Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Presence or Absence of Discrete Atrial Fibrillation Episodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Alcohol Non-Avoidance Case-Crossover Arm
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.
干预措施: Alcohol Consumption Randomized Instructions (Behavioral)
Alcohol Avoidance Case-Crossover Arm
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.
干预措施: Alcohol Consumption Randomized Instructions (Behavioral)
结局指标
主要结局
Presence or Absence of Discrete Atrial Fibrillation Episodes
时间窗: 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.
次要结局
- As-Treated Relationships versus the Presence of AFib(2 weeks)
- Daily Glucose Levels(2 weeks)
- Step Counts(2 weeks)
- Sleep Duration(2 weeks)