Alcohol Treatment Engagement for Liver Disease

Overseen By Haila Asefa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cognitive impairment, Liver transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with alcohol-related liver disease engage more in treatment by offering tailored options to address their alcohol use and clear up any misunderstandings they might have. Participants will try different approaches, such as using the ENGAGE-ALD app (a digital application designed to support treatment engagement) or receiving enhanced usual care, to determine which method best promotes engagement. The trial suits those diagnosed with alcohol-related liver disease, who have used alcohol in the last six months, and who haven't received alcohol use treatment in the past month. Participants should also have access to a smartphone or computer to stay in touch with the study.

As an unphased trial, this study provides a unique opportunity to explore personalized treatment options that could enhance engagement and recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the ENGAGE-ALD app, a mobile health tool, helps people with alcohol-related liver disease manage their treatment more effectively. Studies have examined how patients perceive and use this app to quit drinking. So far, users have responded positively, and no major safety issues have emerged.

The Treatment Facilitation Bundle, another component of the study, follows current guidelines for treating alcohol-related liver disease. Although specific safety details for this bundle are not provided, it adheres to expert advice, suggesting it is likely safe.

Overall, both the app and the facilitation bundle appear safe based on current information. Participants should feel encouraged by these early findings, but discussing any concerns with healthcare providers remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENGAGE-ALD application because it offers a fresh approach to treating alcohol-related liver disease. Unlike traditional treatments that often focus on direct medical interventions, the ENGAGE-ALD app leverages technology to enhance patient engagement and adherence to alcohol treatment programs through personalized support and interactive features. This digital method aims to meet patients where they are, potentially increasing their motivation and success rates in reducing alcohol consumption. By incorporating a new delivery method—an app—it provides an accessible and potentially more effective way to support individuals in their recovery journey.

What evidence suggests that this trial's treatments could be effective for alcohol-related liver disease?

Research has shown that the ENGAGE-ALD app, a treatment in this trial, may increase patient involvement in managing alcohol-related liver disease. Earlier studies found the app easy to use and well-received, leading to early positive results in treatment engagement. Meanwhile, the Treatment Facilitation Bundle, another option in this trial that includes counseling, has improved outcomes for individuals with alcohol use disorder and liver disease. Even one session of behavioral therapy has been linked to better liver function and fewer complications. Both treatments aim to help patients reduce alcohol use, which is expected to improve liver health. ^{1 2 5 6 7}

Who Is on the Research Team?

Jessica Mellinger, MD, MSc

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with alcohol-related liver disease. It's aimed at those who may benefit from tailored treatment options to help them engage more effectively with their treatment and address any misunderstandings about their condition.

Inclusion Criteria

I haven't received any alcohol use treatment in the last month.

I am willing and able to follow all study rules and attend all appointments.

Willing and able to provide informed consent

Exclusion Criteria

Substantially cognitively impaired as evidenced by Westhaven grade 2 or higher hepatic encephalopathy or a score >=10 on the Short Blessed Test for cognitive impairment

Any other medical condition or circumstance that precludes safe and meaningful participation in the study

Unable to provide voluntary informed consent for any reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Participants receive either the ENGAGE-ALD app or Enhanced Usual Care for three months

12 weeks

Varies based on treatment engagement

Stage 2 Treatment

Non-responders are re-randomized to either continue with the initial treatment or switch to the Treatment Facilitation Bundle for another three months

12 weeks

Varies based on treatment engagement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ENGAGE-ALD Application (APP)
• Enhanced Usual Care
• Treatment Facilitation bundle

Trial Overview The study is testing three approaches: an ENGAGE-ALD Application (APP) designed to support patients, a Treatment Facilitation bundle that provides additional resources, and Enhanced Usual Care which represents the standard approach to care.

How Is the Trial Designed?

Group I: Enhanced usual care then Treatment Facilitation Bundle Experimental Treatment 2 Interventions

Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).

Group II: Enhanced usual care then Enhanced usual care Experimental Treatment 1 Intervention

Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be rerandomized to the Enhanced usual care arm stage 2 (three months).

Group III: Enhanced usual care (EUC) Experimental Treatment 1 Intervention

Eligible participants randomized will be given this for stage 1 of treatment (three months) and stage 2 (three months) if participants engaged in alcohol treatment during the first stage of treatment.

Group IV: ENGAGE-ALD application (app) Experimental Treatment 1 Intervention

Eligible participants randomized to this arm will be given this for stage 1 (three months) of treatment and stage 2 (three months) if participants engaged in alcohol treatment during the first stage of treatment.

Group V: ENGAGE-ALD app then Treatment Facilitation Bundle Experimental Treatment 2 Interventions

Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).

Group VI: ENGAGE-ALD app then Enhanced usual care Experimental Treatment 1 Intervention

Eligible participants randomized to this arm will be given this for stage 1 (three months) of treatment. Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized to the EUC arm stage 2 (three months).

