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

Heart Failure Clinical Trial

— RELEASE-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654961
• Other study ID #: 21-634/C
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: UMC Utrecht
• Contact: Jorna van Eijk, MSc
• Phone: +31634609890
• Email: j.vaneijk-4[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6480
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
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	Jeroen Bosch Ziekenhuis	Den Bosch
Netherlands	Haaglanden Medisch Centrum	Den Haag
Netherlands	HagaZiekenhuis	Den Haag
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	Elisabeth-TweeSteden Ziekenhuis	Tilburg
Netherlands	Bernhoven	Uden
Netherlands	Diakonessenhuis	Utrecht
Netherlands	UMC Utrecht	Utrecht
Netherlands	VieCuri Medisch Centrum	Venlo

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	All-cause mortality	Mortality status, determined after verification at the Personal Records Database (in Dutch: Basisregistratie Personen).	12 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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).	Baseline, 12 months
Secondary	Outpatient visits	Number of outpatient visits (planned/unplanned).	12 months
Secondary	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	12 months

External Links

•   Website to the Dutch Heart Registry