Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity
- Conditions
- Atrial Fibrillation (AF)
- Registration Number
- NCT06995391
- Lead Sponsor
- University of California, San Francisco
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in atrial fibrillation severity at one year From baseline to one year of study participation. The primary outcome will be change in atrial fibrillation severity at one year, defined by a change in the Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) score from baseline to one year associated with alcohol abstinence.
Based on previously reported values of clinically relevant change in AFEQT score (PMID 31092022), the investigators estimate the change in mean AFEQT score from baseline to 1 year to be 5.4±17.03 in the Alcohol Abstinence group and 0.2±15.17 in the Contemporary Guideline-Adherence group, giving a 5.2 difference between the two groups. The investigators estimate that 1,000 patients would provide \~99% power to detect this difference with as much as 30% overall attrition, and 30% crossover from abstinence to drinking regularly and 20% crossover from drinking regularly to abstinence.
- Secondary Outcome Measures
Name Time Method Total number of negative urine ethyl glucuronide tests at one year From baseline to one year of study participation. Abstinence will be objectively assessed via urine ethyl glucuronide (EtG) tests in a random sample of 100 participants in each group. A secondary outcome will be the total number of negative EtG tests at approximately one year.
Results of the phosphatidylethanol test at one year At one year of study participation. At approximately one year, a blood test for phosphatidylethanol (PEth) will be obtained in a different random sample of participants in each group. A secondary outcome will be the results of the PEth test at one year.
Atrial fibrillation burden at one year, quantified by a cardiac device At one year of study participation. Participants who are UCSF Health patients and have an atrial lead or implantable loop recorder will have the option to share heart rhythm data from their respective device with the study team. A secondary outcome will be atrial fibrillation burden, quantified by a cardiac device.
Atrial fibrillation burden at one year, quantified by Apple Watch At one year of study participation. Participants will have the option to connect an Apple Watch to the study mobile app to share data from their device. A secondary outcome will be atrial fibrillation burden, quantified by an Apple Watch.
Trial Locations
- Locations (1)
UCSF Medical Center at Parnassus
🇺🇸San Francisco, California, United States
UCSF Medical Center at Parnassus🇺🇸San Francisco, California, United StatesGregory M Marcus, MD, MASPrincipal InvestigatorGabrielle C Montenegro, BAContact415-502-3053gabby.montenegro2@ucsf.edu