Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Participants Who Continue Study Participation at 12 Weeks
研究概览
简要总结
The overall objective of this proposal is to evaluate the feasibility 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 feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).
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
- •18 years or older
- •Non- valvular Paroxysmal Atrial Fibrillation
排除标准
- •Non-English speaking
- •Has previously been evaluated by a cardiologist or electrophysiologist
- •Mitral Stenosis
- •Presence of Artificial Heart Valve
- •Severe valvular disease (any)
- •Physical disability that would preclude technology use, safe and adequate exercise performance
- •Hearing or Visual Impairment that would preclude technology use
- •History of fall one or more times in the last year
- •Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of >25 mmHg
- •Known aortic dissection
- •Severe resting arterial hypertension (SBP >200 mmHg or diastolic BP >110mmHg) upon enrollment (obtained during clinic visit)
- •Mental impairment leading to inability to cooperate with study procedures
- •Untreated high degree atrioventricular block
- •Atrial fibrillation with rapid ventricular rate (Resting heart rate at enrollment visit >110) upon enrollment (obtained during clinic visit)
- •History of cardiac arrest, sudden death
- •MI or cardiac surgery complications of cardiogenic shock and/or congestive heart failure (CHF) and/or signs/symptoms of post-procedure ischemia
- •Left ventricular ejection fraction <40%
- •Clinically significant depression
- •Presence of implanted cardiac device
- •Incomplete revascularization procedure
- •Pregnancy
- •Previous open-heart surgery
- •Unsafe to participate in the program as per treating clinician
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
Number of Participants Who Continue Study Participation at 12 Weeks
时间窗: 12 weeks
Feasibility assessed by retention at 12 weeks (number of individuals who continue study participation (defined by App interaction, Coaching call participation or follow up survey completion)
次要结局
- Body Mass Index (BMI)(12 weeks)
- Atrial Fibrillation (AF) Severity as Assessed by the Atrial Fibrillation Severity Scale(12 weeks)
- Stress Level as Assessed by the Perceived Stress Score(12 weeks)
- Quality of Life as Assessed by the Atrial Fibrillation Effect on Quality-of-Life(12 weeks)
- Depressive Symptoms as Assessed by the Patient Health Questionnaire 8(12 weeks)
- Alcohol Use as Assessed by the Alcohol Use Disorders Identification Test(12 weeks)
- Body Mass Index (BMI)(12 weeks)
- Physical Activity as Assessed by the Rapid Assessment of Physical Activity(12 weeks)
- Satisfaction With Intervention(12 weeks)
- Anxiety as Assessed by the Generalized Anxiety Disorder 7 Score(12 weeks)
- Diet as Assessed by the Rate Your Plate (RYP) Scale(12 weeks)
- Skills in Applying Electronic Health Information to Health Problems(12 weeks)
- Blood Pressure(12 weeks)