Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
Study NCT ID:
NCT04740567
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2021-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Cognitive Intervention in Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jin.h.han@vumc.org', 'phone': '615-936-0253', 'title': 'Jin H. Han', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limited generalizability since our study was conducted at a quartnerary hospital in the South. Mortality was different between the intervention vs usual care group and overall attrition rate was high for both groups, which may have biased our estimates.'}}, 'adverseEventsModule': {'timeFrame': 'From enrollment to the 4-month follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'deathsNumAffected': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.', 'otherNumAtRisk': 186, 'deathsNumAtRisk': 186, 'otherNumAffected': 0, 'seriousNumAtRisk': 186, 'deathsNumAffected': 43, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '80'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-months', 'description': 'A neuropsychological battery for global cognition which evaluates immediate and delayed memory, attention, visuospatial construction, and language. Scores range from 40 to 160, with higher scores indicating better cognition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '8'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-months', 'description': "The D-KEF's Proverbs, Color Word Interference, and Verbal Fluency Category Switching subscales will measure conceptual flexibility, inhibition, and monitoring, respecitvely, which encompasses the majority of executive function. The average of the three subscales will provide an executive function composite score. Scores range from 1 to 18 with higher values indicating better executive function", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '16'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-months', 'description': 'Characterizes seven basic and seven instrumental activities of daily living. Scores range from 0 to 28 with higher scores indicating better functional status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient surrogates were able to complete this assessment which is why the total N is higher than the total number with completed outcomes.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Measured by the EQ-5D-5L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.352', 'groupId': 'OG000', 'lowerLimit': '0.096', 'upperLimit': '0.727'}, {'value': '0.269', 'groupId': 'OG001', 'lowerLimit': '0.096', 'upperLimit': '0.465'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-months', 'description': 'Characterizes quality of life and contains 5-dimensions ("5D") related to everyday living: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It asks patients to rate their current global health status from 0 (worst health you can imagine) to 100 (best health you can imagine). Scores range from -0.573 to 1.000 with higher scores indicating better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vital Status (Dead / Alive)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-months', 'description': 'Death within 4-months will be recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were randomized were included in the mortality outcome analysis.'}, {'type': 'SECONDARY', 'title': 'Nursing Home Placement (Yes / no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-months', 'description': 'Nursing home placement within 4-months will be recorded', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were randomized included in the nursing home analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Montreal Cognitive Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6.5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-months', 'description': 'Change in global cognition at 4-months compared to enrollment. The Montreal Cognitive Assessment assesses visuospatial, language, naming, memory, attention, abstraction, and orientation, and ranges from 0 to 30 (perfect cognition). It was collected at enrollment, during the delirium episode, and at 4 months.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '\\# randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'COMPLETED', 'comment': '\\# with primary outcome completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '84'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Patient declined to participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Patient was physically incapable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': "Patient's spouse was had prolongued ICU stay", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000', 'lowerLimit': '71', 'upperLimit': '82'}, {'value': '75', 'groupId': 'BG001', 'lowerLimit': '70.3', 'upperLimit': '82.0'}, {'value': '75', 'groupId': 'BG002', 'lowerLimit': '71', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-04', 'size': 439203, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-23T09:53', 'hasProtocol': True}, {'date': '2024-11-14', 'size': 245316, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-09T10:55', 'hasProtocol': False}, {'date': '2023-04-04', 'size': 506126, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-20T21:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2021-02-01', 'resultsFirstSubmitDate': '2025-11-11', 'studyFirstSubmitQcDate': '2021-02-01', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-12-23', 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'timeFrame': '4-months', 'description': 'A neuropsychological battery for global cognition which evaluates immediate and delayed memory, attention, visuospatial construction, and language. Scores range from 40 to 160, with higher scores indicating better cognition.'