Digital Clinic for Alcoholism and Liver Disease

(DALC Trial)

Not currently recruiting at 1 trial location

Overseen By Camille Kezer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Inability to provide consent

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the DALC Digital Clinic, a digital health platform, can improve care for individuals with alcohol-associated liver disease (ALD) and alcohol use disorder (AUD). Participants will either use a smartphone app for personalized care or receive standard treatment from their usual doctors. The researchers aim to demonstrate that the digital clinic can improve health outcomes, reduce costs, and increase satisfaction for both patients and doctors. Individuals with ALD who consult a hepatologist at Mayo Clinic and can use a smartphone might be suitable candidates. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance future care for ALD and AUD.

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 trial coordinators or your healthcare provider.

What prior data suggests that the DALC Digital Clinic is safe for patients with ALD and AUD?

Research has shown that digital clinics, such as the DALC Digital Clinic, are generally safe for patients. Studies on clinics for alcohol-related liver disease (ALD) have not identified major safety issues. These clinics aim to combine various types of care to manage liver disease effectively without adding extra risks.

The digital clinic's main goal is to improve patient health by offering personalized treatment through a smartphone or tablet app. This method has been used in other areas and is typically well-received by patients. The DALC Digital Clinic employs a team-based approach, which may provide additional benefits without compromising safety.

While specific safety data may not be available, digital health platforms are often considered low-risk. They aim to improve communication and help patients adhere to their treatment plans, potentially leading to better health outcomes. For those considering joining the trial, this digital clinic is designed to support, not replace, regular medical care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Clinic for Alcoholism and Liver Disease because it leverages the Ria Treatment Platform (RTP), a digital application that patients can easily download onto their smartphones or tablets. Unlike traditional treatments that typically involve in-person therapy sessions or medication, this digital approach provides a more accessible and convenient way for patients to receive support and track their progress. This method is particularly appealing as it can be personalized to the individual's needs and integrated into their daily life seamlessly. The innovation lies in its potential to enhance patient engagement and adherence, which are crucial for successful treatment outcomes in alcoholism and liver disease.

What evidence suggests that the DALC Digital Clinic is effective for improving outcomes in patients with ALD and AUD?

Research has shown that using a digital clinic to manage alcohol-related liver disease (ALD) and alcohol use disorder (AUD) can be effective. In this trial, participants in the Digital Clinic Arm will use the Ria Treatment Platform (RTP) application, which connects liver doctors, mental health experts, and addiction counselors to provide care. Studies have found that this method can reduce liver damage, decrease alcohol use, and lead to fewer emergency room visits. Patients often experience significant improvement in their symptoms, known as remission. Completely stopping alcohol use is linked to better health for those with liver problems. ^{1 3 4 5 6}

Who Is on the Research Team?

Douglas Simonetto, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with alcohol-associated liver disease (ALD) and alcohol use disorder (AUD). It's designed to see if a digital clinic can help improve their health outcomes. Participants should be comfortable using digital tools for treatment.

Inclusion Criteria

Provider: Hepatology Providers at Mayo Clinic Rochester and Scottsdale

I have liver disease related to alcohol use.

Exclusion Criteria

Provider: Providers in other divisions

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized multi-disciplinary treatment through a digital health platform or standard care

6 months

Ongoing digital and in-person interactions

Follow-up

Participants are monitored for clinical outcomes such as hepatic decompensation, MELD 3.0 score, and alcohol use

6 months

What Are the Treatments Tested in This Trial?

Interventions

• DALC Digital Clinic

Trial Overview The DALC Digital Clinic, a multidisciplinary online platform, is being tested to see if it can enhance the care of patients with ALD and AUD by improving health results, reducing costs, increasing access to care, and boosting satisfaction for both providers and patients.

How Is the Trial Designed?

Group I: Digital Clinic Arm Experimental Treatment 1 Intervention

The Ria Treatment Platform (RTP) application will be downloaded onto the patient's smart phone or tablet.

Group II: Standard of Care Arm Active Control 1 Intervention

Primary care providers will treat subject per standard of care utilizing the Interactive Care Plan program.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Ria Health

Industry Sponsor

Trials

2

Recruited

160+

Published Research Related to This Trial

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 multidisciplinary clinic for alcohol-associated liver disease (ALD) showed promising early outcomes, with 51 patients seen in the first year and significant improvements in liver function, as indicated by a decrease in the mean MELD-Na score from 14 to 11.3 over 6 months.

Patients in the clinic experienced a notable reduction in hospital utilization, with emergency department visits dropping from 0.51 to 0.20 per person-month and inpatient admissions decreasing from 0.34 to 0.14 per person-month, suggesting effective management of their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and early experience of a novel multidisciplinary alcohol-associated liver disease clinic. Mellinger, JL., Winder, GS., Fernandez, AC., et al.[2022]

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]

Alcohol-associated liver disease is the leading cause of hospitalization for chronic liver disease, with rising rates of alcohol-associated hepatitis over the past 20 years, highlighting the need for effective postdischarge management.

There is currently no standardized approach for managing patients after hospitalization for alcohol-associated hepatitis, necessitating strategies that address both liver disease and alcohol use disorder to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Patients After Treatment of Severe Alcohol-associated Hepatitis. Shetty, A., Ibrahim, B., Eskander, B., et al.[2023]

Individuals with co-occurring alcohol use disorders (AUD) and alcohol-associated liver disease (ALD) often lack access to effective treatment, particularly in rural areas where specialty care is limited.

Implementing telehealth within an integrated care model could enhance access to treatment for AUD and ALD, potentially improving recovery outcomes by addressing both conditions simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated care models for co-occurring alcohol use disorders and alcohol-associated liver disease in rural communities: Telehealth considerations and opportunities. Osman, M., Koneru, G., Weber, A.[2023]

An integrated approach combining hepatology and addiction medicine significantly improved the uptake of medical alcohol therapy, screening for hepatic fibrosis, and vaccination for viral hepatitis in inpatients with alcohol use disorder.

While this integrated care model enhanced certain medical outcomes, it did not show a difference in early alcohol remission rates compared to patients receiving only addiction medicine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated hepatology and addiction care for inpatients with alcohol use disorder improves outcomes: a prospective study. Mahle, R., McLean Diaz, P., Marshall, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06319222

Implementation of a Digital Clinic for Alcohol-associated ... All patients will receive nursing education on alcohol abstinence at ICP enrollment and longitudinal management of their liver disease (current state).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10500286/

Integrated Multidisciplinary Management of Alcohol ... This review details the integrated multidisciplinary care model especially on the specific role of the hepatologist, psychiatrist, addiction counselor, and ...

3. journals.lww.com journals.lww.com/hepcomm/fulltext/2025/02010/the_impact_of_integrated_care_on_clinical_outcomes.18.aspx

The impact of integrated care on clinical outcomes in... Our integrated approach led to reductions in liver injury, degree of liver decompensation, alcohol use, and ED utilization, and remission in AUD.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34118717/

Feasibility and early experience of a novel ... - PubMed Conclusions: A multidisciplinary ALD clinic was feasible with encouraging early outcomes. Further research should explore ways to expand this model and increase ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1542356523001593

Alcohol-Associated Liver Disease: Integrated Management ... At all stages of liver disease, including decompensated cirrhosis, achieving and maintaining alcohol abstinence substantially improve the patient's prognosis.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06319222/implementation-of-a-digital-clinic-for-alcohol-associated-liver-disease-and-alcohol-use-disorder-dalc

Implementation of a Digital Clinic for Alcohol-associated ... The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, ...