Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00298558
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2006-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stennstedt@neriscience.com', 'phone': '617-972-3362', 'title': 'Sharon L. Tennstedt, PhD', 'organization': 'New England Research Institutes'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.', 'otherNumAtRisk': 711, 'otherNumAffected': 0, 'seriousNumAtRisk': 711, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.', 'otherNumAtRisk': 705, 'otherNumAffected': 0, 'seriousNumAtRisk': 705, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.', 'otherNumAtRisk': 712, 'otherNumAffected': 0, 'seriousNumAtRisk': 712, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control', 'description': 'This group did not complete any cognitive training interventions', 'otherNumAtRisk': 704, 'otherNumAffected': 0, 'seriousNumAtRisk': 704, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Cognitive Abilities of Memory From Baseline to Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}, {'value': '216', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.'}, {'id': 'OG001', 'title': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.'}, {'id': 'OG002', 'title': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group did not complete any cognitive training interventions'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.6', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '-11.2', 'spread': '26.3', 'groupId': 'OG001'}, {'value': '-12.7', 'spread': '25.5', 'groupId': 'OG002'}, {'value': '-9.4', 'spread': '29.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.06', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.27', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '0.17', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.11', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.10', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '0.52', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.05', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.15', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 years', 'description': 'Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the randomized subjects, 943 subjects who had the memory outcome at year 10 were used.'}, {'type': 'SECONDARY', 'title': 'Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use', 'timeFrame': '10th Year', 'description': 'To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Examine Health, Genetic and Cognitive Moderators', 'timeFrame': '10th Year', 'description': 'To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Cognitive Abilities of Reasoning From Baseline to Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}, {'value': '214', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.'}, {'id': 'OG001', 'title': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.'}, {'id': 'OG002', 'title': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group did not complete any cognitive training interventions'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.23', 'spread': '8.61', 'groupId': 'OG000'}, {'value': '-0.049', 'spread': '7.91', 'groupId': 'OG001'}, {'value': '-3.94', 'spread': '8.34', 'groupId': 'OG002'}, {'value': '-3.04', 'spread': '8.02', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.02', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.12', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.23', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.38', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '0.27', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.06', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.08', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 years', 'description': 'Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the randomized subjects, 938 subjects who had the reasoning outcome at year 10 were used.'}, {'type': 'SECONDARY', 'title': 'Estimate the Effects of ACTIVE Training to General Population', 'timeFrame': '10th Year', 'description': 'To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study(and its subsidiary studies), a population-based, nationally-representative cohort.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '203', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.'}, {'id': 'OG001', 'title': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.'}, {'id': 'OG002', 'title': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group did not complete any cognitive training interventions'}], 'classes': [{'categories': [{'measurements': [{'value': '-144.4', 'spread': '228.6', 'groupId': 'OG000'}, {'value': '-126.2', 'spread': '253.6', 'groupId': 'OG001'}, {'value': '24.3', 'spread': '252.1', 'groupId': 'OG002'}, {'value': '-123.3', 'spread': '277.