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

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ClinicalTrials.gov Identifier: NCT02523560
Recruitment Status : Completed
First Posted : August 14, 2015
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
National Center for Research and Development, Poland
Information provided by (Responsible Party):
Dr Ewa Piotrowicz, Institute of Cardiology, Warsaw, Poland

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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Other: home-based telerehabilitation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Applying Telemedicine Technologies in a Novel Model of Organizing and Implementing Comprehensive Cardiac Rehabilitation in Heart Failure Patients - TELEREH-HF
Actual Study Start Date : June 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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).



Primary Outcome Measures :
  1. days alive and out of hospital [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523560


Locations
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Poland
Gdański Uniwersytet Medyczny
Gdańsk, Poland, 80-210
Warsaw Medical University; Department of Cardiology
Warsaw, Poland, 02-097
Institute of Cardiology
Warsaw, Poland, 04-628
Slaskie Centrum Chorób Serca
Zabrze, Poland, 41-800
Klinika Chorób Wewnętrznych i Rehabilitacji Kardiologicznej
Łódź, Poland, 90-647
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
National Center for Research and Development, Poland
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Ewa Piotrowicz, MD, PhD, Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT02523560    
Other Study ID Numbers: STRATEGME1/233547/13/NCBR/2015
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Keywords provided by Dr Ewa Piotrowicz, Institute of Cardiology, Warsaw, Poland:
Telerehabilitation
Home Monitoring
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases