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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
home-based telerehabilitation
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Heart Failure focused on measuring Telerehabilitation, Home Monitoring, Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gdański Uniwersytet Medyczny
  • Warsaw Medical University; Department of Cardiology
  • Institute of Cardiology
  • Slaskie Centrum Chorób Serca
  • Klinika Chorób Wewnętrznych i Rehabilitacji Kardiologicznej

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

telerehabilitation group

control group

Arm Description

1 week hospital rehabilitation and 8 weeks home-based telerehabilitation and telemanagement (including HomeMonitoring)

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).

Outcomes

Primary Outcome Measures

days alive and out of hospital

Secondary Outcome Measures

Full Information

First Posted
August 3, 2015
Last Updated
March 9, 2018
Sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborators
National Center for Research and Development, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT02523560
Brief Title
Applying Telemedicine in a Model of Implementing Cardiac Rehabilitation in Heart Failure Patients
Acronym
TELEREH-HF
Official Title
Applying Telemedicine Technologies in a Novel Model of Organizing and Implementing Comprehensive Cardiac Rehabilitation in Heart Failure Patients - TELEREH-HF
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborators
National Center for Research and Development, Poland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Telerehabilitation, Home Monitoring, Heart Failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
850 (Actual)

8. Arms, Groups, and Interventions

Arm Title
telerehabilitation group
Arm Type
Experimental
Arm Description
1 week hospital rehabilitation and 8 weeks home-based telerehabilitation and telemanagement (including HomeMonitoring)
Arm Title
control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
home-based telerehabilitation
Intervention Description
Patients qualified to the study group will undergo, at five medical units a 9-week program of early hybrid, comprehensive cardiac telerehabilitation.
Primary Outcome Measure Information:
Title
days alive and out of hospital
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Piotrowicz, MD
Organizational Affiliation
Institute of Cardiology, Telecardiology Center, Warsaw, Poland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Grzegorz Opolski, Prof
Organizational Affiliation
Warsaw Medical University, Department of Cardiology, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Gdański Uniwersytet Medyczny
City
Gdańsk
ZIP/Postal Code
80-210
Country
Poland
Facility Name
Warsaw Medical University; Department of Cardiology
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Slaskie Centrum Chorób Serca
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Klinika Chorób Wewnętrznych i Rehabilitacji Kardiologicznej
City
Łódź
ZIP/Postal Code
90-647
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33985509
Citation
Glowczynska R, Piotrowicz E, Szalewska D, Piotrowicz R, Kowalik I, Pencina MJ, Zareba W, Banach M, Orzechowski P, Pluta S, Irzmanski R, Kalarus Z, Opolski G. Effects of hybrid comprehensive telerehabilitation on cardiopulmonary capacity in heart failure patients depending on diabetes mellitus: subanalysis of the TELEREH-HF randomized clinical trial. Cardiovasc Diabetol. 2021 May 13;20(1):106. doi: 10.1186/s12933-021-01292-9.
Results Reference
derived
PubMed Identifier
31734701
Citation
Piotrowicz E, Pencina MJ, Opolski G, Zareba W, Banach M, Kowalik I, Orzechowski P, Szalewska D, Pluta S, Glowczynska R, Irzmanski R, Oreziak A, Kalarus Z, Lewicka E, Cacko A, Mierzynska A, Piotrowicz R. Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial. JAMA Cardiol. 2020 Mar 1;5(3):300-308. doi: 10.1001/jamacardio.2019.5006.
Results Reference
derived
PubMed Identifier
31654944
Citation
Piotrowicz E, Piotrowicz R, Opolski G, Pencina M, Banach M, Zareba W. Hybrid comprehensive telerehabilitation in heart failure patients (TELEREH-HF): A randomized, multicenter, prospective, open-label, parallel group controlled trial-Study design and description of the intervention. Am Heart J. 2019 Nov;217:148-158. doi: 10.1016/j.ahj.2019.08.015. Epub 2019 Aug 22.
Results Reference
derived

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

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