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

Smartphone health apps show consistent clinical benefits primarily for diabetes management, evidenced by reduced HbA1c levels, while benefits for other chronic diseases are either absent or marginal.

A proposed evaluation framework identifies 12 design features that enhance usability and efficacy, highlighting the need for standardized assessments to ensure the quality and effectiveness of health apps before endorsement by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Going digital: a narrative overview of the effects, quality and utility of mobile apps in chronic disease self-management. Scott, IA., Scuffham, P., Gupta, D., et al.[2020]

A pilot study involving 60 adults with alcohol-associated liver disease (ALD) showed that a mobile health intervention significantly increased engagement in alcohol use disorder (AUD) treatment, with 27.3% of participants in the intervention group seeking treatment compared to 13.3% in the control group after 6 months.

The intervention was highly acceptable to participants, with 91% expressing satisfaction, and it also suggested a trend towards reduced alcohol consumption, indicating that mobile health tools can be effective in supporting treatment engagement among ALD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving alcohol treatment engagement using integrated behavioral interventions in alcohol-associated liver disease: A randomized pilot trial. Mellinger, JL., Medley, S., Kidwell, KM., et al.[2023]

Individuals diagnosed with alcohol-associated liver disease (ALD) see their diagnosis as a strong motivator to quit drinking, but they often struggle to find effective resources for alcohol cessation due to overwhelming information about their condition.

An mHealth app designed for alcohol cessation was well-received by patients with ALD, showing high usage rates and positive feedback on its self-tracking and motivational features, indicating its potential as a supportive tool for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing a Digital Health App for Patients With Alcohol-Associated Liver Disease: Mixed Methods Usability Study. Park, LS., Kornfield, R., Yezihalem, M., et al.[2023]

A systematic review of diabetes mobile applications found that while usability ratings from users and experts ranged from 38% to 80%, significant usability issues such as complex navigation and limited functionality were common.

Despite these usability challenges, diabetes apps showed some clinical effectiveness, with reductions in HbA1c levels between 0.15% and 1.9%, indicating potential for improving glycemic control in adults with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. Fu, H., McMahon, SK., Gross, CR., et al.[2022]

In a study of 136 patients with alcohol-associated liver disease (ALD) followed for a median of 1 year, 17% relapsed, with those who relapsed more likely to continue drinking despite liver disease and less likely to have received a transplant.

The study identified that insight into alcohol-use disorder (measured by the Hanil Alcohol Insight Scale) and social support at home (measured by the Community Assessment Inventory Scale) were predictive of relapse, highlighting the potential for targeted interventions to reduce relapse risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Quantifiable Predictors of Relapse in Patients with Alcohol-Associated Liver Disease. Shen, NT., Kaplan, A., Fahoum, K., et al.[2023]

Diabetes-related apps combined with virtual coaching can significantly improve glycemic control and promote meaningful behavior changes compared to using apps alone, addressing common treatment barriers effectively.

Users of these enhanced apps report high satisfaction and prolonged engagement, suggesting that virtual coaching may be a valuable tool in diabetes education, although further research is needed to explore its long-term effects across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Coaching to Enhance Diabetes Care. Ramchandani, N.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10503679/

Improving alcohol treatment engagement using integrated ... A mobile health intervention for AUD treatment engagement was highly feasible, acceptable, and produced promising early outcomes.

2. withpower.com withpower.com/trial/phase-alcohol-related-liver-disease-1-2024-1b628

Alcohol Treatment Engagement for Liver Disease The ENGAGE-ALD App is unique because it uses a mobile health platform to increase engagement in alcohol use disorder treatment specifically for patients ...

3. trialx.com trialx.com/clinical-trials/listings/296742/implementation-of-mobile-based-programs-for-alcohol-cessation-in-treatment-of-alcohol-associated-liver-disease/

Alcohol-related Liver Disease ) ( NCT06305624 ) This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone ...

4. formative.jmir.org formative.jmir.org/2023/1/e47404/

Testing a Digital Health App for Patients With Alcohol ... This study aims to understand how individuals with ALD would perceive and use an mHealth tool for alcohol cessation and to gather their perspectives on ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687677/

Testing a Digital Health App for Patients With Alcohol ... This study aims to understand how individuals with ALD would perceive and use an mHealth tool for alcohol cessation and to gather their perspectives on ...

6. journals.lww.com journals.lww.com/hepcomm/fulltext/2023/10010/improving_alcohol_treatment_engagement_using.12.aspx

Improving alcohol treatment engagement using integrated... Many patients with ALD have misconceptions about alcohol use, AUD treatment, and liver disease that may represent targets for interventions to overcome barriers ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291823003818

Multidisciplinary Care of Alcohol-related Liver Disease and ... We performed a narrative review of epidemiology, clinical manifestations, and management strategies in AUD and ALD, with a particular focus on areas of overlap.