Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 8:27 AM
Study NCT ID:
NCT01699503
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Indiana University Dementia Screening Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fowlern@iupui.edu', 'phone': '317-274-9021', 'title': 'Dr. Nicole Fowler', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Screening Group', 'description': 'Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.\n\nCollaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.', 'otherNumAtRisk': 1723, 'deathsNumAtRisk': 1723, 'otherNumAffected': 0, 'seriousNumAtRisk': 1723, 'deathsNumAffected': 21, 'seriousNumAffected': 52}, {'id': 'EG001', 'title': 'No Screening', 'description': 'Subjects who are randomized into the non-screening arm will receive the usual standard of care.', 'otherNumAtRisk': 1693, 'deathsNumAtRisk': 1693, 'otherNumAffected': 0, 'seriousNumAtRisk': 1693, 'deathsNumAffected': 25, 'seriousNumAffected': 47}], 'seriousEvents': [{'term': 'Incident Severe Depression (', 'notes': 'Severe Depression is defined as PHQ-9 score of 15+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 1693, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Incident Severe Anxiety', 'notes': 'Severe Anxiety is defined as GAD-7 score of 15 - 21', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1693, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Health Related Quality of Life (HRQOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.\n\nCollaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.'}, {'id': 'OG001', 'title': 'No Screening', 'description': 'Subjects who are randomized into the non-screening arm will receive the usual standard of care.'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}, {'value': '1000', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '885', 'groupId': 'OG000'}, {'value': '875', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '993', 'groupId': 'OG000'}, {'value': '976', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month, 6 months, 12 months', 'description': "The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.'}, {'type': 'PRIMARY', 'title': 'Patient Health Questionnaire (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.\n\nCollaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.'}, {'id': 'OG001', 'title': 'No Screening', 'description': 'Subjects who are randomized into the non-screening arm will receive the usual standard of care.'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'OG000'}, {'value': '1022', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.33', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '3.27', 'groupId': 'OG001'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}, {'value': '893', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.50', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '2.45', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1006', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.74', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '3.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month, 6 months, 12 months', 'description': 'The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.'}, {'type': 'PRIMARY', 'title': 'Generalized Anxiety Disorder Scale (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.\n\nCollaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.'}, {'id': 'OG001', 'title': 'No Screening', 'description': 'Subjects who are randomized into the non-screening arm will receive the usual standard of care.'}], 'classes': [{'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '997', 'groupId': 'OG000'}, {'value': '1022', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.16', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '2.54', 'groupId': 'OG001'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}, {'value': '893', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.24', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': '12 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1005', 'groupId': 'OG000'}, {'value': '992', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.31', 'spread': '2.77', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '2.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month, 6 months, 12 months', 'description': 'The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Health Care Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1693', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.\n\nCollaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.'}, {'id': 'OG001', 'title': 'No Screening', 'description': 'Subjects who are randomized into the non-screening arm will receive the usual standard of care.'}], 'classes': [{'title': 'Patients with at least 1 ED visit in 12 months', 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}]}]}, {'title': 'Patients with at least 1 hospitalization in 12 mo', 'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Advance Directive at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '992', 'groupId': 'OG000'}, {'value': '1008', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.\n\nCollaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.'