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

Last updated: December 14, 2022
Sponsor: UMC Utrecht
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT05654961
21-634/C
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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)

Study Design

Total Participants: 6480
Study Start date:
January 01, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Noordwest Ziekenhuisgroep

    Alkmaar,
    Netherlands

    Active - Recruiting

  • Meander Medisch Centrum

    Amersfoort,
    Netherlands

    Site Not Available

  • OLVG

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn,
    Netherlands

    Site Not Available

  • Wilhelmina Ziekenhuis Assen

    Assen,
    Netherlands

    Site Not Available

  • Maasziekenhuis Pantein

    Boxmeer,
    Netherlands

    Active - Recruiting

  • Amphia Ziekenhuis

    Breda,
    Netherlands

    Active - Recruiting

  • Reinier de Graaf Gasthuis

    Delft,
    Netherlands

    Site Not Available

  • Jeroen Bosch Ziekenhuis

    Den Bosch,
    Netherlands

    Site Not Available

  • Haaglanden Medisch Centrum

    Den Haag,
    Netherlands

    Site Not Available

  • HagaZiekenhuis

    Den Haag,
    Netherlands

    Active - Recruiting

  • Deventer Ziekenhuis

    Deventer,
    Netherlands

    Active - Recruiting

  • Slingeland Ziekenhuis

    Doetinchem,
    Netherlands

    Site Not Available

  • Ziekenhuis Gelderse Vallei

    Ede,
    Netherlands

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Máxima MC

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Treant Zorggroep

    Emmen,
    Netherlands

    Active - Recruiting

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Site Not Available

  • Anna Ziekenhuis

    Geldrop,
    Netherlands

    Active - Recruiting

  • Groene Hart Ziekenhuis

    Gouda,
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Elkerliek Ziekenhuis

    Helmond,
    Netherlands

    Active - Recruiting

  • Ziekenhuisgroep Twente

    Hengelo,
    Netherlands

    Site Not Available

  • Alrijne

    Leiden,
    Netherlands

    Active - Recruiting

  • Maastricht UMC+

    Maastricht,
    Netherlands

    Active - Recruiting

  • St. Antonius Ziekenhuis

    Nieuwegein,
    Netherlands

    Site Not Available

  • Radoudumc

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Zuyderland Medisch Centrum

    Sittard,
    Netherlands

    Site Not Available

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg,
    Netherlands

    Active - Recruiting

  • Bernhoven

    Uden,
    Netherlands

    Site Not Available

  • Diakonessenhuis

    Utrecht,
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht,
    Netherlands

    Active - Recruiting

  • VieCuri Medisch Centrum

    Venlo,
    Netherlands

    Site Not Available

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