Feasibility Study to Improve Atrial Fibrillation Outcomes Using a Digital Application for Cardiovascular Risk Reduction: Precursor to a Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Percentage of Emails Opened and Clicked Through
研究概览
简要总结
The pilot portion of this study is to determine the feasibility of utilizing AF CARE to provide lifestyle modification support to patients with atrial fibrillation (AF).
The prospective, RCT portion of this study compare cardiovascular risk factors (CVRF), AF knowledge, AF Symptom Severity and Burden, and QOL between and within the wait list group and the AF CARE group at baseline, 3, 6, and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •BMI > 28 kg/m2 AND one additional CVRF using LS7
- •Access and willingness to engage in digital technology
- •Has a valid email address and a cell phone number
- •Able to ambulate
- •Able to speak/read English
排除标准
- •Class III/IV heart failure
- •MI or cardiac surgery in prior 3 months
- •Severe renal/hepatic disease
- •Active malignancy
- •Current/recent (within 6 months) enrollment in weight loss program
结局指标
主要结局
Percentage of Emails Opened and Clicked Through
时间窗: Baseline through month 6
Percentage of emails opened, and of those opened, the percentage of emails clicked through
Percentage of Text Messages That Were Reviewed
时间窗: Baseline through month 6
Cardiovascular Risk Factor Score
时间窗: Baseline, month 3, month 6, and month 12
The American Heart Association Life Simple 7 (LS7) is a calculated score using lab values, biometric measurements, and patient dietary responses. Score range: 0 to 10; 0 = most risk, 10 = least risk
次要结局
- Change From Baseline in AF Symptom Severity(Baseline, month 3, month 6, and month 12)
- Change From Baseline in AF Symptom Burden(Baseline, month 3, month 6, and month 12)
- Change From Baseline in Knowledge Related to Atrial Fibrillation(Baseline, month 3, month 6, and month 12)
- Change From Baseline in AF Quality of Life Score(Baseline, month 3, month 6, and month 12)
研究者
Paul Wang
Director, Stanford Electrophysiology and Arrhythmia Service
Stanford University