}, {'id': 'OG001', 'title': 'No Screening', 'description': 'Subjects who are randomized into the non-screening arm will receive the usual standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '653', 'groupId': 'OG000'}, {'value': '644', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': "The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at 12 months.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Screening Group', 'description': 'Subjects who are randomized into the screening arm of the study will be screened by the Memory Impairment Screen (MIS). Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.\n\nCollaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.'}, {'id': 'FG001', 'title': 'No Screening', 'description': 'Subjects who are randomized into the non-screening arm will receive the usual standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2008'}, {'groupId': 'FG001', 'numSubjects': '1997'}]}, {'type': 'Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1723'}, {'groupId': 'FG001', 'numSubjects': '1693'}]}, {'type': '1 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '998'}, {'groupId': 'FG001', 'numSubjects': '1022'}]}, {'type': '6 Month Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '903'}, {'groupId': 'FG001', 'numSubjects': '893'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1008'}, {'groupId': 'FG001', 'numSubjects': '992'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1000'}, {'groupId': 'FG001', 'numSubjects': '1005'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'Excluded due to quality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '783'}, {'groupId': 'FG001', 'numSubjects': '791'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Screening Group', 'description': 'Subjects who are randomized into the screening arm of the study will be screened by the Memory Impairment Screen(MIS). Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.\n\nCollaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.'}, {'id': 'BG001', 'title': 'No Screening', 'description': 'Subjects who are randomized into the non-screening arm will receive the usual standard of care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '74.1', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '74.1', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1167', 'groupId': 'BG000'}, {'value': '1089', 'groupId': 'BG001'}, {'value': '2256', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '556', 'groupId': 'BG000'}, {'value': '604', 'groupId': 'BG001'}, {'value': '1160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Black', 'measurements': [{'value': '526', 'groupId': 'BG000'}, {'value': '530', 'groupId': 'BG001'}, {'value': '1056', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1164', 'groupId': 'BG000'}, {'value': '1137', 'groupId': 'BG001'}, {'value': '2301', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Co-morbidity status, no (%)', 'classes': [{'title': 'Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '379', 'groupId': 'BG000'}, {'value': '392', 'groupId': 'BG001'}, {'value': '771', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Lung Disease/Emphysema/COPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '698', 'groupId': 'BG000'}, {'value': '655', 'groupId': 'BG001'}, {'value': '1353', 'groupId': 'BG002'}]}]}, {'title': 'Congestive Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '612', 'groupId': 'BG002'}]}]}, {'title': 'Peripheral Vascular Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}]}, {'title': 'Coronary Artery Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '567', 'groupId': 'BG000'}, {'value': '585', 'groupId': 'BG001'}, {'value': '1152', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '731', 'groupId': 'BG000'}, {'value': '685', 'groupId': 'BG001'}, {'value': '1416', 'groupId': 'BG002'}]}]}, {'title': 'Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1428', 'groupId': 'BG000'}, {'value': '1383', 'groupId': 'BG001'}, {'value': '2811', 'groupId': 'BG002'}]}]}, {'title': 'Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '390', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '783', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Charlson co-morbidity score, mean (SD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '2.8', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Charlson Comorbidity Index is a method of predicting mortality by classifying or weighting co-morbid conditions. Each of the 12 comorbidity categories has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. Scores range from 0-24. