eCardiacRehab - a Randomized Controlled Trial on a Hybrid Home-Based Patient-Centered eHealth Programme With Tailored Solutions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
The overall aim of eCardiacRehab trial is to meet rehabilitation needs of patients with coronary artery disease (CAD) regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based hybrid programme. eCardiacRehab address patient- and system level challenges to increase access to cardiac rehabilitation (CR). We give particular attention to older patients, women, and those with comorbidities or mental health challenges. The vision of the hybrid home-based eCardiacRehab programme is to make CR available to all.
eCardiacRehab is a prospective, multicentre randomized open-label blinded end point evaluation (PROBE) trial. The primary endpoint is a hierarchical composite endpoint using a win-ratio framework combining cardiovascular (CV) death, unplanned contacts to the Emergency Department (ED) for observation or admission (>24 hours) for CV disease, and quality of life. Inclusion criteria are adult Scandinavian speaking patients (≥ 18 years) who have a Norwegian national identification number, with CAD treated with Percutaneous Coronary Intervention (PCI), are living at home, and have internet available to them and providing signed informed consent. Exclusion criteria are patients with severe aortic stenosis, severe arrhythmias, expected lifetime less than one year as determined by study personnel, otherwise clinically unstable, not fully revascularized, awaits PCI or coronary artery bypass graft operation (CABG) or inability to comply with the study protocol due to any physical disability, somatic disease, cognitive impairment or mental health challenges as determined by study personnel.
详细描述
The primary objective is to test whether a hybrid CR programme (the eCardiacRehab) reduces the risk of CV death and CV related ED contacts, and improves quality of life compared to usual care in patients with CAD treated with PCI.
The secondary and exploratory objectives (planned for the main study) are:
- To assess whether eCardiacRehab improves each of the components of the primary endpoint separately compared to usual care.
- To assess clinical outcomes associated with eCardiacRehab in the following subgroups: age, sex (men vs. women), hypertension (yes vs. no), multimorbidity (yes vs. no), mental health challenges (yes vs. no).
- To study whether eCardiacRehab reduces the total number of ED contacts compared to usual care.
- To study whether eCardiacRehab reduces the risk of all-cause death compared to usual care.
- To assess whether eCardiacRehab improves long-term medication adherence to cardiometabolic medications (e.g. antiplatelets, lipid lowering drugs, antihypertensive, and antidiabetics) in patients after PCI utilizing data from the Norwegian Prescribed Drug Registry, and by patients' self-report.
- To assess whether participation in eCardiacRehab improves the total number of CV risk factors.
- To assess whether participation in eCardiacRehab is non-inferior to conventional, in-person CR among the subset of usual care participants who attend standard place-based CR.
Other secondary objectives (for eCardiacRehab sub-studies) are:
- To conduct a cost-utility study, from a societal and healthcare system perspective perspective; cost per QALY. Cost categories include i) the intervention; ii) inpatient/outpatient visits; iii) community-based healthcare; iv) medications; v) patient-borne costs and vi) production loss due to sick leave. Further, to estimate cost-effectiveness acceptability curves to estimate the probability that the intervention is cost-effective at different willingness to pay for a unit of the outcome measure.
- To study whether eCardiacRehab affects the following patient-reported outcomes: quality of life, angina, anxiety, depression, sleep status, health literacy and eHealth literacy, frailty status, fatigue, continuity of care, and adherence to healthy lifestyle recommendations (physical activity, tobacco use, sleep, diet).
- To study whether eCardiacRehab improves objectively measured cardiorespiratory fitness (VO2peak), intensity minutes (activity tracker) and self-reported physical activity and exercise.
- To study whether eCardiacRehab improves body composition (visceral fat, muscle mass, body fat, BMI).
- To study whether eCardiacRehab improves change in number of controlled risk factors.
- To study whether eCardiacRehab improves low-density lipoproteins.
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 (Outcomes Assessor)
盲法说明
Data Analysts: Researchers responsible for analyzing the data are blinded to group assignments to prevent bias in data interpretation.
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
- •Adult Norwegian (or Scandinavian) speaking patients (≥ 18 years) who have a Norwegian national identification number
- •With coronary artery disease after percutaneous coronary intervention
- •Living at home
- •Have internet available
- •Provide signed informed consent
排除标准
- •Patients with cognitive impairment that may interfere with the ability to comply with the study protocol
- •Severe aortic stenosis
- •Severe arrhythmias
- •Expected lifetime less than one year as determined by study personnel
- •Otherwise clinically unstable
- •Not fully revascularized
- •Awaits percutaneous coronary intervention or coronary artery bypass graft surgery
- •Inability to comply with the study protocol due to any physical disability, somatic disease, or mental problems as determined by study personnel
研究组 & 干预措施
Usual care
No intervention
eCardiacRehab
Digital cardiac rehabilitation
干预措施: eCardiacRehab (Other)