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.07', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.16', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '0.95', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.005', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.23', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.66', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.88', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 years', 'description': 'Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the randomized subjects, 879 subjects who had the speed outcome at year 10 were used.'}, {'type': 'PRIMARY', 'title': 'Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '316', 'groupId': 'OG002'}, {'value': '284', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.'}, {'id': 'OG001', 'title': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.'}, {'id': 'OG002', 'title': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group did not complete any cognitive training interventions'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.05', 'spread': '7.38', 'groupId': 'OG000'}, {'value': '-2.66', 'spread': '6.31', 'groupId': 'OG001'}, {'value': '-2.34', 'spread': '5.62', 'groupId': 'OG002'}, {'value': '-3.61', 'spread': '7.67', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.48', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.84', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.38', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.74', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.36', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.72', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 years', 'description': 'The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the randomized subjects, 1211 subjects who had the IADL outcome at year 10 were used.'}, {'type': 'PRIMARY', 'title': 'Changes in Everyday Problem Solving From Baseline to Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}, {'value': '249', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.'}, {'id': 'OG001', 'title': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.'}, {'id': 'OG002', 'title': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group did not complete any cognitive training interventions'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.10', 'spread': '9.75', 'groupId': 'OG000'}, {'value': '-5.58', 'spread': '9.56', 'groupId': 'OG001'}, {'value': '-5.98', 'spread': '9.32', 'groupId': 'OG002'}, {'value': '-5.67', 'spread': '9.85', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.004', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.24', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '0.86', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.02', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.22', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '0.93', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.008', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.24', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 years', 'description': 'Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the randomized subjects, 1104 subjects who had the everyday problem solving outcome at year 10 were used.'}, {'type': 'PRIMARY', 'title': 'Changes in Everyday Speed of Processing From Baseline to Year 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '245', 'groupId': 'OG002'}, {'value': '215', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.'}, {'id': 'OG001', 'title': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.'}, {'id': 'OG002', 'title': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.'}, {'id': 'OG003', 'title': 'Control', 'description': 'This group did not complete any cognitive training interventions'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.53', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '1.88', 'groupId': 'OG001'}, {'value': '-1.47', 'spread': '1.98', 'groupId': 'OG002'}, {'value': '-1.42', 'spread': '1.78', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '0.02', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.23', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '0.96', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.004', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.21', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}, {'pValue': '0.56', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Effect Size', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.05', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.16', 'estimateComment': 'Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.', 'groupDescription': 'Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 years', 'description': 'Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the randomized subjects, 938 subjects who had the everyday speed of processing outcome at year 10 were used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.'