Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-03-06 @ 7:20 AM
Study NCT ID:
NCT03317106
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2017-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}], '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': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 943}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2017-10-18', 'studyFirstSubmitQcDate': '2017-10-18', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean K-DRS-R98 score', 'timeFrame': '3 weeks', 'description': 'mean score of delirium severity rating scale during follow up period. Detailed information about scale: Korean Version of the Delirium Rating Scale-Revised-98(K-DRS-R98) DRS-R98 proved to be a valid and reliable instrument for the assessment of delirium severity and distinguish patients with delirium from non-delirious patients including dementia. The scale is composed of two sections. The first section is the severity scale, which consists of 13 items that are scored from 0 to 3 according to a Likert scale that is anchored by descriptions of phe-nomenology. The second section consists of three diagnostic items that are scored from 0 to 2 or 3. These items include temporal onset of symptoms, fluctuation of symptom severity and physical disorder. The total scale is comprised of 16 items. The total score is the sum of the scores for each item and the higher the score, the greater the severity.'}]}, 'conditionsModule': {'conditions': ['Delirium', 'Cerebral Infarction']}, 'descriptionModule': {'briefSummary': 'this study examines the incidence of newly developed delirium in patients who admit to university hospital stroke unit for cerebral infarction, and analyze the association between delirium motor subtypes and short-term outcome in post-stroke delirium patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital.\n\nExclusion Criteria:\n\n* Any patients who refuse to enroll the study.\n* Any patients who admit to Intensive Care Unit(ICU), because ICU is well-known for precipitating delirium.'}, 'identificationModule': {'nctId': 'NCT03317106', 'briefTitle': 'the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chungnam National University Hospital'}, 'officialTitle': 'the Prospective Study on the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients', 'orgStudyIdInfo': {'id': '2017-07-058'}}, 'contactsLocationsModule': {'locations': [{'city': 'Daejeon', 'state': 'Munhwa-ro 282, Jung-gu', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}], 'overallOfficials': [{'name': 'Jeonglan Kim', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chungnam National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heewon Yang', 'investigatorAffiliation': 'Chungnam National University Hospital'}}}}