Applying Telemedicine Technologies in a Novel Model of Organizing and Implementing Comprehensive Cardiac Rehabilitation in Heart Failure Patients - TELEREH-HF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 850
- 试验地点
- 5
- 主要终点
- days alive and out of hospital
研究概览
简要总结
Applying modern technology of data collecting, monitoring, transmitting and analyzing in order to implement a novel (hybrid) model of comprehensive home-based cardiac rehabilitation in heart failure patients.
详细描述
Heart failure (HF) epidemic is an aggressively developing phenomenon, stimulated by developing civilization and generating worrying economic and social effects. Early comprehensive cardiac rehabilitation (CCR) is an accepted method of preventing and treating adverse cardiac events, which allows for care cost reduction. In Poland, CCR availability is highly unsatisfactory (around 8%) and unacceptably varied (0.5-70%). With the existing organization and technical background, improving this situation seems impossible. Project objective: To apply telemedicine technologies to implement a novel model of home-based CCR in HF patients.
The program, performed in six centers, will comprise 850 HF patients (randomization 1:1), in NYHA class I-III, EF≤40%, clinically stable, after a hospitalization incident. The study group patients will undergo a 9-week rehabilitation program consisting of two stages: Stage I - preliminary (one week at stationary ward), Stage II - main (8 weeks of home-based telerehabilitation). The primary end-point (days alive and out of hospital) will be assessed during a 24-month follow-up in both groups. The project will enable early secondary prevention in the population of people with HF to be implemented. It will be achieved via:
- Novel concept - "From Hospital To Home"
- Novel technology - telemedicine
- Novel method of CCR implementation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •patients of either sex with any aetiology of left ventricular systolic HF [as defined in the European Society of Cardiology (ESC) guidelines]
- •with a left ventricular ejection fraction (LVEF) ≤40% on echocardiography;
- •in New York Heart Association (NYHA) class I, II or III;
- •who are to have had a hospitalization incident, be stable clinically (a patient does not need intravenous medication or has not had therapy modified for at least 7 days);
- •who has no contraindications to undergo cardiopulmonary exercise test and
- •who are able to exercise using the new model of home-based telerehabilitation.
排除标准
- •NYHA class IV;
- •unstable angina;
- •unstable clinical status
- •a history of acute coronary syndrome within the last forty days in patients with LVEF ≤35%; percutaneous angioplasty (PCI) within the last 2 weeks, coronary artery bypass grafting within the last 3 months, or initiation of cardiac resynchronization therapy (CRT-P, CRT-D) and/or implantable cardioverter-defibrillator (ICD) or pacemaker within the last six weeks;
- •lack of ICD, CRT-P or CRT-D therapy despite the indications for implantation according to ESC guidelines;
- •intracardiac thrombus
- •rest heart rate (HR) >90/min,
- •tachypnoea >20 breaths per minute
- •symptomatic and/or exercise-induced cardiac arrhythmia or conduction disturbances;
- •acute myocarditis and/or pericarditis
- •valvular or congenital heart disease requiring surgical treatment;
- •hypertrophic cardiomyopathy;
- •severe pulmonary disease;
- •uncontrolled hypertension;
- •anemia (haemoglobin <11.0 g/dL);
- •physical disability related to severe musculoskeletal or neurological problems;
- •recent embolism;
- •thrombophlebitis;
- •acute or chronic inflammatory disease;
- •acute or chronic decompensated non-cardiac diseases (thyreotoxicosis, uncontrolled diabetes)
- •active malignant neoplastic diseases with survival prognosis below 2 - 5 years;
- •orthotropic heart transplant in anamnesis;
- •aortic aneurysm;
- •severe psychiatric disorder; and
- •patient's refusal to participate.
研究组 & 干预措施
telerehabilitation group
1 week hospital rehabilitation and 8 weeks home-based telerehabilitation and telemanagement (including HomeMonitoring)
干预措施: home-based telerehabilitation (Other)
control group
Patients qualified to the control group will undergo a 9-week procedure appropriate to their clinical condition/status standardized for a particular center (usual care).
结局指标
主要结局
days alive and out of hospital
时间窗: up to 2 years
次要结局
未报告次要终点
研究者
Dr Ewa Piotrowicz
MD, PhD
National Institute of Cardiology, Warsaw, Poland