ACTIVE_NOT_RECRUITING

Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study consists of a randomized controlled trial evaluating the efficacy and feasibility of a stepped alcohol treatment using telemedicine on unhealthy alcohol use in patients with chronic liver disease receiving care in hepatology practices at three sites. Patients who meet eligibility criteria will be randomized to one of two study arms: 1) Stepped Alcohol Treatment (SAT) or, 2) Usual Care (UC). Participants will be randomized separately by site. SAT includes 3 sessions of motivational interviewing followed by referral to addiction medicine for patients who do not reduce unhealthy drinking. Trial outcome measures will be complete at 6 and 12 months following baseline enrollment.

Official Title

Impact of the Coronavirus 2019 (COVID-19) Pandemic on Patient Outcomes, Telehealth Care Delivery, and Treatment for Unhealthy Alcohol Use in Vulnerable Patients With Advanced Liver Disease Across Two Healthcare Systems

Quick Facts

Study Start:2022-02-01

Study Completion:2026-02-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05191446

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Men and women age ≥ 18 years. 2. Diagnosis of chronic liver disease (CLD). 3. Unhealthy alcohol use, defined as more than moderate amount of alcohol use within the prior 30 days by National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria defined as on average more than 1 drink/day (7 drinks per week) for women and more than 2 drinks per day (14 drinks per week) for men, or on average at least one heavy drinking day (4+ drinks in a day for women and 5+ for men) per week in the prior 30 days. A standard drink is \~14 g of alcohol. 4. Ability to access a telephone or a digital device (i.e., computer, tablet or smart phone).	1. Severe medical or psychiatric conditions or evidence of acute alcohol intoxication preventing participation in the study 2. Are currently enrolled in formal treatment for unhealthy alcohol use, excluding self or mutual-help groups (e.g., Alcoholics Anonymous). 3. Women who are pregnant or breastfeeding or unwilling to use birth control. 4. Language preference other than English, Spanish or Chinese. 5. Unwilling or unable to provide informed consent.

Inclusion Criteria

Exclusion Criteria

1. Men and women age ≥ 18 years.
2. Diagnosis of chronic liver disease (CLD).
3. Unhealthy alcohol use, defined as more than moderate amount of alcohol use within the prior 30 days by National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria defined as on average more than 1 drink/day (7 drinks per week) for women and more than 2 drinks per day (14 drinks per week) for men, or on average at least one heavy drinking day (4+ drinks in a day for women and 5+ for men) per week in the prior 30 days. A standard drink is \~14 g of alcohol.
4. Ability to access a telephone or a digital device (i.e., computer, tablet or smart phone).

1. Severe medical or psychiatric conditions or evidence of acute alcohol intoxication preventing participation in the study
2. Are currently enrolled in formal treatment for unhealthy alcohol use, excluding self or mutual-help groups (e.g., Alcoholics Anonymous).
3. Women who are pregnant or breastfeeding or unwilling to use birth control.
4. Language preference other than English, Spanish or Chinese.
5. Unwilling or unable to provide informed consent.

Contacts and Locations

Principal Investigator

Mandana Khalili, M.D.

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of california San Francisco

San Francisco, California, 94110

United States

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Mandana Khalili, M.D., PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01

Study Completion Date2026-02-27

Study Record Updates

Study Start Date2022-02-01

Study Completion Date2026-02-27

Terms related to this study

Additional Relevant MeSH Terms

Liver Diseases
Alcohol Use Disorder