E-health Intervention for Cardiac Rehabilitation
追踪信息 | |||
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首次提交日期 ICMJE | April 17, 2018 | ||
首次发布日期e ICMJE | October 4, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | October 15, 2018 | ||
预计主要完成日期 | June 1, 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Patient Activation[ Time Frame: 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. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | E-health Intervention for Cardiac Rehabilitation | ||
正式标题 ICMJE | E-health Intervention for Cardiac Rehabilitation: Pilot Implementation and Feasibility | ||
简要概况 | 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. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: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). 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
156 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | December 31, 2020 | ||
预计主要完成日期 | June 1, 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: 1. Patient was hospitalized at the University of Ottawa Heart Institute (UOHI); 2. Patient has stable Coronary Heart Disease (CHD); 3. Patient has been referred to Cardiac Rehabilitation (CR) and is a candidate an offsite program; 4. Patient has access to and regularly uses a smart phone, tablet or computer with Internet access; 5. Patient is ≥ 18 years of age (the age of consent in Ontario); 6. Patient is able to read and understand English or French (programs are available in both languages); 7. Patient is eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences [ICES]); Exclusion Criteria: 1. Patient was hospitalized for heart failure, congenital heart disease, transplant or arrhythmia within the last 6 months; 2. 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). | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Canada | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | Ottawa Heart Institute Research Corporation | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |