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

Sponsor

UMC Utrecht (Other)

Overall Status

Recruiting

CT.gov ID

NCT05654961

Collaborator

(none)

6,480

Enrollment

Locations

Anticipated Duration (Months)

190.6

Patients Per Site

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Use of telemedicine

Detailed Description

The objectives of the study are to examine:

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?
which HF patient characteristics are related to cost-effectiveness when telemedicine is part of regular care compared to regular HF care alone?
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?
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:

National Heart Failure Registry (abbreviated as Registry; a patient registry),
Interviews with clinicians about telemedicine features on hospital level,
Interviews with finance department staff about costs in HF care (including telemedicine use),
Electronic Health Record (EHR) data about telemedicine (including supplier system data)
External national registries and/or databases as Statistics Netherlands (CBS), declaration data (Vektis), Dutch Hospital Data (DHD) or PHARMO.

Study Design

Study Type:

Observational

Anticipated Enrollment :

6480 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Heart failure patients According to the eligibility criteria specified below.	Other: Use of telemedicine Use of telemedicine (any type: telephone only, non-invasive, implantable-cardioverter-defibrillator-based, invasive) in heart failure management

Arm

Intervention/Treatment

Heart failure patients

According to the eligibility criteria specified below.

Other: Use of telemedicine

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

Outcome Measures

Primary Outcome Measures

Number of days spent outside the hospital within one year of follow-up [12 months]
The number of days will be derived from the number of hospital days and mortality status between follow-up moments.

Secondary Outcome Measures

All-cause mortality [12 months]
Mortality status, determined after verification at the Personal Records Database (in Dutch: Basisregistratie Personen).
Change from baseline in functional status at 12 months [Baseline, 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.
Change from baseline in health status at 12 months [Baseline, 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.
Change from baseline in QoL (Quality of Life) at 12 months [Baseline, 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).
Outpatient visits [12 months]
Number of outpatient visits (planned/unplanned).
Costs [12 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country
1	Noordwest Ziekenhuisgroep	Alkmaar	Netherlands
2	Meander Medisch Centrum	Amersfoort	Netherlands
3	OLVG	Amsterdam	Netherlands
4	Gelre Ziekenhuizen Apeldoorn	Apeldoorn	Netherlands
5	Wilhelmina Ziekenhuis Assen	Assen	Netherlands
6	Maasziekenhuis Pantein	Boxmeer	Netherlands
7	Amphia Ziekenhuis	Breda	Netherlands
8	Reinier de Graaf Gasthuis	Delft	Netherlands
9	Jeroen Bosch Ziekenhuis	Den Bosch	Netherlands
10	Haaglanden Medisch Centrum	Den Haag	Netherlands
11	HagaZiekenhuis	Den Haag	Netherlands
12	Deventer Ziekenhuis	Deventer	Netherlands
13	Slingeland Ziekenhuis	Doetinchem	Netherlands
14	Ziekenhuis Gelderse Vallei	Ede	Netherlands
15	Catharina Ziekenhuis	Eindhoven	Netherlands
16	Máxima MC	Eindhoven	Netherlands
17	Treant Zorggroep	Emmen	Netherlands
18	Medisch Spectrum Twente	Enschede	Netherlands
19	Anna Ziekenhuis	Geldrop	Netherlands
20	Groene Hart Ziekenhuis	Gouda	Netherlands
21	Universitair Medisch Centrum Groningen	Groningen	Netherlands
22	Elkerliek Ziekenhuis	Helmond	Netherlands
23	Ziekenhuisgroep Twente	Hengelo	Netherlands
24	Alrijne	Leiden	Netherlands
25	Maastricht UMC+	Maastricht	Netherlands
26	St. Antonius Ziekenhuis	Nieuwegein	Netherlands
27	Radoudumc	Nijmegen	Netherlands
28	Erasmus MC	Rotterdam	Netherlands
29	Zuyderland Medisch Centrum	Sittard	Netherlands
30	Elisabeth-TweeSteden Ziekenhuis	Tilburg	Netherlands
31	Bernhoven	Uden	Netherlands
32	Diakonessenhuis	Utrecht	Netherlands
33	UMC Utrecht	Utrecht	Netherlands
34	VieCuri Medisch Centrum	Venlo	Netherlands