Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT01434667
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2011-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kchristensen@bwh.harvard.edu', 'phone': '(617) 264-5883', 'title': 'Kurt Christensen, PhD', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "From enrollment through 6 months after the Alzheimer's disease risk assessment.", 'description': 'Non-serious adverse events were defined as scores at any time including baseline, on psychological outcome scales greater than or equal to 56 on the STAI (anxiety), 8 on the GDS (depression) or 2 on the BHS (hopelessness). Non-serious adverse events were identified at the judgment of study personnel as events that caused inconvenience or concern to participants, but did not qualify as serious. Serious adverse events were defined per guidelines from the National Institutes of Aging.', 'eventGroups': [{'id': 'EG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.", 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 16, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.", 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 18, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased monitoring due to high scores on anxiety, depression or hopelessness scales', 'notes': 'Scores at any time point of 56 or higher on the 6-item State-Trait Anxiety Index (STAI), 8 or higher on the 15-item Geriatric Depression Scale (GDS), and 2 or higher on the 4-item Beck Hopelessness Scale (BHS).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed disclosure session', 'notes': "Extended delay of disclosure of Alzheimer's disease risk assessment", 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geriatric Depression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': '6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks post-disclosure, and 6 months post-disclosure', 'description': 'A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the full 15-item scale.'}, {'type': 'PRIMARY', 'title': 'Mini State Trait Anxiety Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.3', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '36.5', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '11.8', 'groupId': 'OG001'}]}]}, {'title': '6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.2', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '36.2', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks post-disclosure, and 6 months post-disclosure', 'description': 'Validated introspective psychological inventory consisting of 6 self-report items pertaining to anxiety affect. Responses are transformed into scores that range from 20 to 80, with higher scores indicating greater anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the full 6-item scale'}, {'type': 'SECONDARY', 'title': 'Impact of Event Scale (IES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': '1-3 Days Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '12.6', 'groupId': 'OG001'}]}]}, {'title': '6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.5', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '12.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-3 Days, 6 Weeks and 6 Months Post-disclosure', 'description': 'The Impact of Event assesses intrusive thoughts and avoidance related to a specific stressful life event. It is a 15-item self-report measure with scores that range from 0 to 75, with greater scores indicating greater distress about the event.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the full 15-item scale.'}, {'type': 'SECONDARY', 'title': 'Psychological Impact of Test Disclosure (IGT-AD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': '6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.7', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': '6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.1', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '11.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks and 6 Months Post-disclosure', 'description': 'A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress. Higher scores indicate greater distress about the risk assessment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the full 15-item scale'}, {'type': 'SECONDARY', 'title': 'Recall and Comprehension of Risk Information', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': '6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': '6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks and 6 Months Post-disclosure', 'description': 'Several measures to assess participant recall and comprehension of personalized risk information for AD. The sum number correct of the two items that were presented to both randomization arms ("What form of APOE increases risk for Alzheimer\'s disease?", and "What percentage were you given as your 3-year risk of developing Alzheimer\'s disease?") are summarized here.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who provided data on each scale.'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': 'Information: 6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Explanation: 6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Reassurance: 6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Advice: 6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Help in decision making: 6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Information: 6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Explanation: 6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Reassurance: 6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Advice: 6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Help in decision making: 6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks and 6 Months Post-disclosure', 'description': "How well participants' expectations about information, explanations, reassurance, advice, and help in decision making were met. Participants rated satisfaction for each dimension on a 1-7 scale, with higher scores indicating that expectations were met better.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who provided responses on each expectation item'}, {'type': 'SECONDARY', 'title': 'User Ratings of Risk Assessment Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': '6 Weeks Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': '6 Months Post-Disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Weeks and 6 Months Post-disclosure', 'description': 'Subjective ratings of the impact of risk assessment. Participants provided ratings on a 1-5 scale, with 1 being "very negative" and 5 being "very positive"', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed these items in the post-disclosure surveys.'