Mobile App for Alcoholic Liver Disease

(IMPACT-ALD Trial)

Recruiting at 4 trial locations

Overseen By Jared P McDonald, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Liver transplant, Hospice, Cognitive impairment

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

298 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

How is the Connections App treatment for alcoholic liver disease unique?

The Connections App is unique because it uses a mobile app to support self-management and connect patients with healthcare professionals, which is different from traditional treatments that may not offer this level of digital engagement and real-time data sharing. ^{8 9 10 11 12}

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.

Research Team

Andrew Quanbeck, PhD

Principal Investigator

University of Wisconsin, Madison

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

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)

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

Trial Overview The 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

Group I: Connections App Experimental Treatment 1 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 Usual Active Control 1 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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

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]

The SIDEAL mobile app was well-accepted by 24 adult patients with alcohol dependence, showing high usage rates (80% of study days) and high satisfaction levels, particularly with its self-register and feedback features.

Participants experienced significant reductions in alcohol consumption over 6 weeks, with binge drinking days decreasing from an average of 25 to 5.8 and mean daily consumption dropping from 6.5 to 1.9 standard units, indicating the app's potential efficacy in managing alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. Barrio, P., Ortega, L., López, H., et al.[2018]

The A-CHESS mobile health application was adapted to include an HCV intervention, providing educational resources and tailored support to improve HCV screening and treatment among individuals with opioid use disorder, with 416 participants enrolled in the study.

Preliminary data showed that among those who had ever tested HCV antibody-positive, a significant proportion were linked to medical care and treated, indicating that integrating HCV services into addiction treatment programs may enhance health outcomes for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. Hochstatter, KR., Gustafson, DH., Landucci, G., et al.[2020]

The Patient Buddy App was successfully used in a pilot study with 40 cirrhotic inpatients and their caregivers, showing feasibility in tracking medication adherence and health metrics post-discharge.

The App potentially prevented eight readmissions related to hepatic encephalopathy (HE) by facilitating early outpatient interventions, highlighting its effectiveness in reducing hospital readmissions in cirrhosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient buddy app can potentially prevent hepatic encephalopathy-related readmissions. Ganapathy, D., Acharya, C., Lachar, J., et al.[2018]

This study aims to evaluate the effectiveness of a mobile health (mHealth) app for individuals with mild to moderate alcohol use disorder (AUD) by comparing three levels of human interaction: self-monitored, peer-supported, and clinically integrated, with 357 participants enrolled out of a planned 546.

The research will assess changes in risky drinking patterns and quality of life, as well as the cost-effectiveness of each approach, providing valuable insights for integrating technology into healthcare for AUD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial. Park, LS., Chih, MY., Stephenson, C., et al.[2022]

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]

The pilot trial involving 89 participants showed that the TeleCoach app led to significant reductions in alcohol consumption over 6 weeks, with a large effect size (Cohen's d of 1.37) for the intervention group.

While the TeleCoach app demonstrated positive within-group effects, there were no significant differences between the app and the control group, suggesting further research with a larger sample size (up to 1,000 participants) is needed to fully evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Risky Alcohol Use via Smartphone App Skills Training Among Adult Internet Help-Seekers: A Randomized Pilot Trial. Berman, AH., Molander, O., Tahir, M., et al.[2022]

The AppSalut pilot project successfully demonstrated that mobile health apps can be prescribed by doctors and that patient data can be reliably transmitted and integrated into clinical records, with 32 doctors recommending apps to patients who uploaded data an average of 13 times each.

User perception of the app's utility and face-to-face support from healthcare providers were identified as crucial for successful implementation, highlighting the importance of user engagement and training in telemedicine transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Prescription of Mobile Apps by Primary Care Teams: A Pilot Project in Catalonia. Lopez Segui, F., Pratdepadua Bufill, C., Abdon Gimenez, N., et al.[2019]

In a study involving 135 liver transplant recipients, 91.9% participated, and 57.3% owned a mobile device capable of using a transplant application, with 33.8% trying it out for 2 months.

After 2 months, 57.1% of those who tested the application successfully integrated it into their daily routine, indicating that while the app was helpful for therapy management, improvements are needed for older patients who require more support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a mobile application for outpatient care after liver transplantation. Andrä, M., Sibinovic, M., Pfeiffer, K., et al.[2023]

Out of 1,512 mobile health apps identified for inflammatory bowel disease (IBD), only six met the criteria for quality and relevance, highlighting a gap in effective self-management tools for diet and lifestyle.

The apps 'My IBD Care: Crohn's and Colitis' and 'LyfeMD' received the highest ratings for quality and functionality, including behavior tracking, suggesting they may be beneficial for patients managing IBD, but their actual impact on health outcomes needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and Evaluation of Mobile Applications for Self-Management of Diet and Lifestyle for Patients with Inflammatory Bowel Disease. Gold, SL., Chiew, BA., Rajagopalan, V., et al.[2023]

A total of 33 viral hepatitis mobile applications were identified, with most categorized under medical, but many contained unvalidated information, highlighting the need for certification of these apps.

Health professionals participated in the development of 56.6% of the apps, indicating a significant involvement of medical expertise, yet only a few apps had high user ratings or substantial downloads, suggesting room for improvement in quality and user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A better regulation is required in viral hepatitis smartphone applications. Cantudo-Cuenca, MR., Robustillo-Cortés, MA., Cantudo-Cuenca, MD., et al.[2017]

The mICardiApp, developed with input from both healthcare professionals and patients with heart failure, aims to enhance health literacy and self-management for individuals with heart failure and multimorbidity.

The app's content was rigorously validated, achieving a high Content Validity Index (CVI) of 0.851, indicating that most of its screens (57 out of 59) were deemed relevant and adequate by experts, ensuring its effectiveness as a health management tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management in heart failure using mHealth: A content validation. Fernández-Gutiérrez, M., Bas-Sarmiento, P., Jesús Marín-Paz, A., et al.[2023]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. [2020]

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

The patient buddy app can potentially prevent hepatic encephalopathy-related readmissions. [2018]

5. Canada pubmed.ncbi.nlm.nih.gov

Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial. [2022]

6. 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]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Reducing Risky Alcohol Use via Smartphone App Skills Training Among Adult Internet Help-Seekers: A Randomized Pilot Trial. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

The Prescription of Mobile Apps by Primary Care Teams: A Pilot Project in Catalonia. [2019]

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

Implementation of a mobile application for outpatient care after liver transplantation. [2023]

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

Identification and Evaluation of Mobile Applications for Self-Management of Diet and Lifestyle for Patients with Inflammatory Bowel Disease. [2023]

11. Spain pubmed.ncbi.nlm.nih.gov

A better regulation is required in viral hepatitis smartphone applications. [2017]

12. Ireland pubmed.ncbi.nlm.nih.gov

Self-management in heart failure using mHealth: A content validation. [2023]