E-health Intervention for Cardiac Rehabilitation: Pilot Implementation and Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Patient Activation
研究概览
简要总结
Cardiac rehabilitation (CR) is designed to increase healthy behaviours (e.g. physical activity, healthy eating, smoking abstinence) and reduce risk factors (e.g. high blood pressure & cholesterol) in order to improve quality of life and health among people with heart disease. Unfortunately, few patients attend CR, often reporting several barriers to access including travel distance, parking fees and lack of time. Advances in technology have the potential to improve accessibility and delivery of CR programs, and improve patient empowerment. The University of Ottawa Heart Institute has developed an e-health program called the Virtual Cardiac Rehabilitation Program (VCRP); an online cardiovascular health management system (website & Smartphone app) that provides strategies for the control and management of risk factors. The goals of VCRP are to: empower and educate patients; foster better communication between patients and their health care team; stimulate shared decision making; and, facilitate care coordination leading to better health outcomes. The VCRP provides patients with: real-time access to their health information, as well as tracking of risk behaviours and factors through integration with devices; a wellness plan; access to a personal on-line health coach; goal-setting notifications; on-line community forums; and, circle of care access to information. The aim of this project is to evaluate the effects of VCRP (with integrated fitness tracker) compared to a standard, home-based CR program. The study will look at changes in: patient empowerment; health behaviours; risk factors; quality of life; clinical outcomes; and, costs. The study will improve our understanding of: patient and provider needs; program usability; and shared decision-making. Results will inform the use of e-health programs such as VCRP into healthcare settings to improve patient empowerment, shared decision-making, and the ability to integrate wearable monitors to improve health behaviours.
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
- Single (Care Provider)
盲法说明
The facilitators will not know that the participants are part of the study. Participants will know which group they are allocated to as they are aware of both groups (described in the consent form).
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
- •Patient was hospitalized at the University of Ottawa Heart Institute (UOHI);
- •Patient has stable Coronary Heart Disease (CHD) or valvular disease;
- •Patient has been referred to Cardiac Rehabilitation (CR) and is a candidate an offsite program;
- •Patient has access to and regularly uses a smart phone, tablet or computer with Internet access;
- •Patient is ≥ 18 years of age (the age of consent in Ontario);
- •Patient is able to read and understand English or French (programs are available in both languages);
- •Patient is eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences [ICES]);
排除标准
- •Patient was hospitalized for heart failure, congenital heart disease, transplant or arrhythmia within the last 6 months;
- •Patient, in the opinion of the medical advisor (Dr. Andrew Pipe), manifests illness that would preclude participation in the interventions (e.g. cognitive impairment, active drug or alcohol dependence).
结局指标
主要结局
Patient Activation
时间窗: Baseline - 22 weeks
Patient activation will be measured by the Patient Activation Measure (PAM) questionnaire.This 10-item tool assesses the degree to which a patient is engaged or disengaged with their health and how likely they are to self-manage it.The total score of the tool classifies a participant into one of 4 categories; disengaged and overwhelmed (level 1), becoming aware but still struggling (level 2), taking action (level 3) and maintaining behaviors and pushing further (level 4). Higher levels mean participants are becoming better at, or have fully begun to self-manage their health behaviors.
次要结局
- Triglycerides(Baseline - 22 weeks)
- Generic Quality of Life(Baseline - 22 weeks)
- Cost of Intervention(Fiscal year 2017 through study completion.)
- Tobacco smoking(Baseline - 22 weeks)
- Blood pressure(Baseline - 22 weeks)
- Glycated hemoglobin (A1C)(Baseline - 22 weeks)
- Waist circumference(Baseline - 22 weeks)
- Health Related Quality of Life(Baseline - 22 weeks)
- Physical activity(Baseline - 22 weeks)
- Low density lipoprotein cholesterol (LDL-C)(Baseline - 22 weeks)
- Total cholesterol (TC)(Baseline - 22 weeks)
- Medication adherence(Baseline - 22 weeks)
- Dietary behaviors(Baseline - 22 weeks)
- High density lipoprotein cholesterol (HDL-C)(Baseline - 22 weeks)
- Clinical outcomes - Re-hospitalization(Baseline - 52 weeks)
- Clinical outcome - mortality(Baseline - 52 weeks)
- Clinical outcome - Health care utilization - Number of emergency room and physician visits(Baseline - 52 weeks)