Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-27 @ 4:05 PM
Study NCT ID:
NCT04962204
Status:
UNKNOWN
Last Update Posted:
2021-10-20
First Post:
2021-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Visitation in Intensive Care Unit Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010820', 'term': 'Physicians'}, {'id': 'D017028', 'term': 'Caregivers'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional group Control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FS-ICU score from caregivers at discharge or 7 days after initiation of study enrolled', 'timeFrame': '7 days', 'description': 'The FS-ICU survey score reflected the satisfaction degree of caregivers. The overall satisfaction score is derived from questions 1 through 24.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Ill Patients']}, 'referencesModule': {'references': [{'pmid': '39283178', 'type': 'DERIVED', 'citation': 'Woo HY, Oh SY, Lim L, Im H, Lee H, Ha EJ, Ryu HG. Efficacy of Virtual Visitation in ICU During COVID-19 Pandemic: The ICU Visits Randomized Controlled Trial. Crit Care Med. 2024 Dec 1;52(12):e593-e603. doi: 10.1097/CCM.0000000000006429. Epub 2024 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify the efficacy of virtual visitation in Intensive Care Unit on patients and their caregivers during COVID-19 Pandemic.', 'detailedDescription': 'After being informed about the study, all patients who meet the eligibility requirements will be randomized in a 1:1 ratio to intervention group (Virtual visitation once a day) or Control group (Phone interviews once a day).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are expected to stay in the intensive care unit for more than 48 hours\n* Patients with a RASS score of -2 or higher\n\nExclusion Criteria:\n\n* Patients who discharge or die within 48 hours of admission to ICU'}, 'identificationModule': {'nctId': 'NCT04962204', 'acronym': 'ISEEU', 'briefTitle': 'Virtual Visitation in Intensive Care Unit Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy of Virtual Visitation in Intensive Care Unit During COVID-19 Pandemic: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2105-188-1224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual visitation group', 'description': 'Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day', 'interventionNames': ['Behavioral: Virtual meeting between patients/physicians and caregiver']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Phone interview between physicians-caregivers once a day'}], 'interventions': [{'name': 'Virtual meeting between patients/physicians and caregiver', 'type': 'BEHAVIORAL', 'description': 'Virtual visits between patients-caregivers and virtual interviews between physicians-caregivers for 15minutes once a day', 'armGroupLabels': ['Virtual visitation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Jongno-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seoul National University Hospital', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Seung-Young Oh', 'role': 'CONTACT', 'email': 'faun1226@gmail.com', 'phone': '+82-2-2072-3538'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Profeessor', 'investigatorFullName': 'Seung-Young Oh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}