}, {'id': 'FG001', 'title': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.'}, {'id': 'FG002', 'title': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.'}, {'id': 'FG003', 'title': 'Control', 'description': 'This group did not complete any cognitive training interventions'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '711'}, {'groupId': 'FG001', 'numSubjects': '705'}, {'groupId': 'FG002', 'numSubjects': '712'}, {'groupId': 'FG003', 'numSubjects': '704'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '711'}, {'groupId': 'FG001', 'numSubjects': '705'}, {'groupId': 'FG002', 'numSubjects': '712'}, {'groupId': 'FG003', 'numSubjects': '704'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '711'}, {'groupId': 'FG001', 'numSubjects': '705'}, {'groupId': 'FG002', 'numSubjects': '712'}, {'groupId': 'FG003', 'numSubjects': '704'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '620'}, {'groupId': 'FG001', 'numSubjects': '627'}, {'groupId': 'FG002', 'numSubjects': '637'}, {'groupId': 'FG003', 'numSubjects': '285'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '419'}]}]}, {'title': 'Immediate Post Test', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '711'}, {'groupId': 'FG001', 'numSubjects': '705'}, {'groupId': 'FG002', 'numSubjects': '712'}, {'groupId': 'FG003', 'numSubjects': '704'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '640'}, {'groupId': 'FG001', 'numSubjects': '629'}, {'groupId': 'FG002', 'numSubjects': '653'}, {'groupId': 'FG003', 'numSubjects': '639'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '65'}]}]}, {'title': 'Booster', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '372'}, {'groupId': 'FG001', 'numSubjects': '371'}, {'groupId': 'FG002', 'numSubjects': '370'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '301'}, {'groupId': 'FG002', 'numSubjects': '295'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '1st Annual (A1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '640'}, {'groupId': 'FG001', 'numSubjects': '629'}, {'groupId': 'FG002', 'numSubjects': '653'}, {'groupId': 'FG003', 'numSubjects': '639'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '585'}, {'groupId': 'FG001', 'numSubjects': '566'}, {'groupId': 'FG002', 'numSubjects': '601'}, {'groupId': 'FG003', 'numSubjects': '584'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '55'}]}]}, {'title': '2nd Annual (A2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '585'}, {'groupId': 'FG001', 'numSubjects': '566'}, {'groupId': 'FG002', 'numSubjects': '601'}, {'groupId': 'FG003', 'numSubjects': '584'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '563'}, {'groupId': 'FG001', 'numSubjects': '555'}, {'groupId': 'FG002', 'numSubjects': '574'}, {'groupId': 'FG003', 'numSubjects': '552'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '32'}]}]}, {'title': '3rd Annual Booster', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '372'}, {'groupId': 'FG001', 'numSubjects': '371'}, {'groupId': 'FG002', 'numSubjects': '370'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '243'}, {'groupId': 'FG002', 'numSubjects': '230'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '140'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '3rd Annual (A3) and 5th Annual (A5)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '563'}, {'groupId': 'FG001', 'numSubjects': '555'}, {'groupId': 'FG002', 'numSubjects': '574'}, {'groupId': 'FG003', 'numSubjects': '552'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '472'}, {'groupId': 'FG001', 'numSubjects': '469'}, {'groupId': 'FG002', 'numSubjects': '490'}, {'groupId': 'FG003', 'numSubjects': '448'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '104'}]}]}, {'title': '10th Annual (A10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '472'}, {'groupId': 'FG001', 'numSubjects': '469'}, {'groupId': 'FG002', 'numSubjects': '490'}, {'groupId': 'FG003', 'numSubjects': '448'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '316'}, {'groupId': 'FG002', 'numSubjects': '319'}, {'groupId': 'FG003', 'numSubjects': '285'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '171'}, {'groupId': 'FG003', 'numSubjects': '163'}]}]}], 'recruitmentDetails': 'Recruitment occurred from March 1998 through October 1999 at six metropolitan field centers: University of Alabama at Birmingham, Boston Hebrew Rehabilitation Center for Aged (now Hebrew Senior Life), Indiana University School of Medicine, Johns Hopkins University, Pennsylvania State University, and Wayne State University.', 'preAssignmentDetails': 'Eligibility and demographics were gathered at telephone screening.Health history, physical status, functional status, mental status, cognitive and function measures were gathered via in-person exams in individual and small-group formats at baseline.Eligible subjects were randomly assigned to one of three interventions or no-contact control group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '702', 'groupId': 'BG002'}, {'value': '698', 'groupId': 'BG003'}, {'value': '2802', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.'