Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Atrial Fibrillation (Paroxysmal); Atrial Fibrillation (AF)

Treatments: Behavioral: Alcohol Consumption Randomized Instructions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06754176

R01AA022222 (U.S. NIH Grant/Contract)

24-41856

Details and patient eligibility

About

The goal of this study is to assess the short-term effects of minimal and moderate drinking on atrial fibrillation (AFib) episodes in a real-world population diagnosed with 'come-and-go'/paroxysmal AFib. The question it aims to answer is:

Is there a greater occurrence of AFib episodes when participants are allowed to consume alcohol according to random assignment?

Participants will:

• Be given daily random assignments to avoid or not to avoid alcohol
• Wear an adhesive electrocardiographic (ECG) heart monitor
• Wear a wrist-worn fitness tracker
• Wear an anklet transdermal alcohol monitor
• Wear an adhesive glucose monitor
• Complete morning and evening surveys daily

Participants may be compensated up to $50 for full completion of the study. This study can be done in-person or remote.

Full description

This study is a case-crossover randomized trial, where each participant will be instructed to avoid or not avoid drinking alcohol on randomly assigned days during a 14-day monitoring period. Participants will also wear an external ECG monitor, an alcohol monitor, a continuous glucose monitor, and a fitness tracker for up to two weeks while utilizing a mobile application to receive daily instructions/reminders on drinking and short surveys. The investigators will compare participant self-report of alcohol consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the immediate relationship between drinking alcohol and heart rhythm. A total of 100 participants will be enrolled.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Comfortable reading and writing in English
• Have a smartphone and willing and able to use the Eureka mobile application
• Currently diagnosed with paroxysmal AFib without a plan to change their AFib management during the two-week monitoring period
• At least one episode of AFib in the past month OR, in the judgement of a healthcare provider, could potentially have one episode of AF in the next month
• Drank alcohol at least 1 day/week on average in the past month
• Willing and able to be randomly assigned daily to avoid or not avoid drinking alcohol over a 2-week period
• Willing and able to provide written informed consent

Exclusion Criteria

• Only post-operative AFib
• Greater than 40% ventricular pacing
• History of alcohol addiction or abuse determined by self-reported history or AUDIT-C score
• Intolerance to alcohol
• History of liver disease
• Currently incarcerated
• Currently pregnant or trying to get pregnant

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Alcohol Non-Avoidance Case-Crossover Arm

Experimental group

Description:

On a given day of the 14-day study period, participants may be randomly assigned to not avoid consuming alcohol. All participants will be instructed that any alcohol consumed should not be more than 2 drinks in a 24 hour period for men and not more than 1 drink in a 24 hour period for women. The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row. Participants will press a button on their continuously recording ECG monitor to time-stamp every alcohol drink consumed.

Treatment:

Behavioral: Alcohol Consumption Randomized Instructions

Alcohol Avoidance Case-Crossover Arm

Experimental group

Description:

On a given day of the 14-day study period, participants may be randomly assigned to avoid consuming alcohol. The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row.

Treatment:

Behavioral: Alcohol Consumption Randomized Instructions