}, {'type': 'SECONDARY', 'title': 'Health Behavior and Insurance Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': 'Baseline: Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Physical activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Dietary supplements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Mental activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Stress management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks post-disclosure: Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks post-disclosure: Physical activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks post-disclosure: Dietary supplements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks post-disclosure: Mental activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks post-disclosure: Stress management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks post-disclosure: Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': '6 Months post-disclosure: Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '6 Months post-disclosure: Physical activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '6 Months post-disclosure: Dietary supplements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '6 Months post-disclosure: Mental activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': '6 Months post-disclosure: Stress management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '6 Months post-disclosure: Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 6 weeks post-disclosure, and 6 months post-disclosure', 'description': 'AD prevention behaviors enacted within the prior two weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who provided data on health behaviors at each time point.'}, {'type': 'SECONDARY', 'title': 'Insurance and Advance Planning Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': 'Health insurance change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Life insurance change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Short-term disability insurance change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Long-term disability insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Long-term care insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change to will', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change to living will', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Change to durable power of attorney', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post-disclosure', 'description': 'A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who provided data on the 6-month follow-up survey about these outcomes'}, {'type': 'SECONDARY', 'title': "Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'OG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'classes': [{'title': '6 Weeks post-disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '6 Months post-disclosure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks and 6 months post-disclosure', 'description': 'Yes/no response to the question, "Since receiving your Alzheimer\'s disease risk estimate, have you joined any other Alzheimer\'s disease-related research studies?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who provided data on these survey items'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apolipoprotein E (APOE) Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'FG001', 'title': 'Apolipoprotein E (APOE) Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'preAssignmentDetails': '32 enrolled participants were not assigned for the reasons that follow:\n\nIneligible (n=7)\n\n* No study partner: 5\n* Diagnosis was not amnestic mild cognitive impairment (MCI): 1\n* Low cognitive score: 1\n\nDeclined to continue (n=17)\n\n* No longer interested: n=11\n* Too busy: 4\n* No reason given: 2\n\nLost to follow-up (n=8)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.\n\nAlzheimer's disease risk disclosure: Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'id': 'BG001', 'title': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.\n\nAPOE genotype and Alzheimer's disease risk disclosure: Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."}, {'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': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.1', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '73.3', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '73.9', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-identified race', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2011-09-07', 'resultsFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2011-09-14', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-24', 'studyFirstPostDateStruct': {'date': '2011-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geriatric Depression Scale', 'timeFrame': 'Baseline, 6 weeks post-disclosure, and 6 months post-disclosure', 'description': 'A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression.'}, {'measure': 'Mini State Trait Anxiety Inventory', 'timeFrame': 'Baseline, 6 weeks post-disclosure, and 6 months post-disclosure', 'description': 'Validated introspective psychological inventory consisting of 6 self-report items pertaining to anxiety affect. Responses are transformed into scores that range from 20 to 80, with higher scores indicating greater anxiety.'}], 'secondaryOutcomes': [{'measure': 'Impact of Event Scale (IES)', 'timeFrame': '1-3 Days, 6 Weeks and 6 Months Post-disclosure', 'description': 'The Impact of Event assesses intrusive thoughts and avoidance related to a specific stressful life event. It is a 15-item self-report measure with scores that range from 0 to 75, with greater scores indicating greater distress about the event.'}, {'measure': 'Psychological Impact of Test Disclosure (IGT-AD)', 'timeFrame': '6 Weeks and 6 Months Post-disclosure', 'description': 'A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress. Higher scores indicate greater distress about the risk assessment.'}, {'measure': 'Recall and Comprehension of Risk Information', 'timeFrame': '6 Weeks and 6 Months Post-disclosure', 'description': 'Several measures to assess participant recall and comprehension of personalized risk information for AD. The sum number correct of the two items that were presented to both randomization arms ("What form of APOE increases risk for Alzheimer\'s disease?", and "What percentage were you given as your 3-year risk of developing Alzheimer\'s disease?") are summarized here.'}, {'measure': 'Participant Satisfaction', 'timeFrame': '6 Weeks and 6 Months Post-disclosure', 'description': "How well participants' expectations about information, explanations, reassurance, advice, and help in decision making were met. Participants rated satisfaction for each dimension on a 1-7 scale, with higher scores indicating that expectations were met better."}, {'measure': 'User Ratings of Risk Assessment Experience', 'timeFrame': '6 Weeks and 6 Months Post-disclosure', 'description': 'Subjective ratings of the impact of risk assessment. Participants provided ratings on a 1-5 scale, with 1 being "very negative" and 5 being "very positive"'}, {'measure': 'Health Behavior and Insurance Changes', 'timeFrame': 'Baseline, 6 weeks post-disclosure, and 6 months post-disclosure', 'description': 'AD prevention behaviors enacted within the prior two weeks.'