Screening for Atrial Fibrillation With Self Pulse Monitoring in Patients at Increased Risk of Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 526
- 试验地点
- 1
- 主要终点
- Number of participants diagnosed with AF in intervention group who screened positive.
研究概览
简要总结
The goal of this clinical trial is to determine the efficacy of self-pulse monitoring in detecting atrial fibrillation (AF) in adult patients at increased risk of stroke.
The main questions it aims to answer are:
- Is self-screening an effective modality for diagnosis of AF?
- Are there clinical differences and outcomes for patients who self-screen?
Eligible participants will be randomized to either the intervention group or control group. The control group will continue with usual standard of care. Participants randomized to the intervention group will be asked to:
- View an online educational video to teach them the appropriate way to manually check their pulse for irregularities.
- Manually check their pulse for 30 seconds twice daily for 14 days.
- Patients who screen positive for irregularities will be sent a 14-day wearable cardiac monitor to assess for underlying arrhythmias.
Researchers will compare the intervention group to the control group to see if there are clinical differences and outcomes.
详细描述
Participants will be recruited for this study using MyChart recruiting. Participants meeting inclusion criteria will be invited to participate and can respond "interested" or "decline." Participants who respond interested will complete a brief survey to confirm eligibility prior to consenting. One the participant consents, they will be randomized to the self-pulse check/intervention group or control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or greater
- •No known history of atrial fibrillation or atrial flutter
- •Access to MyChart
- •CHA2DS2-VASc sore (described below) >/= 2 (male) or >/=3 (female) based on the following criteria:
- •Two points: Age ≥75, prior stroke
- •One point: Age ≥65-74, congestive heart failure, hypertension, diabetes, vascular disease
排除标准
- •Prior diagnosis of atrial fibrillation or atrial flutter
- •Unable to consent
- •Currently incarcerated
- •Self-pay/uninsured
- •Taking anticoagulation for other medical conditions than atrial fibrillation or atrial flutter
研究组 & 干预措施
Self-Pulse Monitoring Intervention Group
Participants view an educational video instructing them on how to manually check their pulse for irregularities. Participants will be instructed to check their pulse for 30 seconds twice daily for 2 weeks.
干预措施: Self-Pulse Monitoring (Other)
Control Group Standard of Care
The control group will continue with usual care.
结局指标
主要结局
Number of participants diagnosed with AF in intervention group who screened positive.
时间窗: 6 weeks
Participants assigned to the intervention group are instructed on how to manually check their pulse to detect irregularities. Those who screen positive for irregularities will be sent a 14-day wearable cardiac monitor to confirm diagnosis of AF. Diagnosis of AF can also be confirmed by electrocardiogram (ECG) at an outpatient clinic visit.
次要结局
- Total number of participants diagnosed with AF(1-year)
- Amount of time in days to diagnosis of AF from randomization(1-year)
- Number of participants prescribed anticoagulation(1-year)
- Number of participants with stroke, transient ischemic attack (TIA), or systemic embolism(1-year)