Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT03066232
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2017-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delirium in Home-dwelling Old People Receiving Home Nursing Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003704', 'term': 'Dementia'}], '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': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'EDTA blood samples serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2017-02-20', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trajectory of cognitive function using the MoCa test', 'timeFrame': '2 years', 'description': 'The impact of an episode of delirium upon cognitive function measured by the Montreal Cognitive Assessment every 6th months for two years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delirium', 'Dementia', 'Physical function'], 'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': 'Study the prevalence of delirium among old persons with home-nursing care living in the community. By recruiting the persons in a stable phase, the investigators wish to study the influence of an episode of delirium upon further cognitive and physical function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons older than 65 years living in their own home receiving home nursing care at least once a week.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Home nursing service at least once a week.\n* Home dwelling (not permanently institutionalised)\n* Age 65 years or more\n* Informed consent by the patient or a close relative (if the patient is unable to give a valid informed consent)\n\nExclusion Criteria:\n\n* Patient or relative denies inclusion\n* Terminal illness\n* Patients diagnosed with dementia with Lewy bodies (its fluctuating course makes the diagnosis of delirium challenging)\n* Patients with chronic diseases that have needed assistance from the home nursing service before the age of 65.\n* Assistance from the home nursing service is due to addictive substances.\n* Assistance from the home nursing service is due to psychiatric illnesses other than dementia.'}, 'identificationModule': {'nctId': 'NCT03066232', 'briefTitle': 'Delirium in Home-dwelling Old People Receiving Home Nursing Care', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Delirium in Home-dwelling Old People Receiving Home Nursing Care', 'orgStudyIdInfo': {'id': '2014/1972'}}, 'contactsLocationsModule': {'locations': [{'city': 'Sandefjord', 'country': 'Norway', 'facility': 'Sandefjord kommune', 'geoPoint': {'lat': 59.13118, 'lon': 10.21665}}], 'overallOfficials': [{'name': 'Torgeir Bruun Wyller, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital, University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sandefjord kommune', 'class': 'UNKNOWN'}, {'name': 'Norwegian Centre for Ageing and Health', 'class': 'OTHER'}, {'name': 'The Hospital of Vestfold', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Maria Krogseth', 'investigatorAffiliation': 'Oslo University Hospital'}}}}