}, {'measure': 'Insurance and Advance Planning Changes', 'timeFrame': '6 months post-disclosure', 'description': 'A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.'}, {'measure': "Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.", 'timeFrame': '6 weeks and 6 months post-disclosure', 'description': 'Yes/no response to the question, "Since receiving your Alzheimer\'s disease risk estimate, have you joined any other Alzheimer\'s disease-related research studies?"'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment (MCI)', "Alzheimer's disease (AD)", 'APOE', 'genetics', 'risk assessment', 'education', 'genetic counseling', 'Mild Cognitive Impairment, So Stated'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '20679636', 'type': 'BACKGROUND', 'citation': 'Roberts JS, Karlawish JH, Uhlmann WR, Petersen RC, Green RC. Mild cognitive impairment in clinical care: a survey of American Academy of Neurology members. Neurology. 2010 Aug 3;75(5):425-31. doi: 10.1212/WNL.0b013e3181eb5872.'}, {'pmid': '21696382', 'type': 'BACKGROUND', 'citation': "Roberts JS, Christensen KD, Green RC. Using Alzheimer's disease as a model for genetic risk disclosure: implications for personal genomics. Clin Genet. 2011 Nov;80(5):407-14. doi: 10.1111/j.1399-0004.2011.01739.x. Epub 2011 Jul 18."}, {'pmid': '29203084', 'type': 'RESULT', 'citation': "Guan Y, Roter DL, Wolff JL, Gitlin LN, Christensen KD, Roberts JS, Green RC, Erby LH. The impact of genetic counselors' use of facilitative strategies on cognitive and emotional processing of genetic risk disclosure for Alzheimer's disease. Patient Educ Couns. 2018 May;101(5):817-823. doi: 10.1016/j.pec.2017.11.019. Epub 2017 Nov 27."}, {'pmid': '28012682', 'type': 'RESULT', 'citation': "Guan Y, Roter DL, Erby LH, Wolff JL, Gitlin LN, Roberts JS, Green RC, Christensen KD. Disclosing genetic risk of Alzheimer's disease to cognitively impaired patients and visit companions: Findings from the REVEAL Study. Patient Educ Couns. 2017 May;100(5):927-935. doi: 10.1016/j.pec.2016.12.005. Epub 2016 Dec 14."}], 'seeAlsoLinks': [{'url': 'https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment', 'label': "Alzheimer's Association - Educational Materials on Mild Cognitive Impairment"}, {'url': 'http://www.alz.org/alzheimers_disease_causes_risk_factors.asp', 'label': "Alzheimer's Association - Educational Materials on Risk Factors"}, {'url': 'http://www.genomes2people.org/research/reveal/', 'label': 'REVEAL Study overview'}]}, 'descriptionModule': {'briefSummary': "This study is intended to examine the impact of receiving a genetic risk assessment for Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).", 'detailedDescription': "Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene which can provide information about a person's chances of developing Alzheimer's disease.\n\nSome people with a diagnosis of Mild Cognitive Impairment (MCI) are curious to learn more about the chance of developing Alzheimer's disease. In the REVEAL IV Study, we are examining the psychological and behavioral impact of learning genetic risk information pertaining to the chance for an individual with MCI to progress to dementia of the Alzheimer's type within three years.\n\nParticipation in this study requires an initial phone call which will elicit some demographic information about the participant and his or her study partner. A first in-person visit to the research clinic will consist of an education session, the administration of knowledge and attitudinal surveys and some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Participants with MCI will have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the intervention arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age, the diagnosis of MCI and their own APOE gene test result. Those in the comparison arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age and the diagnosis of MCI, without the APOE gene test result. Participants randomized to the comparison arm will have the opportunity to learn their own APOE gene test result at the end of the study. Participants and their study partners will be followed for 6 months following disclosure of results with 1 additional clinic visit and 1 additional phone interviews."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals (55-90 years old) with Mild Cognitive Impairment (amnestic-MCI as defined by the Petersen criteria)\n* Individuals who have a close friend, relative or spouse (18+) willing to be a study partner. Study partners attend each study visit with the participant and also complete surveys and interviews.\n\nExclusion Criteria:\n\n* Individuals with current, untreated anxiety or depression\n* Individuals who do not meet the criteria for amnestic-MCI\n* Individuals who have the diagnosis of dementia or Alzheimer's disease\n* Individuals not fluent in English\n* Individuals who do not have a study partner"}, 'identificationModule': {'nctId': 'NCT01434667', 'briefTitle': "Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV", 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': "Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV", 'orgStudyIdInfo': {'id': 'R01HG002213', 'link': 'https://reporter.nih.gov/quickSearch/R01HG002213', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HG002213', 'link': 'https://reporter.nih.gov/quickSearch/R01HG002213', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'APOE Genotype Non-Disclosure', 'description': "Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.", 'interventionNames': ["Behavioral: Alzheimer's disease risk disclosure"]}, {'type': 'EXPERIMENTAL', 'label': 'APOE Genotype Disclosure', 'description': "Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.", 'interventionNames': ["Behavioral: APOE genotype and Alzheimer's disease risk disclosure"]}], 'interventions': [{'name': "APOE genotype and Alzheimer's disease risk disclosure", 'type': 'BEHAVIORAL', 'description': "Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.", 'armGroupLabels': ['APOE Genotype Disclosure']}, {'name': "Alzheimer's disease risk disclosure", 'type': 'BEHAVIORAL', 'description': "Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.", 'armGroupLabels': ['APOE Genotype Non-Disclosure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Robert C Green, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital/Harvard Medical School"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Human Genome Research Institute (NHGRI)', 'class': 'NIH'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Howard University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, The REVEAL Study', 'investigatorFullName': 'Robert C. Green, MD, MPH', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}