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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Use of telemedicine

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.

• Study Type: Observational
• Enrollment (Anticipated): 6480

Contacts and Locations

• Study Contact: Name: Jorna van Eijk, MSc; Phone Number: +31634609890; Email: j.vaneijk-4@umcutrecht.nl

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Recruiting
    • Noordwest ziekenhuisgroep
  • Amersfoort, Netherlands
    • Not yet recruiting
    • Meander Medisch Centrum
  • Amsterdam, Netherlands
    • Recruiting
    • OLVG
  • Apeldoorn, Netherlands
    • Not yet recruiting
    • Gelre Ziekenhuizen Apeldoorn
  • Assen, Netherlands
    • Not yet recruiting
    • Wilhelmina Ziekenhuis Assen
  • Boxmeer, Netherlands
    • Recruiting
    • Maasziekenhuis Pantein
  • Breda, Netherlands
    • Recruiting
    • Amphia Ziekenhuis
  • Delft, Netherlands
    • Not yet recruiting
    • Reinier de Graaf Gasthuis
  • Den Bosch, Netherlands
    • Not yet recruiting
    • Jeroen Bosch Ziekenhuis
  • Den Haag, Netherlands
    • Recruiting
    • Hagaziekenhuis
  • Den Haag, Netherlands
    • Not yet recruiting
    • Haaglanden Medisch Centrum
  • Deventer, Netherlands
    • Recruiting
    • Deventer Ziekenhuis
  • Doetinchem, Netherlands
    • Not yet recruiting
    • Slingeland Ziekenhuis
  • Ede, Netherlands
    • Not yet recruiting
    • Ziekenhuis Gelderse Vallei
  • Eindhoven, Netherlands
    • Recruiting
    • Catharina Ziekenhuis
  • Eindhoven, Netherlands
    • Recruiting
    • Máxima MC
  • Emmen, Netherlands
    • Recruiting
    • TREANT zorggroep
  • Enschede, Netherlands
    • Not yet recruiting
    • Medisch Spectrum Twente
  • Geldrop, Netherlands
    • Recruiting
    • Anna Ziekenhuis
  • Gouda, Netherlands
    • Not yet recruiting
    • Groene Hart Ziekenhuis
  • Groningen, Netherlands
    • Recruiting
    • Universitair Medisch Centrum Groningen
  • Helmond, Netherlands
    • Recruiting
    • Elkerliek Ziekenhuis
  • Hengelo, Netherlands
    • Not yet recruiting
    • Ziekenhuisgroep Twente
  • Leiden, Netherlands
    • Recruiting
    • Alrijne
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht UMC+
  • Nieuwegein, Netherlands
    • Not yet recruiting
    • St. Antonius Ziekenhuis
  • Nijmegen, Netherlands
    • Recruiting
    • RadoudUMC
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
  • Sittard, Netherlands
    • Not yet recruiting
    • Zuyderland Medisch Centrum
  • Tilburg, Netherlands
    • Recruiting
    • Elisabeth-Tweesteden Ziekenhuis
  • Uden, Netherlands
    • Not yet recruiting
    • Bernhoven
  • Utrecht, Netherlands
    • Not yet recruiting
    • Diakonessenhuis
  • Utrecht, Netherlands
    • Recruiting
    • UMC Utrecht
    • Contact: Jorna van Eijk, MSc
  • Venlo, Netherlands
    • Not yet recruiting
    • Viecuri Medisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Folkert W. Asselbergs, MD, PhD, UMC Utrecht

Publications and helpful links

Helpful Links

• Website to the Dutch Heart Registry

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Registry; Observational study; Multicenter
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 21-634/C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No