Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06077851
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2023-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Monitoring of Vital Signs at Home (WARD HOME II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075902', 'term': 'Clinical Deterioration'}], 'ancestors': [{'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frequency of automatically generated alerts on deviating vital signs', 'timeFrame': '72 hours', 'description': 'per device per patient per day'}, {'measure': 'Number of automatically generated alerts', 'timeFrame': '72 hours', 'description': 'From all devices worn, per patient per day'}, {'measure': 'Frequency of alerts which are responded to by healthcare personnel', 'timeFrame': '72 hours', 'description': 'Number of alerts triggered by deviating vital signs, per patient per day'}, {'measure': "Fraction of time within the study period with at least one type of data transmitted in real time from patients' homes.", 'timeFrame': '72 hours'}], 'primaryOutcomes': [{'measure': '(Re)admission', 'timeFrame': 'within 30 days', 'description': 'Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact'}, {'measure': 'Serious Adverse Events', 'timeFrame': 'within 30 days', 'description': "Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE)."}, {'measure': 'Mortality', 'timeFrame': 'within 30 days'}], 'secondaryOutcomes': [{'measure': '(Re)admission', 'timeFrame': 'within 7 days after discharge/assessment by paramedic personnel', 'description': 'Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact'}, {'measure': 'Inquiries to the Emergency Medical Service', 'timeFrame': 'within 30 days', 'description': 'Defined as patients calls to 1813/112'}, {'measure': 'Mortality and types of SAEs', 'timeFrame': 'within 30 days', 'description': "Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vital Sign Monitoring', 'Clinical Deterioration', 'Hospital At Home']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the use of wireless, continuous monitoring in patients at home including the frequency of alarms triggered by abnormal vital parameters and their significance for (re)hospitalisation/Serious Adverse Events(SAE) and/or death within 30 days.', 'detailedDescription': "Acute hospital admissions challenge the capacity of the healthcare system. Readmission is common among patients with chronic medical diseases, and many patients admitted for acute conditions are often subsequently observed at the hospital for hours and often with one overnight stay for observation purposes alone. Recent medico technical research has allowed continuous and wireless monitoring of patients' vital signs in-hospital, but the practice at home remains uninvestigated. However, the technology has the potential to relieve hospital overcrowding by offering continuous and real time analytics of vital signs in high-risk patients at home."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted with an acute medical disease at Bispebjerg Hospital or Rigshospitalet, or assessed by paramedic personnel at home after contact to the EMS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients (≥18 years) admitted (with at least one night stay) with an acute medical disease and scheduled for discharge to their own homes\n\nAdult patients (≥18 years) who have contacted the EMS and, after assessment by paramedic personnel, not deemed sick enough for immediate hospital admission.\n\nExclusion Criteria:\n\nPatients placed on palliative treatment.\n\nAcceptable chronically abnormal vital parameters of SpO2\\<88%, MAP\\<70, RR\\>24, or HR\\>110.\n\nAllergy to plaster, plastic, or silicone.\n\nA pacemaker or Implantable Cardioverter Defibrillator (ICD) device.\n\nIf the patient was deemed not able to open the front door when visited by the investigator.\n\nInability to give informed consent.'}, 'identificationModule': {'nctId': 'NCT06077851', 'briefTitle': 'Continuous Monitoring of Vital Signs at Home (WARD HOME II)', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Continuous Monitoring With Real-time Transmission of Vital Signs to Healthcare Professionals From Patients at Home', 'orgStudyIdInfo': {'id': '2308603'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Continuously monitoring', 'type': 'DEVICE', 'description': 'Included patients are monitored with WARD equipment the first days after discharge. Monitoring will last for a maximum of three days.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'NV', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Emilie Sigvardt, MD', 'role': 'CONTACT', 'email': 'emilie.sigvardt@regionh.dk', 'phone': '+4528254123'}], 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Emilie Sigvardt, MD', 'role': 'CONTACT', 'email': 'emilie.sigvardt@regionh.dk', 'phone': '28254123'}, {'name': 'Christian Sylvest Meyhoff, MD, PhD', 'role': 'CONTACT', 'email': 'christian.sylvest.meyhoff@regionh.dk', 'phone': '+4524910542'}], 'overallOfficials': [{'name': 'Emilie Sigvardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Technical University of Denmark', 'class': 'OTHER'}, {'name': 'Emergency Medical Services, Capital Region, Denmark', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Emilie Sigvardt', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}