Clinical trial NCT05654961: REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study
Official title: REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: Telemedicine
Observational study
Registry
Multicenter
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 6480
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with heart failure and who are treated at an outpatient clinic in the Netherlands, with or without telemedicine use.

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of days spent outside the hospital within one year of follow-up
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 12 months
measure: Change from baseline in functional status at 12 months
timeFrame: Baseline, 12 months
measure: Change from baseline in health status at 12 months
timeFrame: Baseline, 12 months
measure: Change from baseline in QoL (Quality of Life) at 12 months
timeFrame: Baseline, 12 months
measure: Outpatient visits
timeFrame: 12 months
measure: Costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: OLVG
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen Apeldoorn
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis Assen
city: Boxmeer
country: Netherlands
facility: Maasziekenhuis Pantein
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Máxima MC
city: Emmen
country: Netherlands
facility: Treant Zorggroep
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Geldrop
country: Netherlands
facility: Anna Ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Leiden
country: Netherlands
facility: Alrijne
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radoudumc
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Sittard
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
city: Uden
country: Netherlands
facility: Bernhoven
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
Study officials:
affiliation: UMC Utrecht
name: Folkert W. Asselbergs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: