Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT04910334
Status:
UNKNOWN
Last Update Posted:
2021-06-02
First Post:
2021-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Cognitive and Functional Status After COVID-19 Treatment at Danish ICUs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 203}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-01', 'studyFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA', 'timeFrame': 'at 6 and 12 months after ICU admission', 'description': 'The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA. Score 0-15, score above 11 indicate normal cognitive function. Two time points to see if there is a change in the cognitive status over time.'}, {'measure': 'The functional status at 6 and 12 months after ICU admission using the validated instrument CFS', 'timeFrame': 'at 6 and 12 months after ICU admission', 'description': 'The functional status at 6 and 12 months after ICU admission using the validated instrument CFS (score 1-9) higher levels indicate more frailty. Two time points to see if there is a change in the frailty status over time.'}], 'secondaryOutcomes': [{'measure': 'The association between ventilator days and CFS 6 and 12 months after ICU admission', 'timeFrame': 'at 6 and 12 months after ICU admission', 'description': 'The association between ventilator days and CFS 6 and 12 months after ICU admission. Will be one analysis.'}, {'measure': 'The association between ventilator days and MiniMoCA 6 and 12 months after ICU admission', 'timeFrame': 'at 6 and 12 months after ICU admission', 'description': 'The association between ventilator days and MiniMoCA 6 and 12 months after ICU admission. Will be one analysis. But need to time points to see if there is a change.'}, {'measure': 'Mortality 6 and 12 months after ICU admission', 'timeFrame': 'at 6 and 12 months after ICU admission', 'description': 'Mortality 6 and 12 months after ICU admission. To see if there is a change i mortality at 6 and 12 months.'}, {'measure': 'EQ-5D-5L score 6 and 12 months after ICU admission', 'timeFrame': 'at 6 and 12 months after ICU admission', 'description': 'EQ-5D-5L score 6 and 12 months after ICU admission. Score 5-25. low score indicate better quality of life. Two time points to see if there is a change.'}, {'measure': 'Barthel ADL score 6 and 12 months after ICU admission', 'timeFrame': 'at 6 and 12 months after ICU admission', 'description': 'Barthel ADL score 6 and 12 months after ICU admission. Score 0-20, high score indicate high independence. Two time points to see if there is a change.'}, {'measure': 'Lawton-Brody IADL score 6 and 12 months after ICU admission', 'timeFrame': 'at 6 and 12 months after ICU admission', 'description': 'Lawton-Brody IADL score 6 and 12 months after ICU admission. score from 0-8 for female and 0-5 for male. High score indicate high independence. Two time points to see if there is a change.'}, {'measure': 'FAS score 6 and 12 months after ICU admission', 'timeFrame': 'at 6 and 12 months after ICU admission', 'description': 'FAS score 6 and 12 months after ICU admission. score from 10-50, high score indicate high level of fatigue. Two time points to see if there is a change.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19', 'danish icu', 'long-term follow-up'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This study is a prospective observational cohort study of 6 and 12 months long-term outcome of Danish speaking patients with COVID-19.', 'detailedDescription': 'To describe frailty, cognitive function, functional status, fatigue, mortality and the quality of life 6 and 12 months after ICU admission of the COVID-19 patients enrolled in the Danish ICU COVID-19 database. Furthermore to investigate the association between ventilator days and Clinical Frailty Score (CFS) and the MiniMoCA, respectively at 6 and 12 months after ICU admission'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population is all Danish speaking COVID-19 patients, admitted and treated at one of the 29 Danish ICUs, and enrolled in the 'Danish ICU COVID-19 database' from March 10th and forward. Patients are 18 of age and above with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 either prior to or during ICU admission", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\> 18 years\n* enrolled in the 'Danish ICU COVID-19 database'\n\nExclusion Criteria:\n\n* non danish speaking patients"}, 'identificationModule': {'nctId': 'NCT04910334', 'briefTitle': 'Long-term Cognitive and Functional Status After COVID-19 Treatment at Danish ICUs', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Long-term Cognitive and Functional Status After COVID-19 Treatment at Danish ICUs', 'orgStudyIdInfo': {'id': 'REG-135-2020'}}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Department of Anaesthesiology', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}], 'overallOfficials': [{'name': 'Lone Poulsen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}