Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT07114458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 404}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-03-16', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delirium', 'timeFrame': 'day 1-5 under isolation precautions', 'description': 'Delirium screened by 3D-Confusion Assessment Method 2 times daily'}], 'secondaryOutcomes': [{'measure': 'Cognitive performance', 'timeFrame': 'at enrollment and six weeks after discharge from hospital', 'description': 'Measures by Montreal Cognitive Assessment (MOCA). Maximum 15, minimum 0 points. Higher points indicate less functional impairment.'}, {'measure': 'Functional state', 'timeFrame': 'at enrollment and six weeks after discharge from hospital', 'description': 'Daily activities and functionality assessed by WHO Disability Assessment Schedule (WHODAS 2.0), a questionnaire with 36-items; answers are on a 5-step-Likert-scale; when values are summed up, higher values indicate a worse functional state'}, {'measure': 'Quality-of-Life (QoL)', 'timeFrame': 'at enrollment and 6 weeks after discharge from hospital', 'description': 'QoL assessed by WHO Quality of Life in older adults (WHO-QOL-OLD) questionnaire'}, {'measure': 'Quality-of-Life (QoL)', 'timeFrame': 'at enrollment and 6 weeks after discharge from hospital', 'description': 'QoL assessed by Visual Analogue Scale from EQ-5D-5L questionnaire (no abbreviation); Maximum 100 points, minimum 0 points; more points indicate a better QoL.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delirium', 'neurocognitive disorder', 'older adult', 'isolation precautions'], 'conditions': ['Delirium', 'Dementia', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to examine if older patients who need to be under isolation precautions due to multidrug resistant bacteria or other reasons have an increased risk of suffering from delirium or cognitive decline compared to older patients without isolation precautions.\n\nTo compare this, every person under isolation precautions is compared to other persons of the same age, gender, comorbidities, frailty status and hospital department. Delirium is assessed twice daily with a screening tool named 3D-CAM and cognitive performance is tested by the MOCA-Test six weeks after discharge from hospital and compared to baseline values which are assessed directly after study enrollment.\n\nThe study duration for each patient participating is from the time of enrollment during hospitalization until 6 weeks after hospital discharge.', 'detailedDescription': 'Delirium is a common complication in older patients during hospitalization. Its prevention is crucial, as it increases morbidity, mortality, and cognitive impairment. Isolation precautions in hospital may further increase delirium risk due to sensory deprivation and reduced mobility.\n\nThis study examines the impact of isolation precautions on delirium and neurocognitive disorders in patients ≥70 years. Delirium screening will occur twice daily, with a six-week post-discharge follow-up.\n\nA prospective cohort study will compare delirium incidence in isolated patients with a matched non-isolated control group (matched for age, gender, Charlson Comorbidity Index, Frailty and hospital department). The 3D Confusion Assessment Method (3D-CAM) will be used for Delirium screening. Follow-up assessments will evaluate cognitive function and quality of life. Data will be collected during hospitalization (Days 1-5) and six weeks post-discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospitalized patients of the University Medical Centre Hamburg (all departments)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - hospitalized patients\n\n* under isolation precautions for at least 24h\n* 70 years and above\n\nExclusion Criteria: - no informed consent\n\n* intensive care treatment\n* life expectancy 14 days or less'}, 'identificationModule': {'nctId': 'NCT07114458', 'acronym': 'DELiso', 'briefTitle': 'Delirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Delirium Incidence and Cognitive Trajectories in Isolated Older Patients in the Inpatient Setting', 'orgStudyIdInfo': {'id': '2024-101313-BO-ff'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposition', 'description': 'Patients under isolation precautions in hospital'}, {'label': 'Control', 'description': 'Matched control, no isolation precautions'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cynthia Olotu, Dr., MD', 'role': 'CONTACT', 'email': 'c.olotu@uke.de', 'phone': '0049 40 7410 52415'}], 'overallOfficials': [{'name': 'Cynthia Olotu, Dr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Hamburg, Department of Anaesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}