-Seekers: A Randomized Pilot Trial. [2022]Alcohol is one of the leading risk factors for global disease burden and overconsumption leads to a wide variety of negative consequences in everyday life. Digital interventions have shown small positive effects in contributing to reductions in problematic use. Specific research on smartphone apps is sparse and the few studies published indicate effects ranging from negative or null to small or moderate. TeleCoach™, a web-based skills training smartphone app, has shown positive effects in non-treatment-seeking university students with excessive drinking. This pilot trial aimed to evaluate app effects in a sample of internet help-seekers from the general population in Sweden. A total of 89 participants were recruited via online advertisement. Following baseline assessment for hazardous use, they were randomized to TeleCoach or a web-based control app offering brief information and advice regarding problematic alcohol use. The primary outcome was number of standard drinks per week; secondary outcomes included drinking quantity and frequency, binge drinking and blood alcohol count measures as well as app user data and comorbidity related to depression, anxiety, and drug use. Analysis of baseline and 6-week follow-up outcomes showed significant within-group effects on alcohol consumption but no significant between-group differences. Effect sizes for the within-group changes in the primary outcome over time were significant [F(1, 55)=43.98; p < 0.001], with a Cohen's d of 1.37 for the intervention group and 0.92 for the control group. This difference in effect sizes indicated that continuation of the study as a large randomized, controlled trial with up to 1,000 participants could be worthwhile.
The Prescription of Mobile Apps by Primary Care Teams: A Pilot Project in Catalonia. [2019]In Catalonia, the Fundació TIC Salut Social's mHealth Office created the AppSalut Site to showcase to mobile apps in the field of health and social services. Its primary objective was to encourage the public to look after their health. The catalogue allows primary health care doctors to prescribe certified, connected apps, which guarantees a safe and reliable environment for their use. The generated data can be consulted by health care professionals and included in the patient's clinical history. This document presents the intervention and the major findings following a five-month pilot project conducted in the Barcelona area.
Implementation of a mobile application for outpatient care after liver transplantation. [2023]In the face of the Covid-19 pandemic and the need for social distancing new therapeutic tools like mobile health applications might gain in importance for outpatient care. Objective of the present study was to assess if and to what extent the implementation of a free available transplant application in a cohort of liver transplant recipients was possible.
Identification and Evaluation of Mobile Applications for Self-Management of Diet and Lifestyle for Patients with Inflammatory Bowel Disease. [2023]Mobile health applications (apps) providing diet and lifestyle self-management programs to patients with inflammatory bowel disease (IBD) are emerging. The objective of this study was to evaluate current apps available in the US and Canada based on app quality, perceived impact on diet and mental health and comprehensiveness to support self-management.
A better regulation is required in viral hepatitis smartphone applications. [2017]To describe the characteristics and content of the available viral hepatitis mobile applications, as well as assess the level of participation of medical professionals in their development.
Self-management in heart failure using mHealth: A content validation. [2023]To describe the development of a mobile health application -mICardiApp- designed by a multidisciplinary professional team and patients with heart failure and to evaluate its content validity.