Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change in atrial fibrillation severity at one year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •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
排除标准
- •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
研究组 & 干预措施
Contemporary Guideline-Adherence
Participants randomized to Contemporary Guideline-Adherence 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. Alcohol consumption (or abstinence) and AF 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.
干预措施: Contemporary Guideline-Adherence (Behavioral)
Alcohol Abstinence
Participants randomized to Alcohol Abstinence will receive weekly app and text-based messaging encouraging avoidance of all alcohol consumption. Those assigned to this arm will also have the option to opt-in or decline to participate in additional messaging and surveys discouraging the purchase of alcohol triggered by visits to establishments that sell alcohol (bars and liquor stores) for the first month of the study. Alcohol consumption (or abstinence) and AF 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.
干预措施: Alcohol Abstinence (Behavioral)
结局指标
主要结局
Change in atrial fibrillation severity at one year
时间窗: 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.
次要结局
- Atrial fibrillation burden at one year, quantified by Apple Watch(At one year of study participation.)
- Total number of negative urine ethyl glucuronide tests at one year(From baseline to one year of study participation.)
- Results of the phosphatidylethanol test at one year(At one year of study participation.)
- Atrial fibrillation burden at one year, quantified by a cardiac device(At one year of study participation.)