Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity
a study on Atrial Fibrillation Heart Conditions
Summary
- Eligibility
- for people ages 21 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedstudy ends around
- Principal Investigator
- by Gregory M Marcus, MD, MAS (ucsf)
Description
Summary
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.
Details
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. Any English-speaking individual over the age of 21, with a diagnosis of paroxysmal or persistent AF, who consumes alcohol at least once per month and is willing to receive messaging encouraging alcohol abstinence, will be eligible to participate in this study.
Participants will be randomly assigned to one of two digital health interventions for one year. Those randomly assigned to the Contemporary Guideline-Adherence Arm will receive weekly app and text-based messaging encouraging them not to exceed guideline-directed amounts of alcohol, as well as messaging explaining that abstinence is acceptable and may be the best way to avoid AF and that, if a participant decides to consume alcohol, a Mediterranean drinking pattern may be the most healthy. Those randomly assigned to the Alcohol Abstinence Arm will receive weekly app- and text-based messaging encouraging avoidance of all alcohol consumption. Throughout the study, alcohol consumption (or abstinence) and atrial fibrillation episodes and severity will be assessed by serial surveys. Abstinence will also be objectively assessed via urine ethyl glucuronide (EtG) tests and a blood test for phosphatidylethanol (PEth) in randomly selected participants in each Arm. A minimum of 1,000 participants and up to 10,000 participants will be enrolled in the study.
Keywords
Atrial Fibrillation (AF), Atrial Fibrillation, AFib, Alcohol, Mediterranean Drinking Pattern, Red wine, Ethanol, Contemporary Guideline-Adherence, Alcohol Abstinence
Eligibility
You can join if…
Open to people ages 21 years and up
- Are age 21 years or older
- Have a smartphone
- Are able to use the Eureka mobile application
- Have a history of paroxysmal or persistent atrial fibrillation (AF)
- Have consumed alcohol at least once per month on average in the past year
- Willing to receive messaging encouraging alcohol abstinence
You CAN'T join if...
- Non-english speaker
- Currently pregnant or trying to get pregnant
- A healthcare professional's instruction to avoid alcohol (for any reason)
- Currently incarcerated
- Permanent AF (meaning a medical determination has been made that sinus rhythm would definitely never be pursued in this patient)
- Are unable to read or sign to provide informed consent
Location
- UCSF Medical Center at Parnassus
accepting new patients
San Francisco California 94143 United States
Lead Scientist at University of California Health
- Gregory M Marcus, MD, MAS (ucsf)
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- University of California, San Francisco
- ID
- NCT06995391
- Study Type
- Interventional
- Participants
- Expecting 1000 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Providing your contact details does not obligate you to participate in the research.
Thank you!
The study team should get back to you in a few business days.