}, {'id': 'BG001', 'title': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.'}, {'id': 'BG002', 'title': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.'}, {'id': 'BG003', 'title': 'Control', 'description': 'This group did not complete any cognitive training interventions'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '702', 'groupId': 'BG002'}, {'value': '698', 'groupId': 'BG003'}, {'value': '2802', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'spread': '6.02', 'groupId': 'BG000'}, {'value': '73.5', 'spread': '5.76', 'groupId': 'BG001'}, {'value': '73.4', 'spread': '5.78', 'groupId': 'BG002'}, {'value': '74.0', 'spread': '6.05', 'groupId': 'BG003'}, {'value': '73.6', 'spread': '5.91', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '537', 'groupId': 'BG000'}, {'value': '537', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}, {'value': '514', 'groupId': 'BG003'}, {'value': '2126', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}, {'value': '676', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '703', 'groupId': 'BG000'}, {'value': '699', 'groupId': 'BG001'}, {'value': '702', 'groupId': 'BG002'}, {'value': '698', 'groupId': 'BG003'}, {'value': '2802', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Of 2832 randomized subjects, 30 subjects were randomized inappropriately in violation of the protocol and excluded from the analysis. Therefore, 2802 subjects were used for the baseline analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2832}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-24', 'studyFirstSubmitDate': '2006-02-28', 'resultsFirstSubmitDate': '2013-04-24', 'studyFirstSubmitQcDate': '2006-02-28', 'lastUpdatePostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-02', 'studyFirstPostDateStruct': {'date': '2006-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Cognitive Abilities of Memory From Baseline to Year 10', 'timeFrame': 'Up to 10 years', 'description': 'Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.'}, {'measure': 'Changes in Cognitive Abilities of Reasoning From Baseline to Year 10', 'timeFrame': 'Up to 10 years', 'description': 'Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.'}, {'measure': 'Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10', 'timeFrame': 'Up to 10 years', 'description': 'Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.'}, {'measure': 'Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10', 'timeFrame': 'Up to 10 years', 'description': 'The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.'}, {'measure': 'Changes in Everyday Problem Solving From Baseline to Year 10', 'timeFrame': 'Up to 10 years', 'description': 'Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.'}, {'measure': 'Changes in Everyday Speed of Processing From Baseline to Year 10', 'timeFrame': 'Up to 10 years', 'description': 'Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.'}], 'secondaryOutcomes': [{'measure': 'Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use', 'timeFrame': '10th Year', 'description': 'To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.'}, {'measure': 'Examine Health, Genetic and Cognitive Moderators', 'timeFrame': '10th Year', 'description': 'To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.'}, {'measure': 'Estimate the Effects of ACTIVE Training to General Population', 'timeFrame': '10th Year', 'description': 'To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study(and its subsidiary studies), a population-based, nationally-representative cohort.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cognition disorder', 'cognitive behavior therapy', 'functional ability'], 'conditions': ['Aging', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '11514044', 'type': 'BACKGROUND', 'citation': 'Jobe JB, Smith DM, Ball K, Tennstedt SL, Marsiske M, Willis SL, Rebok GW, Morris JN, Helmers KF, Leveck MD, Kleinman K. ACTIVE: a cognitive intervention trial to promote independence in older adults. Control Clin Trials. 2001 Aug;22(4):453-79. doi: 10.1016/s0197-2456(01)00139-8.'}, {'pmid': '16036723', 'type': 'BACKGROUND', 'citation': 'Jones RN, Rosenberg AL, Morris JN, Allaire JC, McCoy KJ, Marsiske M, Kleinman KP, Rebok GW, Malloy PF. A growth curve model of learning acquisition among cognitively normal older adults. Exp Aging Res. 2005 Jul-Sep;31(3):291-312. doi: 10.1080/03610730590948195.'