RECRUITING

Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity (DRINK-LESS)

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

Per the 2021 National Survey on Drug Use and Health administered by the U.S. Department of Health and Human Services, 85% of all American adults consume alcohol. Atrial fibrillation (AF) is the most common arrhythmia, affecting more than 10 million individuals in U.S., comprising 4.5% of the adult population. Although alcohol abstinence clearly reduces AF in heavy drinkers, observational data comparing the health effects of limited consumption versus abstention are conflicting. The Mediterranean diet is one of the few that has demonstrated clear cardiovascular benefits in a randomized study-this diet allows for the consumption of red wine (or high polyphenol/ low alcohol alcohol), generally not more than one drink in 24 hours, with meals, avoiding spirits and binge drinking. The effect of the "Mediterranean drinking pattern" on AF risk compared to alcohol abstinence remains unknown. This single center, randomized, controlled trial aims to compare the effects of a digital health intervention to encourage durable alcohol abstinence versus allowing guideline-adherent moderate alcohol consumption on AF severity. The knowledge gained from this study may be used to determine optimal thresholds for alcohol use among AF patients.

Official Title

Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity

Quick Facts

Study Start:2025-04-20
Study Completion:2030-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06995391

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:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are age 21 years or older
  2. * Have a smartphone
  3. * Are able to use the Eureka mobile application
  4. * Have a history of paroxysmal or persistent atrial fibrillation (AF)
  5. * Have consumed alcohol at least once per month on average in the past year
  6. * Willing to receive messaging encouraging alcohol abstinence
  1. * Non-english speaker
  2. * Currently pregnant or trying to get pregnant
  3. * A healthcare professional's instruction to avoid alcohol (for any reason)
  4. * Currently incarcerated
  5. * Permanent AF (meaning a medical determination has been made that sinus rhythm would definitely never be pursued in this patient)
  6. * Are unable to read or sign to provide informed consent

Contacts and Locations

Study Contact

Gregory M Marcus, MD, MAS
CONTACT
415-476-5706
greg.marcus@ucsf.edu
Gabrielle C Montenegro, BA
CONTACT
415-502-3053
gabby.montenegro2@ucsf.edu

Principal Investigator

Gregory M Marcus, MD, MAS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

UCSF Medical Center at Parnassus
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Gregory M Marcus, MD, MAS, 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 Date2025-04-20
Study Completion Date2030-03-01

Study Record Updates

Study Start Date2025-04-20
Study Completion Date2030-03-01

Terms related to this study

Keywords Provided by Researchers

  • Atrial Fibrillation
  • AFib
  • Alcohol
  • Mediterranean Drinking Pattern
  • Red wine

Additional Relevant MeSH Terms

  • Atrial Fibrillation (AF)