REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study
NCT ID: NCT05654961
Last Updated: 2022-12-16
Study Results
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Basic Information
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UNKNOWN
6480 participants
OBSERVATIONAL
2022-01-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Heart failure patients
According to the eligibility criteria specified below.
Use of telemedicine
Use of telemedicine (any type: telephone only, non-invasive, implantable-cardioverter-defibrillator-based, invasive) in heart failure management
Interventions
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Use of telemedicine
Use of telemedicine (any type: telephone only, non-invasive, implantable-cardioverter-defibrillator-based, invasive) in heart failure management
Eligibility Criteria
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Inclusion Criteria
* 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)
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Prof. Dr. F.W. Asselbergs
MD, PhD
Principal Investigators
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Folkert W. Asselbergs, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Meander Medisch Centrum
Amersfoort, , Netherlands
OLVG
Amsterdam, , Netherlands
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, , Netherlands
Wilhelmina Ziekenhuis Assen
Assen, , Netherlands
Maasziekenhuis Pantein
Boxmeer, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Slingeland Ziekenhuis
Doetinchem, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Máxima MC
Eindhoven, , Netherlands
Treant Zorggroep
Emmen, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Anna Ziekenhuis
Geldrop, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Elkerliek Ziekenhuis
Helmond, , Netherlands
Ziekenhuisgroep Twente
Hengelo, , Netherlands
Alrijne
Leiden, , Netherlands
Maastricht UMC+
Maastricht, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Radoudumc
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Zuyderland Medisch Centrum
Sittard, , Netherlands
Haaglanden Medisch Centrum
The Hague, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, , Netherlands
Bernhoven
Uden, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
VieCuri Medisch Centrum
Venlo, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Jorna van Eijk, MSc
Role: primary
References
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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.
Other Identifiers
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21-634/C
Identifier Type: -
Identifier Source: org_study_id
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