}, {'pmid': '16420204', 'type': 'BACKGROUND', 'citation': 'Kuo HK, Jones RN, Milberg WP, Tennstedt S, Talbot L, Morris JN, Lipsitz LA. Cognitive function in normal-weight, overweight, and obese older adults: an analysis of the Advanced Cognitive Training for Independent and Vital Elderly cohort. J Am Geriatr Soc. 2006 Jan;54(1):97-103. doi: 10.1111/j.1532-5415.2005.00522.x.'}, {'pmid': '18160968', 'type': 'BACKGROUND', 'citation': 'Diehl M, Marsiske M, Horgas AL, Rosenberg A, Saczynski JS, Willis SL. The Revised Observed Tasks of Daily Living: A Performance-Based Assessment of Everyday Problem Solving in Older Adults. J Appl Gerontol. 2005;24(3):211-230. doi: 10.1177/0733464804273772.'}, {'pmid': '17661957', 'type': 'BACKGROUND', 'citation': 'Wadley VG, Crowe M, Marsiske M, Cook SE, Unverzagt FW, Rosenberg AL, Rexroth D. Changes in everyday function in individuals with psychometrically defined mild cognitive impairment in the Advanced Cognitive Training for Independent and Vital Elderly Study. J Am Geriatr Soc. 2007 Aug;55(8):1192-8. doi: 10.1111/j.1532-5415.2007.01245.x.'}, {'pmid': '23095218', 'type': 'BACKGROUND', 'citation': 'Cook SE, Marsiske M, Thomas KR, Unverzagt FW, Wadley VG, Langbaum JB, Crowe M. Identification of mild cognitive impairment in ACTIVE: algorithmic classification and stability. J Int Neuropsychol Soc. 2013 Jan;19(1):73-87. doi: 10.1017/S1355617712000938. Epub 2012 Oct 25.'}, {'pmid': '12053117', 'type': 'BACKGROUND', 'citation': 'Owsley C, Sloane M, McGwin G Jr, Ball K. Timed instrumental activities of daily living tasks: relationship to cognitive function and everyday performance assessments in older adults. Gerontology. 2002 Jul-Aug;48(4):254-65. doi: 10.1159/000058360.'}, {'pmid': '14578009', 'type': 'BACKGROUND', 'citation': 'Gallo JJ, Rebok GW, Tennsted S, Wadley VG, Horgas A; Advanced Cognitive Training for Independent and Vital Elderly (Active) Study Investigators. Linking depressive symptoms and functional disability in late life. Aging Ment Health. 2003 Nov;7(6):469-80. doi: 10.1080/13607860310001594736.'}, {'pmid': '15075414', 'type': 'BACKGROUND', 'citation': 'Caskie GI, Willis SL. Congruence of self-reported medications with pharmacy prescription records in low-income older adults. Gerontologist. 2004 Apr;44(2):176-85. doi: 10.1093/geront/44.2.176.'}, {'pmid': '16704918', 'type': 'BACKGROUND', 'citation': 'Edwards JD, Ross LA, Wadley VG, Clay OJ, Crowe M, Roenker DL, Ball KK. The useful field of view test: normative data for older adults. Arch Clin Neuropsychol. 2006 May;21(4):275-86. doi: 10.1016/j.acn.2006.03.001. Epub 2006 May 15.'}, {'pmid': '16960242', 'type': 'BACKGROUND', 'citation': 'Wolinsky FD, Unverzagt FW, Smith DM, Jones R, Wright E, Tennstedt SL. The effects of the ACTIVE cognitive training trial on clinically relevant declines in health-related quality of life. J Gerontol B Psychol Sci Soc Sci. 2006 Sep;61(5):S281-7. doi: 10.1093/geronb/61.5.s281.'}, {'pmid': '16955448', 'type': 'BACKGROUND', 'citation': 'Crowe M, Andel R, Wadley V, Cook S, Unverzagt F, Marsiske M, Ball K. Subjective cognitive function and decline among older adults with psychometrically defined amnestic MCI. Int J Geriatr Psychiatry. 2006 Dec;21(12):1187-92. doi: 10.1002/gps.1639.'}, {'pmid': '16108933', 'type': 'BACKGROUND', 'citation': 'Kuo HK, Jones RN, Milberg WP, Tennstedt S, Talbot L, Morris JN, Lipsitz LA. Effect of blood pressure and diabetes mellitus on cognitive and physical functions in older adults: a longitudinal analysis of the advanced cognitive training for independent and vital elderly cohort. J Am Geriatr Soc. 2005 Jul;53(7):1154-61. doi: 10.1111/j.1532-5415.2005.53368.x.'}, {'pmid': '17234829', 'type': 'BACKGROUND', 'citation': 'Wolinsky FD, Unverzagt FW, Smith DM, Jones R, Stoddard A, Tennstedt SL. The ACTIVE cognitive training trial and health-related quality of life: protection that lasts for 5 years. J Gerontol A Biol Sci Med Sci. 2006 Dec;61(12):1324-9. doi: 10.1093/gerona/61.12.1324.'}, {'pmid': '17565162', 'type': 'BACKGROUND', 'citation': 'Ball K, Edwards JD, Ross LA. The impact of speed of processing training on cognitive and everyday functions. J Gerontol B Psychol Sci Soc Sci. 2007 Jun;62 Spec No 1:19-31. doi: 10.1093/geronb/62.special_issue_1.19.'}, {'pmid': '17565165', 'type': 'BACKGROUND', 'citation': 'Rebok GW, Carlson MC, Langbaum JB. Training and maintaining memory abilities in healthy older adults: traditional and novel approaches. J Gerontol B Psychol Sci Soc Sci. 2007 Jun;62 Spec No 1:53-61. doi: 10.1093/geronb/62.special_issue_1.53.'