Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-30 @ 6:49 PM
Study NCT ID:
NCT05654961
Status:
UNKNOWN
Last Update Posted:
2022-12-16
First Post:
2022-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-14', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days spent outside the hospital within one year of follow-up', 'timeFrame': '12 months', 'description': 'The number of days will be derived from the number of hospital days and mortality status between follow-up moments.'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '12 months', 'description': 'Mortality status, determined after verification at the Personal Records Database (in Dutch: Basisregistratie Personen).'}, {'measure': 'Change from baseline in functional status at 12 months', 'timeFrame': 'Baseline, 12 months', 'description': '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.\n\nClass I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).\n\nClass II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).\n\nClass III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.\n\nClass IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.'}, {'measure': 'Change from baseline in health status at 12 months', 'timeFrame': 'Baseline, 12 months', 'description': '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.'}, {'measure': 'Change from baseline in QoL (Quality of Life) at 12 months', 'timeFrame': 'Baseline, 12 months', 'description': '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).'}, {'measure': 'Outpatient visits', 'timeFrame': '12 months', 'description': 'Number of outpatient visits (planned/unplanned).'}, {'measure': 'Costs', 'timeFrame': '12 months', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Observational study', 'Registry', 'Multicenter'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '38176879', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.', 'detailedDescription': 'The objectives of the study are to examine:\n\n1. 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?\n2. which HF patient characteristics are related to cost-effectiveness when telemedicine is part of regular care compared to regular HF care alone?\n3. 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?\n4. which components of telemedicine as part of regular HF care are cost-effective?\n\nThe 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).\n\nTo answer the four research questions a RELEASE-HF database will be set up. The RELEASE-HF database will be composed from various data sources:\n\n1. National Heart Failure Registry (abbreviated as Registry; a patient registry),\n2. Interviews with clinicians about telemedicine features on hospital level,\n3. Interviews with finance department staff about costs in HF care (including telemedicine use),\n4. Electronic Health Record (EHR) data about telemedicine (including supplier system data)\n5. External national registries and/or databases as Statistics Netherlands (CBS), declaration data (Vektis), Dutch Hospital Data (DHD) or PHARMO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with heart failure and who are treated at an outpatient clinic in the Netherlands, with or without telemedicine use.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All heart failure patients newly admitted to a hospital outpatient clinic for HF\n* All phenotypes of heart failure that meet the ESC 2021 guideline\n* 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)'}, 'identificationModule': {'nctId': 'NCT05654961', 'acronym': 'RELEASE-HF', 'briefTitle': 'REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'REsponsible roLl-out of E-heAlth Through Systematic Evaluation - Heart Failure Study', 'orgStudyIdInfo': {'id': '21-634/C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart failure patients', 'description': 'According to the eligibility criteria specified below.', 'interventionNames': ['Other: Use of telemedicine']}], 'interventions': [{'name': 'Use of telemedicine', 'type': 'OTHER', 'description': 'Use of telemedicine (any type: telephone only, non-invasive, implantable-cardioverter-defibrillator-based, invasive) in heart failure management', 'armGroupLabels': ['Heart failure patients']}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Hertogenbosch", 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Alkmaar', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Noordwest Ziekenhuisgroep', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Amersfoort', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Meander Medisch Centrum', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Apeldoorn', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuizen Apeldoorn', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'city': 'Assen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Wilhelmina Ziekenhuis Assen', 'geoPoint': {'lat': 52.99667, 'lon': 6.5625}}, {'city': 'Boxmeer', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Maasziekenhuis Pantein', 'geoPoint': {'lat': 51.64667, 'lon': 5.94722}}, {'city': 'Breda', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Delft', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Reinier de Graaf Gasthuis', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'city': 'Deventer', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Deventer Ziekenhuis', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'city': 'Doetinchem', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Slingeland Ziekenhuis', 'geoPoint': {'lat': 51.965, 'lon': 6.28889}}, {'city': 'Ede', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Ziekenhuis Gelderse Vallei', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Máxima MC', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Emmen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Treant Zorggroep', 'geoPoint': {'lat': 52.77917, 'lon': 6.90694}}, {'city': 'Enschede', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Geldrop', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Anna Ziekenhuis', 'geoPoint': {'lat': 51.42167, 'lon': 5.55972}}, {'city': 'Gouda', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Groene Hart Ziekenhuis', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Helmond', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Elkerliek Ziekenhuis', 'geoPoint': {'lat': 51.48167, 'lon': 5.66111}}, {'city': 'Hengelo', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Ziekenhuisgroep Twente', 'geoPoint': {'lat': 52.26583, 'lon': 6.79306}}, {'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Alrijne', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Maastricht UMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nieuwegein', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Radoudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Sittard', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Zuyderland Medisch Centrum', 'geoPoint': {'lat': 50.99833, 'lon': 5.86944}}, {'city': 'The Hague', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Haaglanden Medisch Centrum', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Tilburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Elisabeth-TweeSteden Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Uden', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Bernhoven', 'geoPoint': {'lat': 51.66083, 'lon': 5.61944}}, {'city': 'Utrecht', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Diakonessenhuis', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jorna van Eijk, MSc', 'role': 'CONTACT'}], 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Venlo', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'VieCuri Medisch Centrum', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}], 'centralContacts': [{'name': 'Jorna van Eijk, MSc', 'role': 'CONTACT', 'email': 'j.vaneijk-4@umcutrecht.nl', 'phone': '+31634609890'}], 'overallOfficials': [{'name': 'Folkert W. Asselbergs, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Prof. Dr. F.W. Asselbergs', 'investigatorAffiliation': 'UMC Utrecht'}}}}