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Chronic Heart FailureTELEREH-HFNCT02523560

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

A study testing home-based telerehabilitation in people with Chronic Heart Failure, run by National Institute of Cardiology, Warsaw, Poland at 5 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
home-based telerehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
850 participants
Where
5 sitesPoland
Study dates
Jun 2015to Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 25Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Poland5 sites

  • Gdański Uniwersytet Medyczny

    Gdansk, 80-210

  • Klinika Chorób Wewnętrznych i Rehabilitacji Kardiologicznej

    Lodz, 90-647

  • Warsaw Medical University; Department of Cardiology

    Warsaw, 02-097

  • Institute of Cardiology

    Warsaw, 04-628

  • Slaskie Centrum Chorób Serca

    Zabrze, 41-800

Other trials in Poland

About this study

Official title: 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.

Read the 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
Being tested
home-based telerehabilitation
Keywords
Telerehabilitation, Home Monitoring, Heart Failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • home-based telerehabilitationOther

    Patients qualified to the study group will undergo, at five medical units a 9-week program of early hybrid, comprehensive cardiac telerehabilitation.

Study groups in NCT02523560
Study groupRoleWhat they receive
telerehabilitation groupExperimental1 week hospital rehabilitation and 8 weeks home-based telerehabilitation and telemanagement (including HomeMonitoring)
Receives: Other: home-based telerehabilitation
control groupNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. days alive and out of hospital

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
850 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02523560
Sponsor's protocol ID
STRATEGME1/233547/13/NCBR/2015
Acronym
TELEREH-HF
Status last verified
Mar 2018
First submitted
3 Aug 2015
Last updated
13 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Mierzynska A, Jaworska I, Piotrowicz R, Kowalik I, Pencina M, Opolski G, Zareba W, Banach M, Orzechowski P, Glowczynska R, Szalewska D, Pluta S, Kalarus Z, Irzmanski R, Piotrowicz E. The Influence of Hybrid Comprehensive Telerehabilitation on Anxiety in Heart Failure Patients: The TELEREH-HF Randomized Clinical Trial. J Clin Psychol Med Settings. 2024 Jun;31(2):403-416. doi: 10.1007/s10880-023-09985-x. Epub 2023 Dec 18.

    PubMed 38108961

  • Yang Z, Jia X, Li J, Mei Z, Yang L, Yan C, Han Y. Efficacy and Safety of Hybrid Comprehensive Telerehabilitation (HCTR) for Cardiac Rehabilitation in Patients with Cardiovascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Occup Ther Int. 2023 Aug 9;2023:5147805. doi: 10.1155/2023/5147805. eCollection 2023.

    PubMed 37593110

  • 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.

    PubMed 33985509

  • 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.

    PubMed 31734701

  • 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.

    PubMed 31654944

Questions about this trial

What is this clinical trial studying?

A study testing home-based telerehabilitation in people with Chronic Heart Failure, run by National Institute of Cardiology, Warsaw, Poland at 5 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

days alive and out of hospital (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02523560, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.

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