}, {'pmid': '17942013', 'type': 'BACKGROUND', 'citation': 'Unverzagt FW, Kasten L, Johnson KE, Rebok GW, Marsiske M, Koepke KM, Elias JW, Morris JN, Willis SL, Ball K, Rexroth DF, Smith DM, Wolinsky FD, Tennstedt SL. Effect of memory impairment on training outcomes in ACTIVE. J Int Neuropsychol Soc. 2007 Nov;13(6):953-60. doi: 10.1017/S1355617707071512.'}, {'pmid': '18332196', 'type': 'BACKGROUND', 'citation': 'Edwards JD, Ross LA, Ackerman ML, Small BJ, Ball KK, Bradley S, Dodson JE. Longitudinal predictors of driving cessation among older adults from the ACTIVE clinical trial. J Gerontol B Psychol Sci Soc Sci. 2008 Jan;63(1):P6-12. doi: 10.1093/geronb/63.1.p6.'}, {'pmid': '18189169', 'type': 'BACKGROUND', 'citation': 'Morgan AA, Marsiske M, Whitfield KE. Characterizing and explaining differences in cognitive test performance between african american and European American older adults. Exp Aging Res. 2008 Jan-Mar;34(1):80-100. doi: 10.1080/03610730701776427.'}, {'pmid': '20216922', 'type': 'BACKGROUND', 'citation': 'Vance DE, Ross LA, Crowe MG, Wadley VG, Edwards JD, Ball KK. THE RELATIONSHIP OF MEMORY, REASONING, AND SPEED OF PROCESSING ON FALLING AMONG OLDER ADULTS. Phys Occup Ther Geriatr. 2008;27(3):212-228. doi: 10.1080/02703180802377123.'}, {'pmid': '19139253', 'type': 'BACKGROUND', 'citation': 'Ackerman ML, Edwards JD, Ross LA, Ball KK, Lunsman M. Examination of cognitive and instrumental functional performance as indicators for driving cessation risk across 3 years. Gerontologist. 2008 Dec;48(6):802-10. doi: 10.1093/geront/48.6.802.'}, {'pmid': '19196693', 'type': 'BACKGROUND', 'citation': 'Langbaum JB, Rebok GW, Bandeen-Roche K, Carlson MC. Predicting memory training response patterns: results from ACTIVE. J Gerontol B Psychol Sci Soc Sci. 2009 Jan;64(1):14-23. doi: 10.1093/geronb/gbn026. Epub 2009 Feb 4.'}, {'pmid': '19271829', 'type': 'BACKGROUND', 'citation': 'Tucker-Drob EM, Johnson KE, Jones RN. The cognitive reserve hypothesis: a longitudinal examination of age-associated declines in reasoning and processing speed. Dev Psychol. 2009 Mar;45(2):431-46. doi: 10.1037/a0014012.'}, {'pmid': '19196692', 'type': 'BACKGROUND', 'citation': 'Ross LA, Clay OJ, Edwards JD, Ball KK, Wadley VG, Vance DE, Cissell GM, Roenker DL, Joyce JJ. Do older drivers at-risk for crashes modify their driving over time? J Gerontol B Psychol Sci Soc Sci. 2009 Mar;64(2):163-70. doi: 10.1093/geronb/gbn034. Epub 2009 Feb 4.'}, {'pmid': '19181719', 'type': 'BACKGROUND', 'citation': 'Wolinsky FD, Vander Weg MW, Martin R, Unverzagt FW, Ball KK, Jones RN, Tennstedt SL. The effect of speed-of-processing training on depressive symptoms in ACTIVE. J Gerontol A Biol Sci Med Sci. 2009 Apr;64(4):468-72. doi: 10.1093/gerona/gln044. Epub 2009 Jan 30.'}, {'pmid': '19558724', 'type': 'BACKGROUND', 'citation': 'Wolinsky FD, Mahncke HW, Kosinski M, Unverzagt FW, Smith DM, Jones RN, Stoddard A, Tennstedt SL. The ACTIVE cognitive training trial and predicted medical expenditures. BMC Health Serv Res. 2009 Jun 29;9:109. doi: 10.1186/1472-6963-9-109.'}, {'pmid': '19689237', 'type': 'BACKGROUND', 'citation': "Unverzagt FW, Smith DM, Rebok GW, Marsiske M, Morris JN, Jones R, Willis SL, Ball K, King JW, Koepke KM, Stoddard A, Tennstedt SL. The Indiana Alzheimer Disease Center's Symposium on Mild Cognitive Impairment. Cognitive training in older adults: lessons from the ACTIVE Study. Curr Alzheimer Res. 2009 Aug;6(4):375-83. doi: 10.2174/156720509788929345."}, {'pmid': '19617456', 'type': 'BACKGROUND', 'citation': 'Wolinsky FD, Mahncke HW, Weg MW, Martin R, Unverzagt FW, Ball KK, Jones RN, Tennstedt SL. The ACTIVE cognitive training interventions and the onset of and recovery from suspected clinical depression. J Gerontol B Psychol Sci Soc Sci. 2009 Sep;64(5):577-85. doi: 10.1093/geronb/gbp061. Epub 2009 Jul 17.'}, {'pmid': '19675177', 'type': 'BACKGROUND', 'citation': 'Edwards JD, Lunsman M, Perkins M, Rebok GW, Roth DL. Driving cessation and health trajectories in older adults. J Gerontol A Biol Sci Med Sci. 2009 Dec;64(12):1290-5. doi: 10.1093/gerona/glp114. Epub 2009 Aug 12.'}, {'pmid': '19726665', 'type': 'BACKGROUND', 'citation': 'Edwards JD, Delahunt PB, Mahncke HW. Cognitive speed of processing training delays driving cessation. J Gerontol A Biol Sci Med Sci. 2009 Dec;64(12):1262-7. doi: 10.1093/gerona/glp131. Epub 2009 Sep 2.'}, {'pmid': '19709169', 'type': 'BACKGROUND', 'citation': 'Kvale EA, Clay OJ, Ross-Meadows LA, McGee JS, Edwards JD, Unverzagt FW, Ritchie CS, Ball KK. Cognitive speed of processing and functional declines in older cancer survivors: an analysis of data from the ACTIVE trial. Eur J Cancer Care (Engl). 2010 Jan 1;19(1):110-7. doi: 10.1111/j.1365-2354.2008.01018.x. Epub 2009 Aug 26.'