iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Rate of Recurrence of Atrial Arrhythmias
研究概览
简要总结
Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly, is a major health problem. The long-term goal of this project is to use a personal, mobile heart monitor to help patients better recognize recurrent AF and improve patients' ability to better manage their condition. A total of 300 patients with a history of AF will be included in the study, with 150 patients receiving an iPhone with the mobile monitoring device and educational text messaging and the remaining 150 patients continuing with their regular medical care. Each patient will be included in the intervention period for 6 months. The rate of recurrent AF and treatments meant to manage AF and other heart conditions will be determined for both groups. Patients in both groups will complete a series of questionnaires at the start and end of the 6 month study period to look at differences in quality of life and knowledge of AF.
详细描述
This study is a prospective randomized control trial with 1:1 randomization of 300 patients to either use the AliveCor device and receive behavioral altering motivational text messaging OR continue with usual care. The sample size and power was based on the test of the difference in AF detection rates between the intervention group and the control group in a similarly design pilot study. In the preliminary data there were 4 episodes of AF during the follow-up of 12 patients or a detection rate of 0.33 vs. a detection rate of 8% among controls. The detection window in this study as the time period from randomization to the 6-month follow-up will be defined. All patients' clinical records will be reviewed every month (via charts and/or internal and external electronic medical record systems) up until month 6 for initiations/changes in treatments targeting AF. A recurrence of AF in the chart and any related therapies that are initiated as a result of electrocardiogram (ECG) findings through usual cardiac care or from the AliveCor™ Heart Monitor will be specifically looked at. Changes in cardiovascular measures (blood pressure, glucose control, etc.) will be compared between groups. The effect of participating in the intervention, which includes targeted text messaging on AF knowledge and cardiovascular behavior change will be determined by comparing the change in AF knowledge scales from baseline to 6 months. This study will also measure and compare the incidence of documented AF in both groups, changes in prescribed treatment by healthcare providers over the 6-month period, and the relationship of the intervention to changes in cardiac measures and quality-adjusted life-years (QALYs) measured at baseline and 6 months. A biannual time period was chosen to capture AF redetection, changes in AF treatment, and self-reported quality of life based on other studies that have shown biannual time-points as most appropriate for collecting the proposed study endpoints.
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
- Single (Investigator)
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
- •Males and females (English or Spanish speaking) age ≥ 18 years with a history of AF in the last 30 days that was treated with normal rhythm restored.
- •Ability to successfully use the AliveCor™ Heart Monitor, capture a baseline ECG, and transmit on the day of enrollment
- •Demonstrated ability to receive, read, and send a text messages on the day of enrollment
- •Willingness to complete the study questionnaires at baseline and 6 months
排除标准
- •Documented permanent (chronic) AF
- •Patient found to be in AF or other rhythm disturbances on the day of enrollment (i.e., they need to be clinically evaluated or treated)
- •Unwillingness have their clinical data collected over the study period
- •Unwillingness to receive and read cardiovascular text messaging three times a week.
结局指标
主要结局
Rate of Recurrence of Atrial Arrhythmias
时间窗: Six months
Examine the rate of recurrent atrial arrhythmias between the intervention and control group during the study period. The investigators will define and calculate recurrent AF detection rate as the ratio of the number of recurrent AF episodes to the number of person-months of follow-ups.
Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia
时间窗: 6 months
Number of intervention and control group patients with recurrent atrial arrhythmia who received treatment for recurrent atrial arrhythmia
Time to Treatment for Recurrence of Atrial Arrhythmia
时间窗: Six months
Time to treatment for recurrence of atrial arrhythmia from detection of arrhythmia to 6 months
次要结局
- Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups(Six Months)
- Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months(Six months)
研究者
Suzanne Bakken
Alumni Professor of the School of Nursing
Columbia University