Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-30 @ 3:21 PM
Study NCT ID:
NCT05920304
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2023-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Discharge - Evaluating a Virtual Hospital at Home Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking of participants is not possible due to the nature of the study'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a randomized clinical trial. Participants will be randomized in the ratio 1:2 (for each participant randomized to vHaH, there will be two participants randomized to continued conventional in-hospital admission)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity level', 'timeFrame': 'Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment', 'description': 'Daily step count and time in different activity levels will be measured using an accelerometer placed on the thigh of the participant.'}, {'measure': 'Patient mental wellbeing (quantitative)', 'timeFrame': '14 days post discharge', 'description': 'Evaluation through questionnaires'}, {'measure': 'Patient mental wellbeing (qualitative)', 'timeFrame': '14 days post discharge', 'description': 'Evaluation through semi-structured interviews'}, {'measure': 'Patient satisfaction (quantitative)', 'timeFrame': '14 days post discharge', 'description': 'Evaluation through questionnaires'}, {'measure': 'Patient satisfaction (qualitative)', 'timeFrame': '14 days post discharge', 'description': 'Evaluation through semi-structured interviews'}, {'measure': 'Patient perceived safety (quantitative)', 'timeFrame': '14 days post discharge', 'description': 'Evaluation through questionnaires'}, {'measure': 'Patient perceived safety (qualitative)', 'timeFrame': '14 days post discharge', 'description': 'Evaluation through semi-structured interviews'}], 'secondaryOutcomes': [{'measure': 'Demographic characterisation of patients eligible for vHaH', 'timeFrame': '14 days post discharge', 'description': 'Evaluation through questionnaires'}, {'measure': 'Rate of adverse events of special interest (AESI)', 'timeFrame': 'Immediately after discharge', 'description': 'Evaluation through patient record data'}, {'measure': 'Readmittance rate post discharge (30 days and 90 days)', 'timeFrame': '30 and 90 days post discharge', 'description': 'Evaluation through patient record data'}, {'measure': 'Mortality during admission', 'timeFrame': 'daily registration during hospital admission or home-based admission, an average of 5 days after study enrollment', 'description': 'Evaluation through patient record data'}, {'measure': 'Mortality post-discharge (7 days, 30 days, and 90 days)', 'timeFrame': '7, 30 and 90 days post discharge', 'description': 'Evaluation through patient record data'}, {'measure': 'Percentage of timely service delivery in response to red alarms as a sign of clinical deterioration (health workers demonstrate adequate ability in telemedicine service delivery).', 'timeFrame': 'daily registration during home-based admission, an average of 5 days after study enrollment', 'description': 'Data will be extracted from patient-monitoring platform "mit e-hospital" and patient record data'}, {'measure': 'Percentage of scheduled video consultation which were delivered', 'timeFrame': 'daily registration during home-based admission, an average of 5 days after study enrollment', 'description': 'Data will be extracted from patient-monitoring platform "mit e-hospital" and patient record data'}, {'measure': 'Number of patient app deficiencies for participants enrolled in intervention arm', 'timeFrame': 'daily registration during home-based admission, an average of 5 days after study enrollment', 'description': 'Data will be extracted from patient record data'}, {'measure': 'Number of health care provider dashboard deficiencies', 'timeFrame': 'daily registration during home-based admission, an average of 5 days after study enrollment', 'description': 'Data will be extracted from patient record data'}, {'measure': 'Costs related to initiation of home-based admission', 'timeFrame': 'three months post discharge', 'description': 'Economic endpoint'}, {'measure': 'Number of in-hospital days', 'timeFrame': 'three months post discharge', 'description': 'Economic endpoint'}, {'measure': 'Number of outpatient visits', 'timeFrame': 'three months post discharge', 'description': 'Economic endpoint'}, {'measure': 'Costs of hospital resource use', 'timeFrame': 'three months post discharge', 'description': 'Economic endpoint'}, {'measure': 'Number of contacts in primary care (general practitioner, physiotherapy etc.)', 'timeFrame': 'three months post discharge', 'description': 'Economic endpoint'}, {'measure': 'Costs of primary care resource use', 'timeFrame': 'three months post discharge', 'description': 'Economic endpoint'}, {'measure': 'Total costs of health care utilisation per patient', 'timeFrame': 'three months post discharge', 'description': 'Economic endpoint'}, {'measure': 'Health-related Quality of Life', 'timeFrame': 'three months post discharge', 'description': 'Economic endpoint, evaluated using questionnaire EQ-5D-5L (EuroQol, 5 dimensions, 5 levels questionnaire).\n\nOn a scale 1 to 5, a score of 1 indicates the best health state, and higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.'}, {'measure': 'Productivity losses (resources lost when participants work at suboptimal levels or are absent from work)', 'timeFrame': 'three months post discharge', 'description': 'Economic endpoint'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telemedicine', 'Hospital at Home'], 'conditions': ['Epidemic Disease', 'Infections']}, 'referencesModule': {'references': [{'pmid': '40374231', 'type': 'DERIVED', 'citation': 'Larsen MN, Dreisig TS, Rasmussen MK, Christensen ML, Bjerregaard D, von Sydow CD, Nielsen TL, Fischer TK. Telemedicine-supported hospital-at-home for acutely admitted patients at Nordsjaellands Hospital, Denmark: a study protocol for a randomised controlled trial. BMJ Open. 2025 May 14;15(5):e098287. doi: 10.1136/bmjopen-2024-098287.'