Applying Telemedicine in a Model of Implementing Cardiac Rehabilitation in Heart Failure Patients (TELEREH-HF)

March 9, 2018 updated by: Dr Ewa Piotrowicz, Institute of Cardiology, Warsaw, Poland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland, 80-210
        • Gdanski Uniwersytet Medyczny
      • Warsaw, Poland, 04-628
        • Institute of Cardiology
      • Warsaw, Poland, 02-097
        • Warsaw Medical University; Department of Cardiology
      • Zabrze, Poland, 41-800
        • Slaskie Centrum Chorob Serca
      • Łódź, Poland, 90-647
        • Klinika Chorób Wewnętrznych i Rehabilitacji Kardiologicznej

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
days alive and out of hospital
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiology, Warsaw, Poland

Collaborators

National Center for Research and Development, Poland

Investigators

  • Study Director: Ewa Piotrowicz, MD, Institute of Cardiology, Telecardiology Center, Warsaw, Poland
  • Study Chair: Grzegorz Opolski, Prof, Warsaw Medical University, Department of Cardiology, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRATEGME1/233547/13/NCBR/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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