mHealth-CArdiac REhabilitation for INOCA (INOCA-CARE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change in Seattle Angina Questionnaire (SAQ) score
研究概览
简要总结
This is a multi-site phase II, 2:1 pragmatic randomized trial of 250 participants within the NYU Langone Health (NYULH) and Emory University Medical Center system to evaluate mobile health cardiac rehabilitation (mHealth-CR) in patients who meet clinical criteria for INOCA (ischemia and no obstructive coronary disease on imaging). Participants will be randomized to mHealth-CR or usual care. The study intervention takes place for 3 months which is the time period for most traditional CR programs.
The overall study goals are threefold: 1) to evaluate whether an mHealth-CR intervention that includes activity tracking, weekly counseling, and exercise documentation, improves health status (i.e., symptoms, function, and quality of life) in patients with INOCA at 3 months; 2) to evaluate effects of the mHealth-CR intervention vs. usual care on physical activity and exercise capacity, general health status, and depressive symptoms (secondary endpoints). We will also evaluate effects on primary and secondary outcomes at 6 months and 1 year; and 3) to characterize engagement and elucidate any factors that limit engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18 and over
- •Diagnosis of Ischemia with Non-Obstructive Coronary Arteries (INOCA) based on evidence of ischemia and/or ischemic symptoms, plus non-obstructive Coronary artery disease (CAD) on computed tomography (CT) or invasive angiography
排除标准
- •Seattle Angina Questionnaire (SAQ) = 100
- •Non-ambulatory
- •Moderate or severe cognitive impairment
- •Unable/willing to provide consent
- •Incarcerated
- •Unable to use mHealth
- •Severe osteoarthritis or joint replacement within 3 months
- •Parkinsons disease or other movement disorders
- •Regular use of walker
- •Life expectancy < 12 months
- •Clinical judgement concerning other safety or non-adherence issues
- •Unable to read and communicate in English since the app content is currently only available in English.
结局指标
主要结局
Change in Seattle Angina Questionnaire (SAQ) score
时间窗: Baseline, Month 12
The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
Weekly percent completion of the mHealth-CR program
时间窗: Month 3
Weekly engagement will be measured as the fraction of the following elements completed each week: exercise therapy-directed activities, daily entry of exercise data and rated perceived exertion (RPE); completed weekly phone call with exercise therapist; at least one communication with exercise therapist (outside weekly phone call); reviewing educational video/text (which will vary by week). Competition will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all activities completed) incorporating values for each activity.
次要结局
- Change in step count(Week 1, Month 12)
- Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score(Baseline, Month 12)
- Change in visual analogue scale (VAS) score(Baseline, Month 12)
- Change in patient Health Questionnaire - 8 Items (PHQ-8) score(Baseline, Month 12)
- Change in exercise time on treadmill stress test(Baseline, Month 3)