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

268 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the ENGAGE-ALD Application (APP) treatment for liver disease?

Research shows that smartphone apps can help with self-care in chronic diseases like diabetes, but evidence of their benefit for other conditions, including liver disease, is limited. However, apps with features that enhance usability and engagement may offer some support in managing health behaviors. ^{1 2 3 4 5}

Is the Alcohol Treatment Engagement for Liver Disease generally safe for humans?

The research articles do not provide specific safety data for the Alcohol Treatment Engagement for Liver Disease or its related interventions. They focus on feasibility, acceptability, and effectiveness in reducing alcohol use, but do not mention any safety concerns. ^{6 7 8 9 10}

How is the ENGAGE-ALD App treatment different from other treatments for alcohol-associated 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 with alcohol-associated liver disease, offering a convenient and scalable support option that is not typically available in standard care. ^{6 7 10 11 12}

What is the purpose of this trial?

The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions.

Research Team

Jessica Mellinger, MD, MSc

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Going digital: a narrative overview of the effects, quality and utility of mobile apps in chronic disease self-management. [2020]

2. Ireland pubmed.ncbi.nlm.nih.gov

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Patterns of User Engagement with Mobile- and Web-Delivered Self-Care Interventions for Adults with T2DM: A Review of the Literature. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a smartphone application for self-care performance of patients with chronic hepatitis B: A randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Virtual Coaching to Enhance Diabetes Care. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Improving alcohol treatment engagement using integrated behavioral interventions in alcohol-associated liver disease: A randomized pilot trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Reducing the Global Burden of Alcohol-Associated Liver Disease: A Blueprint for Action. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Challenges and Solutions for Monitoring Alcohol Use in Patients With Alcohol-Related Liver Disease: Pilot Study of a Wearable Alcohol Biosensor. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Identification of Quantifiable Predictors of Relapse in Patients with Alcohol-Associated Liver Disease. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Computer-delivered brief alcohol intervention for patients with liver disease: a randomized controlled trial. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Testing a Digital Health App for Patients With Alcohol-Associated Liver Disease: Mixed Methods Usability Study. [2023]