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Heart FailureRELEASE-HFNCT05654961

REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study

An observational study of Heart Failure, run by UMC Utrecht at 34 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Telemedicine is gradually becoming accepted in heart failure (HF) management. Meta-analyses show a positive effect of telemedicine on hospital admission, length of stay, mortality, and costs. Read more about this study

Who is it for?
Any age
Conditions the study is for
Heart Failure
What is being tested?
Use of telemedicine
How many people
6,480 participants
Where
34 sitesNetherlands
Study dates
1 Jan 2022to 31 Dec 2024
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients diagnosed with heart failure and who are treated at an outpatient clinic in the Netherlands, with or without telemedicine use.

Who may be able to join

  • All heart failure patients newly admitted to a hospital outpatient clinic for HF
  • All phenotypes of heart failure that meet the ESC 2021 guideline
  • Patient who has been diagnosed with heart failure in a setting other than the one where the patient currently presents (primary, secondary or tertiary care)

Who cannot join

None listed.

Trial locations and contacts

34 sites in 1 country.

Jorna van Eijk, MSc contact

+31634609890

j.vaneijk-4@umcutrecht.nl

34 sites in 1 country

Netherlands34 sites, 34 recruiting

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

    Not yet recruiting

  • Noordwest Ziekenhuisgroep

    Alkmaar

    Recruiting

  • Meander Medisch Centrum

    Amersfoort

    Not yet recruiting

  • OLVG

    Amsterdam

    Recruiting

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn

    Not yet recruiting

  • Wilhelmina Ziekenhuis Assen

    Assen

    Not yet recruiting

  • Maasziekenhuis Pantein

    Boxmeer

    Recruiting

  • Amphia Ziekenhuis

    Breda

    Recruiting

  • Reinier de Graaf Gasthuis

    Delft

    Not yet recruiting

  • Deventer Ziekenhuis

    Deventer

    Recruiting

  • Slingeland Ziekenhuis

    Doetinchem

    Not yet recruiting

  • Ziekenhuis Gelderse Vallei

    Ede

    Not yet recruiting

  • Catharina Ziekenhuis

    Eindhoven

    Recruiting

  • Máxima MC

    Eindhoven

    Recruiting

  • Treant Zorggroep

    Emmen

    Recruiting

  • Medisch Spectrum Twente

    Enschede

    Not yet recruiting

  • Anna Ziekenhuis

    Geldrop

    Recruiting

  • Groene Hart Ziekenhuis

    Gouda

    Not yet recruiting

  • Universitair Medisch Centrum Groningen

    Groningen

    Recruiting

  • Elkerliek Ziekenhuis

    Helmond

    Recruiting

  • Ziekenhuisgroep Twente

    Hengelo

    Not yet recruiting

  • Alrijne

    Leiden

    Recruiting

  • Maastricht UMC+

    Maastricht

    Recruiting

  • St. Antonius Ziekenhuis

    Nieuwegein

    Not yet recruiting

  • Radoudumc

    Nijmegen

    Recruiting

  • Erasmus MC

    Rotterdam

    Recruiting

  • Zuyderland Medisch Centrum

    Sittard

    Not yet recruiting

  • Haaglanden Medisch Centrum

    The Hague

    Not yet recruiting

  • HagaZiekenhuis

    The Hague

    Recruiting

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg

    Recruiting

  • Bernhoven

    Uden

    Not yet recruiting

  • Diakonessenhuis

    Utrecht

    Not yet recruiting

  • UMC Utrecht

    Utrecht

    Jorna van Eijk, MSc

    Recruiting

  • VieCuri Medisch Centrum

    Venlo

    Not yet recruiting

Other trials in Netherlands

About this study

Telemedicine is gradually becoming accepted in heart failure (HF) management. Meta-analyses show a positive effect of telemedicine on hospital admission, length of stay, mortality, and costs. However, the magnitude of the effect is heterogeneous because of the variety in the HF population using telemedicine, components of telemedicine, and variety in considered costs. Despite the lack of clear guidance how to implement telemedicine within routine HF management, implementation of telemedicine is advocated by payers, private companies, and patient organizations.

In this nationwide study the investigators aim to identify in which subgroup of HF patients telemedicine is (cost-)effective, and which intervention components of telemedicine are most (cost-)effective.

Read the detailed description

The objectives of the study are to examine:

  1. which HF patient characteristics are related to an increase in number of days spent outside the hospital within one year of follow-up, when telemedicine is part of regular HF care compared to regular HF care alone?
  2. which HF patient characteristics are related to cost-effectiveness when telemedicine is part of regular care compared to regular HF care alone?
  3. which components of telemedicine as part of regular HF care lead to an increase in number of days spent outside the hospital within one year of follow-up?
  4. which components of telemedicine as part of regular HF care are cost-effective?