}]}, 'descriptionModule': {'briefSummary': "This controlled clinical trial will be part of a larger, 'virtual hospital-at-home' (vHaH) project called Influenz-er. vHaH is a care model designed to deliver medical care at home, as a substitute for a continued conventional inpatient hospital admission.\n\nThe overall aim of Influenz-er is to develop, implement and evaluate a novel Hospital at Home model, that will enable safe and satisfactory admission of hospitalised patients including epidemic patients in their homes.", 'detailedDescription': "Various versions of hospital-at-home models have been implemented as an emergency solution to a steep increase in number of hospitalisations during the COVID-19 pandemic crisis. Conventionally, epidemic patients who require medical monitoring, will be admitted to the hospital. Recently, patients hospitalised for COVID-19 requiring medical supervision for an extended period - sometimes for weeks - have been admitted to their own home supported by telemedicine and/or mobile hospital-based care team (MHCT). Various models of home-based admissions of pandemic patients have been implemented internationally with great results regarding safety and effectiveness. These models are mostly based on physical attendance of physicians in the patient's home and in most situations implemented out of need. Home-based models provide promising results regarding costs, but results are based on low-quality evidence. Health systems facing capacity constraints and rising costs needs to allocate resources based on high-quality evidence.\n\nTherefore, further research regarding feasibility, safety, satisfaction, costs, and effectiveness of a vHaH model still needs to be done.\n\nDanish hospital capacity will not allow for HaH models primarily depending on physical attendance of physicians in the patient's home, nor will it be possible to manually monitor all patient reported data. Therefore, there is a need for a telemedicine supported vHaH model with a smart algorithm alarming clinical staff and thereby aiding in timely handling of patient data and clinical state.\n\nProject Influenz-er proposes an option of transfer to telemedicine supported vHaH model as an alternative to continued standard hospital admission for the future. Patient safety is a top priority regarding both the utilised technology and the re-organisation of standard clinical responsibilities and tasks. Therefore, project Influenz-er included several steps prior to the effectiveness evaluation in this clinical trial.\n\nIn the present study, knowledge from previous studies under project Influenz-er is applied, and the vHaH is now ready to be evaluated in an effectiveness trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Patients admitted to\n\n 1. the Department of Pulmonary and Infectious Diseases (DPID) under any diagnosis or\n 2. to the Department of Multimorbidity under any diagnosis\n* Residential address within the catchment area of North Zealand University Hospital\n* Treatment regimen which can be handled within the vHaH model\n\nExclusion Criteria:\n\n* Unstable clinical condition defined by a current early warning score (EWS) \\> 6 or single score = 3.\n* Permanent physical or cognitive impairment or observed non-compliance that might negatively affect the ability to perform any of the required actions during the intervention such as self-measurements, data transfer by the app, and/or communication via telephone or video consultation.\n\n a. This may include, but is not limited to conditions such as dementia, post-stroke sequelae, deafness, extreme tremor of the upper limbs.\n* Unproficiency in Danish language skills\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05920304', 'briefTitle': 'Early Discharge - Evaluating a Virtual Hospital at Home Model', 'organization': {'class': 'OTHER', 'fullName': 'Nordsjaellands Hospital'}, 'officialTitle': 'Early Discharge - a Randomised Controlled Trial Evaluating Mental and Physical Effects on Acutely and Chronically Ill Patients in a Telemedicine Supported Virtual Hospital at Home Model', 'orgStudyIdInfo': {'id': 'Influenz-er 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virtual Hospital at Home (vHaH)', 'description': 'Participants are transferred home for telemedicine supported home-based admission.', 'interventionNames': ['Device: virtual Hospital at Home (vHaH)']}, {'type': 'NO_INTERVENTION', 'label': 'Continued conventional hospitalisation', 'description': 'Participants will follow a conventional hospital admission.'}], 'interventions': [{'name': 'virtual Hospital at Home (vHaH)', 'type': 'DEVICE', 'otherNames': ['mit e-hospital'], 'description': "Participants randomized to vHaH will transferred home for home-based admission. Participants will be provided with equipment for self-monitoring (respiratory rate, oxygen saturation, blood pressure, heart rate and temperature). They will receive an app on their smartphone or tablet for transferring of self-measurements and communication with the hospital during their home-based admission.\n\nSupporting the telemedicine concept, a mobile hospital-based care team will perform clinical tasks including intravenous administration, blood samples and on-site clinical assessment in the participant's home, when relevant.\n\nDaily ward rounds will be conducted as video consultations. Before leaving the hospital, participants will receive thorough education on how to self-monitor and how to use the app.", 'armGroupLabels': ['virtual Hospital at Home (vHaH)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Christian S Skjoldvang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital'}, {'name': 'Miljena Copois, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '5 years from study onset', 'ipdSharing': 'YES', 'description': 'Personally identifiable data will be shared with researcher at University of Southern Denmark in accordance with our "data processing agreement" approved by lawyers of the Capital Region of Denmark.', 'accessCriteria': 'Data will be stored in the database management system, REDCap, where certain researchers can access data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovation Fund Denmark', 'class': 'INDIV'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}