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Education level, no (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1712', 'groupId': 'BG000'}, {'value': '1682', 'groupId': 'BG001'}, {'value': '3394', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Less than high school', 'measurements': [{'value': '363', 'groupId': 'BG000'}, {'value': '357', 'groupId': 'BG001'}, {'value': '720', 'groupId': 'BG002'}]}, {'title': 'High school', 'measurements': [{'value': '571', 'groupId': 'BG000'}, {'value': '556', 'groupId': 'BG001'}, {'value': '1127', 'groupId': 'BG002'}]}, {'title': 'Some college or college degree', 'measurements': [{'value': '778', 'groupId': 'BG000'}, {'value': '769', 'groupId': 'BG001'}, {'value': '1547', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '22 participants refused to answer their education level'}, {'title': 'Self-reported social support¥, mean (SD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.0', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '20.8', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '20.9', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured with the MOS-5 Social Support Inventory. The MOS Social Support Survey, a brief multidimensional self administered instrument, was selected to assess perceived support.The higher the score, the more perceived support. Scores range from 0-100.\n\nCompute raw score by adding scores on these 5 items Raw scores on this scale range from 5-25. Compute transformed score as follows: \\[(Raw score-5)/20\\] x 100', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Study Site, no (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Urban, safety net health system', 'measurements': [{'value': '725', 'groupId': 'BG000'}, {'value': '709', 'groupId': 'BG001'}, {'value': '1434', 'groupId': 'BG002'}]}, {'title': 'Rural health system', 'measurements': [{'value': '653', 'groupId': 'BG000'}, {'value': '624', 'groupId': 'BG001'}, {'value': '1277', 'groupId': 'BG002'}]}, {'title': 'Suburban and urban academic health system', 'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '705', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Health-related quality of life, mean (SD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.27', 'groupId': 'BG000'}, {'value': '0.67', 'spread': '0.27', 'groupId': 'BG001'}, {'value': '0.67', 'spread': '0.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by the Health Utilities Index (HUI). A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death.The HUI classification system is comprised of 8 attributes - Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain - each with 5 or 6 levels of ability/disability.Single-attribute scores of morbidity are defined on a scale such the worst level has a score of 0.00 and the best level has a score of 1.00. The higher the score, the better the health related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Depressive symptoms, mean (SD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.23', 'spread': '4.07', 'groupId': 'BG000'}, {'value': '3.06', 'spread': '3.69', 'groupId': 'BG001'}, {'value': '3.15', 'spread': '3.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by the Patient Health Questionaire-9 (PHQ-9). The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).Scores range from 0-27. A higher score means higher depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Anxiety, mean (SD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1693', 'groupId': 'BG001'}, {'value': '3416', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.79', 'spread': '3.33', 'groupId': 'BG000'}, {'value': '1.77', 'spread': '3.19', 'groupId': 'BG001'}, {'value': '1.78', 'spread': '3.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a valid and efficient tool for screening for Generalized Anxiety Disorder and assessing its severity in clinical practice and research.Scores range from 0-21, with 0-3 points for each of seven questions. A higher score is associated with more severe anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-03-28', 'size': 1495583, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-15T13:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4005}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2012-09-19', 'resultsFirstSubmitDate': '2018-10-31', 'studyFirstSubmitQcDate': '2012-09-30', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-03', 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Related Quality of Life (HRQOL)', 'timeFrame': '1 month, 6 months, 12 months', 'description': "The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health."}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': '1 month, 6 months, 12 months', 'description': 'The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.'}, {'measure': 'Generalized Anxiety Disorder Scale (GAD-7)', 'timeFrame': '1 month, 6 months, 12 months', 'description': 'The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Health Care Utilization', 'timeFrame': '12 months', 'description': 'The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date.'}, {'measure': 'Number of Participants With an Advance Directive at 12 Months', 'timeFrame': '12 months', 'description': "The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at 12 months."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dementia', "Alzheimer's Disease", 'Mild Cognitive Impairment', 'Screening'], 'conditions': ['Dementia', "Alzheimer's Disease", 'Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '18232061', 'type': 'BACKGROUND', 'citation': "Boustani M, Perkins AJ, Monahan P, Fox C, Watson L, Hopkins J, Fultz B, Hui S, Unverzagt FW, Callahan CM, Hendrie HC. Measuring primary care patients' attitudes about dementia screening. Int J Geriatr Psychiatry. 