Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 5:11 PM
Study NCT ID:
NCT05223504
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WARD-Home - Continuous Monitoring of Vital Parameters After Discharge
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': 'ACTUAL', 'count': 80}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Re-admission and cause of re-admission within 30-days', 'timeFrame': '30-days follow up'}], 'primaryOutcomes': [{'measure': 'Duration of data collection from the Lifetouch patch', 'timeFrame': 'Up to 8 days of monitoring'}], 'secondaryOutcomes': [{'measure': 'Duration of complete peripheral saturation data', 'timeFrame': 'Up to 8 days of monitoring'}, {'measure': 'Duration of complete blood pressure data', 'timeFrame': 'Up to 8 days of monitoring'}, {'measure': 'Cummulated duration of desaturation', 'timeFrame': 'Up to 8 days of monitoring', 'description': 'Peripheral saturation below 88% and 85%'}, {'measure': 'Number of events with SpO2 < 88% in at least 10 consecutive minutes', 'timeFrame': 'Up to 8 days of monitoring'}, {'measure': 'Number of events with SpO2 < 85% in at least 5 consecutive minutes', 'timeFrame': 'Up to 8 days of monitoring'}, {'measure': 'Number of deviating vital parameters in accordance to defined microevents', 'timeFrame': 'Up to 8 days of monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vital Sign', 'Clinical Deterioration']}, 'descriptionModule': {'briefSummary': 'The current pilot study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs in this patient group.', 'detailedDescription': "The healthcare system is challenged by an aging patient population with chronic diseases, and acute admissions must be housed in hospitals with fewer beds and less staff resources. This increases the need for earlier discharge and for treatment shifted to the patients' own home. Furthermore, the transition from the hospital to the home setting is one of potential hazard, due to the lack of observation and intervention possibilities.\n\nThis pilot study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs i in the patients' own homes during the first days after discharge."}, '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 and scheduled for discharge to their own homes within five days from inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients (≥18 years) Admitted with an acute medical disease and scheduled for discharge to their own homes within five days from inclusion.\n\nExclusion Criteria:\n\n* Allergy to plaster, plastic, or silicone.\n* A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.\n* If the patient was deemed not able to open the front door when visited by the investigator.\n* Inability to give informed consent.'}, 'identificationModule': {'nctId': 'NCT05223504', 'briefTitle': 'WARD-Home - Continuous Monitoring of Vital Parameters After Discharge', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'WARD-Home - Continuous Monitoring of Vital Parameters for Early Detection of Complications in Patients Discharged After Acute Medical Hospitalization', 'orgStudyIdInfo': {'id': 'WARD-Home feasibility'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observed patients', 'description': 'Adult patients (≥18 years) admitted with an acute medical disease and who are scheduled for discharge to their own homes within five days from inclusion.', 'interventionNames': ['Device: Continuously monitoring']}], 'interventions': [{'name': 'Continuously monitoring', 'type': 'DEVICE', 'description': 'Included patients are monitored with WARD equipment during the last part of hospitalization and the first days after discharge. Monitoring will last for a maximum of eight days.', 'armGroupLabels': ['Observed patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'København NV', 'state': 'Region H', 'country': 'Denmark', 'facility': 'Bispebjerg and Frederiksberg hospital', 'geoPoint': {'lat': 55.71258, 'lon': 12.52343}}], 'overallOfficials': [{'name': 'Vibeke R Eriksen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technical University of Denmark', 'class': 'OTHER'}, {'name': 'University Hospital Bispebjerg and Frederiksberg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vibeke Eriksen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}