Applying Telemedicine in a Model of Implementing Cardiac Rehabilitation in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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

Official Title
-----------------
Applying Telemedicine Technologies in a Novel Model of Organizing and Implementing Comprehensive Cardiac Rehabilitation in Heart Failure Patients - TELEREH-HF

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Other: home-based telerehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telerehabilitation group<br>1 week hospital rehabilitation and 8 weeks home-based telerehabilitation and telemanagement (including HomeMonitoring) | Other: home-based telerehabilitation<br>* Patients qualified to the study group will undergo, at five medical units a 9-week program of early hybrid, comprehensive cardiac telerehabilitation.<br>|
| No Intervention: control group<br>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). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days alive and out of hospital |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telerehabilitation, Home Monitoring, Heart Failure