Assessing the Ability of KardioPAC, a Digital Tool, to Facilitate Lifestyle Change in Participants Enrolled in a Cardiac Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Delta change in minutes per week of moderate physical activity between baseline and end of study between SOC and intervention as measured by actigraphy.
研究概览
简要总结
The purpose of this study is to sustain regular physical activity, improve health-related quality of life, improve resting blood pressure, improve anthropometrics, and improve adherence to prescribed cardiac rehabilitation sessions among individuals referred for cardiac rehabilitation (CR). Numerous studies show that CR improves clinical outcomes in cardiovascular disease (CVD). Exercise as a reliable adjunctive intervention, however, remains limited due to poor short- and long-term adherence. This proposed study will examine the effectiveness of the Kura Care KardioPac digital application plus CR to significantly sustain exercise adherence among CR patients, as compared to standard of care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to the University of California San Diego Health Cardiac Rehabilitation Center for 36-72 sessions of intensive cardiac rehabilitation for one of the following medical conditions: myocardial infarction, coronary artery bypass surgery, stable angina, heart valve repair or replacement, coronary angioplasty or stenting, congestive heart failure, heart transplant, or peripheral arterial disease
- •Able to give informed consent in English
- •Able to perform study assessments as described
- •Resting BP<180/110 mmHg
- •Able to perform light to moderate exercise
- •Have not had a fall during the previous 6 months resulting in an injury
- •Clinical staff's permission to participate, including their assessment that participant is a good candidate for this research study
- •Ability to complete written or app-based surveys
- •Owns an Apple or Android mobile telephone capable of downloading and running the app
排除标准
- •Referred to CR following Ventricular Assist Device procedure
- •Angina not adequately managed with nitrates
- •Oxygen-dependent Chronic Obstructive Pulmonary Disease
- •Recent stroke or significant cerebral neurologic impairment that would interfere with participation.
- •Unable to operate a BP device
研究组 & 干预措施
Cardiac Rehabilitation + KardioPAC (CR+KardioPAC)
干预措施: KardioPAC Mobile Application (Behavioral)
Cardiac Rehabilitation + KardioPAC (CR+KardioPAC)
干预措施: Standard of Care (Other)
Standard-of-care cardiac rehabilitation (SOC CR)
干预措施: Standard of Care (Other)
结局指标
主要结局
Delta change in minutes per week of moderate physical activity between baseline and end of study between SOC and intervention as measured by actigraphy.
时间窗: ~4 Months
Assess the ability of CR + KardioPAC as compared to standard-of-care CR to change the activity level of participants.
次要结局
- Delta change in METs (Metabolic Equivalents of Task), a measure of the amount of oxygen consumed during activity compared to resting oxygen consumption.(~4 Months)
研究者
Pam Taub, MD
Director of Step Family Foundation Cardiovascular Rehabilitation and Wellness Center Professor of Medicine
University of California, San Diego