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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.
The objectives of the study are to examine:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart failure patients | According to the eligibility criteria specified below. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of telemedicine | Other | Use of telemedicine (any type: telephone only, non-invasive, implantable-cardioverter-defibrillator-based, invasive) in heart failure management |
|
| 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 |
| 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 |
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Inclusion Criteria:
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Patients diagnosed with heart failure and who are treated at an outpatient clinic in the Netherlands, with or without telemedicine use.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorna van Eijk, MSc | Contact | +31634609890 | j.vaneijk-4@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Folkert W. Asselbergs, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch Ziekenhuis | Not yet recruiting | 's-Hertogenbosch | Netherlands | |||
| Noordwest Ziekenhuisgroep |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38176879 | Derived | 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. |
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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 |
| Recruiting |
| Alkmaar |
| Netherlands |
| Meander Medisch Centrum | Not yet recruiting | Amersfoort | Netherlands |
| OLVG | Recruiting | Amsterdam | Netherlands |
| Gelre Ziekenhuizen Apeldoorn | Not yet recruiting | Apeldoorn | Netherlands |
| Wilhelmina Ziekenhuis Assen | Not yet recruiting | Assen | Netherlands |
| Maasziekenhuis Pantein | Recruiting | Boxmeer | Netherlands |
| Amphia Ziekenhuis | Recruiting | Breda | Netherlands |
| Reinier de Graaf Gasthuis | Not yet recruiting | Delft | Netherlands |
| Deventer Ziekenhuis | Recruiting | Deventer | Netherlands |
| Slingeland Ziekenhuis | Not yet recruiting | Doetinchem | Netherlands |
| Ziekenhuis Gelderse Vallei | Not yet recruiting | Ede | Netherlands |
| Catharina Ziekenhuis | Recruiting | Eindhoven | Netherlands |
| Máxima MC | Recruiting | Eindhoven | Netherlands |
| Treant Zorggroep | Recruiting | Emmen | Netherlands |
| Medisch Spectrum Twente | Not yet recruiting | Enschede | Netherlands |
| Anna Ziekenhuis | Recruiting | Geldrop | Netherlands |
| Groene Hart Ziekenhuis | Not yet recruiting | Gouda | Netherlands |
| Universitair Medisch Centrum Groningen | Recruiting | Groningen | Netherlands |
| Elkerliek Ziekenhuis | Recruiting | Helmond | Netherlands |
| Ziekenhuisgroep Twente | Not yet recruiting | Hengelo | Netherlands |
| Alrijne | Recruiting | Leiden | Netherlands |
| Maastricht UMC+ | Recruiting | Maastricht | Netherlands |
| St. Antonius Ziekenhuis | Not yet recruiting | Nieuwegein | Netherlands |
| Radoudumc | Recruiting | Nijmegen | Netherlands |
| Erasmus MC | Recruiting | Rotterdam | Netherlands |
| Zuyderland Medisch Centrum | Not yet recruiting | Sittard | Netherlands |
| Haaglanden Medisch Centrum | Not yet recruiting | The Hague | Netherlands |
| HagaZiekenhuis | Recruiting | The Hague | Netherlands |
| Elisabeth-TweeSteden Ziekenhuis | Recruiting | Tilburg | Netherlands |
| Bernhoven | Not yet recruiting | Uden | Netherlands |
| Diakonessenhuis | Not yet recruiting | Utrecht | Netherlands |
| UMC Utrecht | Recruiting | Utrecht | Netherlands |
|
| VieCuri Medisch Centrum | Not yet recruiting | Venlo | Netherlands |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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