Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC)

NCT06319222 | Active Not Recruiting

• 1 other identifier: 23-007870
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction. The primary aim of this study is to improve clinical outcomes in patients with ALD through the implementation of a novel digital health platform for personalized multi-disciplinary treatment of patients with ALD and AUD. Secondary aims include improvement in provider and patient-reported outcomes including satisfaction with AUD treatment.

Conditions

Alcohol Use Disorder; Liver Diseases

Keywords

Alcohol; Liver; Disorder

Outcome Measures

Primary Outcomes (1)

• Median delta MELD-3.0 from baseline to end of study.

  The primary aim of this study is to improve clinical outcomes in patients with ALD as defined as median delta MELD-3.0 from baseline to the end of the study.

  6 months

Secondary Outcomes (3)

• Sustained alcohol abstinence

  6 months

• Reduction of Number of hospitalizations

  6 months

• Greater provider satisfaction in DALC arm

  6 months

Study Arms (2)

Standard of Care Arm

NO INTERVENTION

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

Digital Clinic Arm

OTHER

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

Other: DALC Digital Clinic

Interventions

DALC Digital Clinic OTHER

Providers randomized to the intervention arm will be able to refer their patients with ALD, to the DALC in addition to standard of care. Patients with providers randomized to the intervention arm will be consented by the study team. After appropriate consent, the referred patients will be instructed by our study team to download the RTP application in their smart devices (smartphones or tablets).

Digital Clinic Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provider-Hepatology Providers at Mayo Clinic Rochester and Scottsdale
• Patient-Age ≥ 18 y.o.
• Patient-Alcohol-associated liver disease

You may not qualify if:

• Provider-Providers in other divisions
• Patient-Inability to provide consent

Sponsors & Collaborators

• Mayo Clinic: lead
• Ria Health: collaborator

Study Sites (2)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Alcoholism; Liver Diseases; Disease

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas Simonetto, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)