Application for Self-Monitoring of Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Percentage of subjects who completed all tasks in the application.
研究概览
简要总结
Patients who recently suffered a heart attack will use a smart-phone/computer application during cardiac rehabilitation to reduce their risk of a future attack, their re-hospitalizations, their cost of care, and increase their quality of life.
详细描述
The study will consist of two phases - an initial feasibility trial (Phase 1), followed by a randomized clinical trial (Phase 2). Once the Phase 1 trial is evaluated, Phase 2 will be implemented.
Phase 1 will consist of up to 35 participants to ensure that the software application is user-friendly, properly stores pertinent data, and has no technical glitches. All participants in Phase 1 will have access to the software application and will be asked to complete online questionnaires, at baseline and post cardiac rehab, to assess their quality of life and also their satisfaction with their care and the software application itself.
Phase 2 will consist of 65 participants. These participants will be randomized to either 1) Cardiac Rehab (CR) alone along with answering questionnaires regarding quality of life and satisfaction of care or 2) CR along with the software application and the quality of life, satisfaction of care and software application questionnaires. All participants (both Phase 1 and Phase 2) enrolled into the study will be status-post percutaneous coronary intervention (PCI). The potential participants will be asked to participate while still in the hospital and will be approached as soon as possible after agreeing to participate in CR,. The participants who enroll in Phase 2 will be randomized prior to discharge from the hospital.
All participants in Phase 1 and those in Phase 2 who randomize to the software application will be instructed on the use of either the desktop or smart-phone version of the software application. Baseline information, including participant name, date of birth, email address, and phone number, will be gathered from the participant at that time, and all characteristics will be entered by the participant and study coordinator into their own account in the application.
The study will follow all Phase 1 participants and those in Phase 2 who randomize to the software application for three months after hospital dismissal and evaluate the following:
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently underwent PCI.
- •Are eligible for enrollment to the Cardiovascular Health Clinic (CVHC)
- •Do not have any physical impediments to physical activity
- •Do not have any impediments to physically attending the Mayo Clinic's CVHC
- •They are willing to incorporate the software application into their CR
- •They must have access to the internet
排除标准
- •- They are unable or unwilling to enroll in CR
- •They are unable to physically attend Mayo Clinic's CVHC CR Program
- •They are unwilling to incorporate the Personal Health Assistant into their CR
研究组 & 干预措施
Self Monitoring of Software Application
log into self monitoring software application from a home computer. Log on 3-4 times weekly for 12 weeks for important reminders, care tips and educational materials.
干预措施: Self Monitoring Software Application (Device)
No Intervention
No Intervention
结局指标
主要结局
Percentage of subjects who completed all tasks in the application.
时间窗: Baseline to 3 months
These data will provide the best summary of usability of the application.
次要结局
- User-reported satisfaction with application.(Baseline to 3 months)