}], 'secondaryOutcomes': [{'measure': 'Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales', 'timeFrame': '4-months', 'description': "The D-KEF's Proverbs, Color Word Interference, and Verbal Fluency Category Switching subscales will measure conceptual flexibility, inhibition, and monitoring, respecitvely, which encompasses the majority of executive function. The average of the three subscales will provide an executive function composite score. Scores range from 1 to 18 with higher values indicating better executive function"}, {'measure': 'Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale', 'timeFrame': '4-months', 'description': 'Characterizes seven basic and seven instrumental activities of daily living. Scores range from 0 to 28 with higher scores indicating better functional status.'}, {'measure': 'Quality of Life as Measured by the EQ-5D-5L', 'timeFrame': '4-months', 'description': 'Characterizes quality of life and contains 5-dimensions ("5D") related to everyday living: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It asks patients to rate their current global health status from 0 (worst health you can imagine) to 100 (best health you can imagine). Scores range from -0.573 to 1.000 with higher scores indicating better quality of life.'}, {'measure': 'Vital Status (Dead / Alive)', 'timeFrame': '4-months', 'description': 'Death within 4-months will be recorded'}, {'measure': 'Nursing Home Placement (Yes / no)', 'timeFrame': '4-months', 'description': 'Nursing home placement within 4-months will be recorded'}, {'measure': 'Change in Montreal Cognitive Assessment', 'timeFrame': '4-months', 'description': 'Change in global cognition at 4-months compared to enrollment. The Montreal Cognitive Assessment assesses visuospatial, language, naming, memory, attention, abstraction, and orientation, and ranges from 0 to 30 (perfect cognition). It was collected at enrollment, during the delirium episode, and at 4 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Cognitive Decline', 'Dementia']}, 'descriptionModule': {'briefSummary': "This is a randomized control trial to determine if early cognitive training and rehabilitation improve 4-month cognition in hospitalized older (\\>=65 years old) delirious patients with and without Alzheimer's disease and related dementias. Enrolled patients will be randomized to receive cognitive intervention versus usual care at a 1:2 allocation ratio. Patients assigned to the cognitive intervention group will receive cognitive training daily during hospitalization and cognitive rehabilitation weekly for 12 weeks after hospital discharge. Patients will be evaluated for global cognition (primary outcome) and secondary outcomes at 4-months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 65 years or older\n* Admitted through the ED\n* Cognitive training can be initiated within 24 hours of ED presentation\n* Delirious at enrollment\n\nExclusion Criteria:\n\n* Comatose\n* Not able to follow simple commands or non-verbal prior to the acute illness (end-stage pre-illness ADRD)\n* Resides in a nursing home\n* Prisoner\n* Receiving hospice care\n* Lives \\> 100 miles away from the enrolling sites\n* Non-English speaking\n* Previously enrolled\n* Deaf or blind\n* Intravenous drug, crack or cocaine, or methamphetamine use within the past one year, or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.\n* Psychotic disorder or suicidal gesture requiring hospitalization with the past one year\n* Discharged from the ED"}, 'identificationModule': {'nctId': 'NCT04740567', 'acronym': 'ECID', 'briefTitle': 'Early Cognitive Intervention in Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Early Cognitive Training and Rehabilitation to Improve Long-term Cognitive Outcomes in Older Hospitalized Adults With Delirium', 'orgStudyIdInfo': {'id': '192498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Intervention', 'description': 'During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.', 'interventionNames': ['Behavioral: Cognitive Training', 'Behavioral: Goal Management Training']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.'}], 'interventions': [{'name': 'Cognitive Training', 'type': 'BEHAVIORAL', 'description': "The cognitive training program regimen and its degree of difficulty will be tailored to the patient's current level of cognitive functioning and interests. Patients will be asked to work through progressively more challenging exercises pertaining to orientation, attention, problem-solving, and memory. These cognitive training exercises will be significantly difficult but when they can be completed easily (\\>85% mastery), their difficulty will be increased, and this process will be repeated as appropriate. They will also perform puzzles, games, or cognitive tasks related to their hobbies.", 'armGroupLabels': ['Cognitive Intervention']}, {'name': 'Goal Management Training', 'type': 'BEHAVIORAL', 'description': 'Goal management training will (1) teach patients compensatory strategies such as "stop" techniques \\[e.g., to "stop and think" about consequences of a decision before making it\\]; (2) help them to take complex tasks and divide them into manageable subtasks to increase the likelihood of completing the task; and (3) enable them to learn to regain cognitive control when their behavior becomes incompatible with their intended goals. GMT is anchored in "sustained and vigilant attention theory" and it enables patients to actively attend to "higher order" goals critical to functioning. GMT is tailored to the individual needs of the patient. During the initial session, the Cognitive Intervention Specialist will meet with the subject and their family member or caregiver to identify these functional and cognitive deficiencies.', 'armGroupLabels': ['Cognitive Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37027', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Valley Healthcare System - Nashville Veteran Affairs Hospital', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37027', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Jin H Han, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'James C Jackson, PsyD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Deidentified data will be made available two years after publication. Supporting documents will be made available at the time of publication of the primary manuscript.', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jin H. Han', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}