Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Quality of Life as measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) survey
研究概览
简要总结
The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.
Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)
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 (Outcomes Assessor)
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
- •Aged 18 or older at time of consent
- •Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
- •BMI (Body Mass Index) ≥ 27.0
排除标准
- •Permanent Afib (decision has been made not to attempt sinus rhythm)
- •Severe valvular disease
- •Moderate mitral valve stenosis
- •Prior cardiac surgery
- •Presence of implanted cardiac device
- •History of cardiac arrest
- •Left ventricular ejection fraction (LVEF) ≤ 35%
- •Life expectancy < 1 year
- •Non-English speaking
- •Treating clinician deems unsafe for exercise
- •Any other reason that makes patient unsuitable for study at the discretion of the PI
研究组 & 干预措施
Corrie Virtual Atrial Fibrillation Management Program
Multicomponent virtual atrial fibrillation management program
干预措施: Corrie Virtual Atrial Fibrillation Management Program (Combination Product)
Usual Care
Receives usual care. Usual care is defined as care according to the patients care team's standard practice
结局指标
主要结局
Quality of Life as measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT) survey
时间窗: 6 months
Measured by Atrial Fibrillation Effect on Quality-of-Life (AFEQT), which consists of 20 items. Score ranges from 0 to 100 with higher scores signifying better quality of life.
Participants Freedom from documented atrial tachyarrhythmia
时间窗: 91 to 365 days
Freedom from documented atrial tachyarrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) episodes of ≥30 seconds between 91 and 365 days after catheter ablation, on or off antiarrhythmic drugs.
次要结局
- Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT)(365 days)
- AFib burden (percentage of time)(91 to 365 days)
- Participants Freedom from atrial tachyarrhythmia off medication(91 to 365 days)
- Participants Freedom from atrial tachyarrhythmia on or off medications(1 day to 365 days)
- Safety as assessed by hospitalizations, emergency room visits, deaths(1 to 365 days)
- Incidence of hospitalizations, emergency room visits, deaths(1 to 365 days)