Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Presence or Absence of Discrete Atrial Fibrillation Episodes
Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Presence or Absence of Discrete Atrial Fibrillation Episodes
Time Frame: 2 weeks
Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be the presence (versus absence) of at least one AFib episode on randomly assigned drinking versus non-drinking days.
Secondary Outcomes
- As-Treated Relationships versus the Presence of AFib(2 weeks)
- Daily Glucose Levels(2 weeks)
- Step Counts(2 weeks)
- Sleep Duration(2 weeks)