2008 Aug;23(8):812-20. doi: 10.1002/gps.1983."}, {'pmid': '12779304', 'type': 'BACKGROUND', 'citation': 'Boustani M, Peterson B, Hanson L, Harris R, Lohr KN; U.S. Preventive Services Task Force. Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Jun 3;138(11):927-37. doi: 10.7326/0003-4819-138-11-200306030-00015.'}, {'pmid': '21438862', 'type': 'BACKGROUND', 'citation': 'Boustani MA, Justiss MD, Frame A, Austrom MG, Perkins AJ, Cai X, Sachs GA, Torke AM, Monahan P, Hendrie HC. Caregiver and noncaregiver attitudes toward dementia screening. J Am Geriatr Soc. 2011 Apr;59(4):681-6. doi: 10.1111/j.1532-5415.2011.03327.x. Epub 2011 Mar 25.'}, {'pmid': '22690979', 'type': 'BACKGROUND', 'citation': 'Fowler NR, Boustani MA, Frame A, Perkins AJ, Monahan P, Gao S, Sachs GA, Hendrie HC. Effect of patient perceptions on dementia screening in primary care. J Am Geriatr Soc. 2012 Jun;60(6):1037-43. doi: 10.1111/j.1532-5415.2012.03991.x.'}, {'pmid': '31792940', 'type': 'DERIVED', 'citation': 'Fowler NR, Perkins AJ, Gao S, Sachs GA, Boustani MA. Risks and Benefits of Screening for Dementia in Primary Care: The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of Dementia Screening (IU CHOICE)Trial. J Am Geriatr Soc. 2020 Mar;68(3):535-543. doi: 10.1111/jgs.16247. Epub 2019 Dec 2.'}, {'pmid': '24903469', 'type': 'DERIVED', 'citation': 'Fowler NR, Harrawood A, Frame A, Perkins AJ, Gao S, Callahan CM, Sachs GA, French DD, Boustani MA. The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of dementia screening (CHOICE) study: study protocol for a randomized controlled trial. Trials. 2014 Jun 6;15:209. doi: 10.1186/1745-6215-15-209.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to conduct a randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 older adults, cared for in typical, primary care practices.', 'detailedDescription': 'The objective of this proposal is to address the question of whether the benefits outweigh the harms of routine screening for dementia among older adults in primary care when the screening program is coupled with primary care practices prepared to provide care for those who screen positive.\n\nThe specific aim of the study is to conduct a pragmatic randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to deliver best practices dementia care.\n\nPrimary Specific Aim 1:\n\nTest the impact of dementia screening on health-related quality of life of the patient at 12 months.\n\nPrimary Specific Aim 2:\n\nTest the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month (i.e., primary potential harms).\n\nSecondary Aims: Estimate the cost effectiveness of dementia screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults age 65 and older;\n* at least one office visit to their primary care physician within the previous year;\n* no previous diagnosis of dementia or memory problem as determined by ICD-9 codes or the presence of prescription for anti-dementia medications (cholinesterase inhibitors or memantine);\n* ability to consent to participate in the study; and\n* ability to communicate in English\n\nExclusion Criteria:\n\n* adults who are a permanent resident of a nursing facility;\n* a serious mental illness such as bipolar disorder or schizophrenia as determined by the presence of related ICD-9 codes indicative of such an illness; or\n* a pre-existing diagnosis of dementia or cognitive impairment'}, 'identificationModule': {'nctId': 'NCT01699503', 'acronym': 'IU-CHOICE', 'briefTitle': 'Indiana University Dementia Screening Trial', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Indiana University Dementia Screening Trial: The IU CHOICE Study', 'orgStudyIdInfo': {'id': 'R01AG040220-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01AG040220-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01AG040220-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG040220-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Screening', 'description': 'Subjects who are randomized into the non-screening arm will receive the usual standard of care.'}, {'type': 'EXPERIMENTAL', 'label': 'Screening Group', 'description': 'Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.', 'interventionNames': ['Behavioral: Collaborative Dementia Care Program']}], 'interventions': [{'name': 'Collaborative Dementia Care Program', 'type': 'BEHAVIORAL', 'description': 'Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.', 'armGroupLabels': ['Screening Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health-Primary Care Clinics', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Wishard Health Services-Primary Care Clinics', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47904', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health Arnett Primary Care Clinics', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Malaz Boustani, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regenstrief Institute, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Regenstrief Institute, IU Center for Aging Research Scientist', 'investigatorFullName': 'Nicole R. Fowler, PhD', 'investigatorAffiliation': 'Regenstrief Institute, Inc.'}}}}