Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
Study NCT ID:
NCT04403659
Status:
UNKNOWN
Last Update Posted:
2020-05-27
First Post:
2020-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean daily number of physician visits', 'timeFrame': 'From allocation through to HaH discharge, in mean 15 days', 'description': 'Mean daily number of physician visits during Hospital at Home (HaH) stay, defined as total number of physician visits during HaH stay, divided by days of HaH stay, for every single patient'}], 'secondaryOutcomes': [{'measure': 'Mean daily number of nurse visits', 'timeFrame': 'From allocation through to HaH discharge, in mean 15 days', 'description': 'Mean daily number of nurse visits during Hospital at Home (HaH) stay, defined as total number of nurse visits during HaH stay, divided by days of HaH stay, for every single patient'}, {'measure': 'Mean daily number of urgent physician visits', 'timeFrame': 'From allocation through to HaH discharge, in mean 15 days', 'description': 'Mean daily number of urgent physician visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) physician visits during HaH stay, divided by days of HaH stay, for every single patient'}, {'measure': 'Mean daily number of urgent nurse visits', 'timeFrame': 'From allocation through to HaH discharge, in mean 15 days', 'description': 'Mean daily number of urgent nurse visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) nurse visits during HaH stay, divided by days of HaH stay, for every single patient'}, {'measure': 'Overall mortality', 'timeFrame': 'From allocation through to HaH discharge, in mean 15 days', 'description': 'Death by any cause during Hospital at Home (HaH) stay'}, {'measure': "Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12)", 'timeFrame': 'At HaH discharge, in mean 15 days after allocation', 'description': "Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge"}, {'measure': "Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12)", 'timeFrame': "At patient's HaH discharge, in mean 15 days after allocation", 'description': "Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Telemonitoring', 'Hospital at Home', 'Home Hospitalization'], 'conditions': ['Heart Failure; With Decompensation', 'Heart Failure，Congestive', 'Heart Failure Acute']}, 'referencesModule': {'references': [{'pmid': '19786675', 'type': 'BACKGROUND', 'citation': 'Tibaldi V, Isaia G, Scarafiotti C, Gariglio F, Zanocchi M, Bo M, Bergerone S, Ricauda NA. Hospital at home for elderly patients with acute decompensation of chronic heart failure: a prospective randomized controlled trial. Arch Intern Med. 2009 Sep 28;169(17):1569-75. doi: 10.1001/archinternmed.2009.267.'}, {'pmid': '27206819', 'type': 'BACKGROUND', 'citation': 'Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.'}, {'pmid': '8628042', 'type': 'BACKGROUND', 'citation': 'Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.'}]}, 'descriptionModule': {'briefSummary': '"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. In this context, MONTEROSA is a monocentric randomized controlled open-label clinical trial evaluating the use of a telemonitoring/telemedicine (TM) suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care of patients admitted to a Hospital at Home service for acute decompensated heart failure.\n\nThe main objective of the study will be to evaluate the impact of TM on number of daily physician\'s visits. Secondary objectives will be to evaluate the impact of TM on number of daily nurse visits, on overall in-hospital mortality and on patient\'s and caregiver\'s quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient admitted in Hospital at Home with signs and/or symptoms of new-onset or decompensated heart failure, according with the definition of 2016 European Society of Cardiology (ESC) guidelines on Heart Failure\n* Written informed consent signed by both the patient and the main caregiver\n\nExclusion Criteria:\n\n* Main caregiver with low IT skills (e.g. unable to use a smartphone);\n* Patient in whom body weight or accurate daily urine output cannot be measured\n* Patient with history of neoplastic/degenerative disease and with estimated life expectancy less than 3 months\n* Patient with decompensated liver cirrhosis (Child-Pugh score B o C)'}, 'identificationModule': {'nctId': 'NCT04403659', 'acronym': 'MONTEROSA', 'briefTitle': 'Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Monitoraggio Telematico di Pazienti Ricoverati in Ospedalizzazione a Domicilio Per Scompenso Cardiaco Acuto - Studio Pilota', 'orgStudyIdInfo': {'id': 'MONTEROSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Use of a telemonitoring/telemedicine suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care', 'interventionNames': ['Device: Telemedicine/telemonitoring (TM) suite']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine clinical care, following European Society of Cardiology 2016 Guidelines on Heart failure and Good Clinical Practice guidelines'}], 'interventions': [{'name': 'Telemedicine/telemonitoring (TM) suite', 'type': 'DEVICE', 'description': 'The couples patient/caregiver will receive and trained to use a suite of TM instruments including: sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph. During the intervention phase (i.e. from allocation to exit from the study), the caregiver/patient will be asked to measure twice daily, at prespecified times, the following parameters using TM devices: arterial blood pressure, peripheral arterial haemoglobin saturation, tympanic temperature. Body weight will be evaluated once daily.\n\nThe TM glucometer and TM electrocardiograph will be used exclusively by healthcare staff in case of patients in need of capillary blood glucose testing and according to clinical needs, respectively. All data will be automatically sent to a central interface and made readily available to physicians and nurses, to enable a prompt clinical response. In case of malfunctioning, a technical support will be ensured.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'state': 'TO', 'country': 'Italy', 'facility': "S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino", 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'centralContacts': [{'name': 'Renata Marinello, MD, PhD', 'role': 'CONTACT', 'email': 'rmarinello@cittadellasalute.to.it', 'phone': '0116334771', 'phoneExt': '+39'}], 'overallOfficials': [{'name': 'Renata Marinello, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OAU Città della Salute e della Scienza di Torino, Turin, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'collaborators': [{'name': 'Santer Reply S.p.A. Milan, Italy', 'class': 'UNKNOWN'}, {'name': 'Caretek S.r.l. Turin, Italy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dott.ssa RENATA MARINELLO', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}