}, {'pmid': '20003628', 'type': 'BACKGROUND', 'citation': 'Wolinsky FD, Mahncke H, Vander Weg MW, Martin R, Unverzagt FW, Ball KK, Jones RN, Tennstedt SL. Speed of processing training protects self-rated health in older adults: enduring effects observed in the multi-site ACTIVE randomized controlled trial. Int Psychogeriatr. 2010 May;22(3):470-8. doi: 10.1017/S1041610209991281. Epub 2009 Dec 15.'}, {'pmid': '20147739', 'type': 'BACKGROUND', 'citation': "O'Connor ML, Edwards JD, Wadley VG, Crowe M. Changes in mobility among older adults with psychometrically defined mild cognitive impairment. J Gerontol B Psychol Sci Soc Sci. 2010 May;65B(3):306-16. doi: 10.1093/geronb/gbq003. Epub 2010 Feb 10."}, {'pmid': '20808123', 'type': 'BACKGROUND', 'citation': 'Yen YC, Rebok GW, Gallo JJ, Jones RN, Tennstedt SL. Depressive symptoms impair everyday problem-solving ability through cognitive abilities in late life. Am J Geriatr Psychiatry. 2011 Feb;19(2):142-50. doi: 10.1097/JGP.0b013e3181e89894.'}, {'pmid': '20008028', 'type': 'BACKGROUND', 'citation': 'Wolinsky FD, Vander Weg MW, Martin R, Unverzagt FW, Willis SL, Marsiske M, Rebok GW, Morris JN, Ball KK, Tennstedt SL. Does cognitive training improve internal locus of control among older adults? J Gerontol B Psychol Sci Soc Sci. 2010 Sep;65(5):591-8. doi: 10.1093/geronb/gbp117. Epub 2009 Dec 11.'}, {'pmid': '20845121', 'type': 'BACKGROUND', 'citation': 'Aiken Morgan AT, Marsiske M, Dzierzewski JM, Jones RN, Whitfield KE, Johnson KE, Cresci MK. Race-related cognitive test bias in the active study: a mimic model approach. Exp Aging Res. 2010 Oct;36(4):426-52. doi: 10.1080/0361073X.2010.507427.'}, {'pmid': '21069610', 'type': 'BACKGROUND', 'citation': 'Gross AL, Rebok GW, Unverzagt FW, Willis SL, Brandt J. Word list memory predicts everyday function and problem-solving in the elderly: results from the ACTIVE cognitive intervention trial. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2011 Mar;18(2):129-46. doi: 10.1080/13825585.2010.516814. Epub 2010 Nov 10.'}, {'pmid': '21054291', 'type': 'BACKGROUND', 'citation': 'Ball K, Edwards JD, Ross LA, McGwin G Jr. Cognitive training decreases motor vehicle collision involvement of older drivers. J Am Geriatr Soc. 2010 Nov;58(11):2107-13. doi: 10.1111/j.1532-5415.2010.03138.x.'}, {'pmid': '21463064', 'type': 'BACKGROUND', 'citation': 'Parisi JM, Gross AL, Rebok GW, Saczynski JS, Crowe M, Cook SE, Langbaum JB, Sartori A, Unverzagt FW. Modeling change in memory performance and memory perceptions: findings from the ACTIVE study. Psychol Aging. 2011 Sep;26(3):518-24. doi: 10.1037/a0022458.'}, {'pmid': '22138270', 'type': 'BACKGROUND', 'citation': "O'Connor ML, Edwards JD, Small BJ, Andel R. Patterns of level and change in self-reported driving behaviors among older adults: who self-regulates? J Gerontol B Psychol Sci Soc Sci. 2012 Jul;67(4):437-46. doi: 10.1093/geronb/gbr122. Epub 2011 Dec 1."}, {'pmid': '21443356', 'type': 'BACKGROUND', 'citation': 'Gross AL, Rebok GW. Memory training and strategy use in older adults: results from the ACTIVE study. Psychol Aging. 2011 Sep;26(3):503-17. doi: 10.1037/a0022687.'}, {'pmid': '21558167', 'type': 'BACKGROUND', 'citation': 'Gross AL, Rebok GW, Unverzagt FW, Willis SL, Brandt J. Cognitive predictors of everyday functioning in older adults: results from the ACTIVE Cognitive Intervention Trial. J Gerontol B Psychol Sci Soc Sci. 2011 Sep;66(5):557-66. doi: 10.1093/geronb/gbr033. 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Epub 2012 Oct 19.'}, {'pmid': '12425704', 'type': 'RESULT', 'citation': 'Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.'}, {'pmid': '17179457', 'type': 'RESULT', 'citation': 'Willis SL, Tennstedt SL, Marsiske M, Ball K, Elias J, Koepke KM, Morris JN, Rebok GW, Unverzagt FW, Stoddard AM, Wright E; ACTIVE Study Group. Long-term effects of cognitive training on everyday functional outcomes in older adults. JAMA. 2006 Dec 20;296(23):2805-14. doi: 10.1001/jama.296.23.2805.'}, {'pmid': '39520262', 'type': 'DERIVED', 'citation': 'Phillips CB, McVey A, Sprague BN, Cooper K, Stephan AT, Ross LA. Predictive Utility of Four Instrumental Activities of Daily Living Assessments and Cognitive Status Changes Among Cognitively In-Tact Older Adults. J Aging Health. 2025 Dec;37(10):683-693. doi: 10.1177/08982643241297193. Epub 2024 Nov 9.'}, {'pmid': '39360568', 'type': 'DERIVED', 'citation': 'Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.'}, {'pmid': '36981850', 'type': 'DERIVED', 'citation': 'Sprague BN, Ross LA, Ball KK. Does Cognitive Training Reduce Falls across Ten Years?: Data from the ACTIVE Trial. Int J Environ Res Public Health. 2023 Mar 11;20(6):4941. doi: 10.3390/ijerph20064941.'}, {'pmid': '35901382', 'type': 'DERIVED', 'citation': 'Bell TR, Sprague BN, Ross LA. Longitudinal associations of pain and cognitive decline in community-dwelling older adults. Psychol Aging. 