The main focus of this study is on patient-related subgroup analyses with telemedicine. The patient-related subgroups are identified by a systematic literature review of randomized-controlled trials of telemedicine: (1) age, (2) severity of HF (NYHA class at baseline), (3) sex (female compared to male), (4) socio-economic status (SES) (HF patients with higher SES compared to lower SES), (5) presence of depression, (6) Type of heart failure (LVEF: HFrEF, HFmrEF, HFpEF), (7) presence of atrial fibrillation (AF). In an additional analysis, (8) heterogeneity across time of diagnosis will be explored (recently diagnosed compared to not recently diagnosed).

To answer the four research questions a RELEASE-HF database will be set up. The RELEASE-HF database will be composed from various data sources:

  1. National Heart Failure Registry (abbreviated as Registry; a patient registry),
  2. Interviews with clinicians about telemedicine features on hospital level,
  3. Interviews with finance department staff about costs in HF care (including telemedicine use),
  4. Electronic Health Record (EHR) data about telemedicine (including supplier system data)
  5. External national registries and/or databases as Statistics Netherlands (CBS), declaration data (Vektis), Dutch Hospital Data (DHD) or PHARMO.
Conditions
Heart Failure
Being tested
Use of telemedicine
Keywords
Telemedicine, Observational study, Registry, Multicenter
Medical subject headings
Heart Failure

What participants receive

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

  • Use of telemedicineOther

    Use of telemedicine (any type: telephone only, non-invasive, implantable-cardioverter-defibrillator-based, invasive) in heart failure management

Study groups in NCT05654961
Study groupRoleWhat they receive
Heart failure patientsAccording to the eligibility criteria specified below.
Receives: Other: Use of telemedicine

What is being measured

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

  1. Number of days spent outside the hospital within one year of follow-up

    The number of days will be derived from the number of hospital days and mortality status between follow-up moments.

    Measured: 12 months

Secondary outcomes (6)

  1. All-cause mortality

    Mortality status, determined after verification at the Personal Records Database (in Dutch: Basisregistratie Personen).

    Measured: 12 months

  2. Change from baseline in functional status at 12 months

    New York Heart Association classification class (NYHA): a functional classification of patients, based on severity of symptoms and physical activity, with specific attention to fatigue, palpitation, and dyspnea. NYHA exist of four classifacation. A higher class means a patient has more physcial problems caused by heart failure.

    Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

    Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

    Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

    Measured: Baseline, 12 months

  3. Change from baseline in health status at 12 months

    SF-36 or SF-12 questionnaire (subset of SF-36): a validated patient-reported survey of patient health. Both questionnaires consist of eight sections with scores: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each score is transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the lower the health status.

    Measured: Baseline, 12 months

  4. Change from baseline in QoL (Quality of Life) at 12 months

    SF-36 or SF-12 questionnaire. Quality Adjusted Life Years (QALY) will be calculated based on the SF-6D: a model in which directly a single, preference-based score can be calculated for the SF-36 and SF-12. Scores range from 0.0 (worst health state) to 1.0 (best health state).

    Measured: Baseline, 12 months

  5. Outpatient visits

    Number of outpatient visits (planned/unplanned).

    Measured: 12 months

  6. Costs

    Costs estimated from patient, disease, and treatment characteristics. Information taken into account includes medication use, whether the patient underwent cardiac interventions (e.g., pacemaker implantation, percutaneous coronary intervention), use of telemedicine, hospital admission days, visits to the outpatient clinic, visits to the emergency room, admission days at an intensive care unit, visits at the GP related to HF

    Measured: 12 months

Timeline

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

  1. First posted16 Dec 2022
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654961
Sponsor's protocol ID
21-634/C
Acronym
RELEASE-HF
Status last verified
Dec 2022
First submitted
1 Dec 2022
Last updated
16 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van Eijk J, Luijken K, Jaarsma T, Reitsma JB, Schuit E, Frederix GWJ, Derks L, Schaap J, Rutten FH, Brugts J, de Boer RA, Asselbergs FW, Trappenburg JCA; RELEASE-HF Investigators. RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands. BMJ Open. 2024 Jan 4;14(1):e078021. doi: 10.1136/bmjopen-2023-078021.

    PubMed 38176879

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by UMC Utrecht at 34 sites in Netherlands.

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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Netherlands. 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?

Results are not available in the source record.

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

Contact Jorna van Eijk, MSc (+31634609890, j.vaneijk-4@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of days spent outside the hospital within one year of follow-up (time frame: 12 months). 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 NCT05654961, which also lists 1 linked publication.

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 16 Dec 2022.

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