2022 Sep;37(6):715-730. doi: 10.1037/pag0000699. Epub 2022 Jul 28.'}, {'pmid': '34329436', 'type': 'DERIVED', 'citation': 'Chamberlain JD, Sprague BN, Ross LA. Age- and Time-Varying Associations Between Subjective Health and Episodic Memory in Older Adults. J Gerontol B Psychol Sci Soc Sci. 2022 Apr 1;77(4):673-682. doi: 10.1093/geronb/gbab142.'}, {'pmid': '27804270', 'type': 'DERIVED', 'citation': 'Clark DO, Xu H, Callahan CM, Unverzagt FW. Does Body Mass Index Modify Memory, Reasoning, and Speed of Processing Training Effects in Older Adults. Obesity (Silver Spring). 2016 Nov;24(11):2319-2326. doi: 10.1002/oby.21631.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the ACTIVE study was to test if cognitive training interventions could maintain functional independence in elders by improving basic mental abilities, with follow-up assessments through five years.', 'detailedDescription': "ACTIVE was a 4-arm, single-blind, randomized controlled trial. The primary objective of ACTIVE was to test the effectiveness and durability of three distinct cognitive interventions in improving elders' performance on basic measures of cognition and measures of cognitively demanding daily activities (e.g., food preparation, driving, medication use, financial management). These interventions previously had been found successful in improving cognitive abilities under laboratory or small-scale field conditions.\n\nThe three interventions shared common design features: 1) equivalent intensity and duration; 2) small group settings in ten 60-75 minute sessions; 3) focus on strategies for solving problems, remembering, or responding quickly to information; 4) modeling and demonstration of strategy usage; 5) practice on exemplar problems; 6) individual and group exercises; 7) feedback on performance; 8) fostering of self-efficacy regarding performance; 9) applying strategies to real-world tasks; 10) individualized training experiences, and 11) social interaction activities. In all three interventions, Sessions 1-5 focused on strategy instruction and exercises to practice the strategy. Sessions 6-10 provided additional practice exercises, but no new strategies were introduced. Content for each of the 10 sessions was scripted in a trainer's manual.\n\nInterventions:\n\n1. Reasoning training focused on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning. Participants were taught strategies to identify the pattern or sequence required to solve a problem. Training exercises involved identifying patterns in both laboratory-type reasoning tasks and in everyday activities, e.g., understanding the pattern in a bus schedule.\n2. Memory training focused on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information. Training exercises involved recalling laboratory-like episodic memory tasks as well as tasks related to everyday activities such as recalling a shopping list.\n3. Speed training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format, with and without distractors. Participants practiced speeded tasks on a computer, and were allowed to proceed to more complex tasks, and faster and faster presentation speeds at their own pace.\n4. A control group received no training.\n\nIn addition, booster training was provided to help participants maintain gains made from initial training and to further improve cognitive skills. Booster training was provided to a random sample of approximately 50% of training participants at 11 and 35-36 months after primary training.\n\nParticipant involvement included assessments conducted at baseline, immediately post-intervention, and at 12, 24, 36 and 60 months. Assessments were conducted in individual and group sessions. For participants randomized to intervention groups, the interventions were conducted in small group settings in ten 60-75 minute sessions over a 5-6 week period. These were behavioral interventions with no pharmacologic component. Eleven months after the initial training was provided, booster training was offered, in all three intervention arms, to a randomly selected 60% of initially trained subjects. Booster training was delivered in four 75-minute sessions over a 2-3 week period.\n\nThe primary study hypotheses were:\n\n* Each training group will perform better than the other training and control groups on their respective primary and proximal outcomes\n* Those groups that received booster training will perform better than those that did not receive booster training on their respective primary and proximal outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 65 or older\n* Mini-Mental State Examination (MMSE) score 23 or greater\n* Vision scored greater than 20/50\n* Minimal dependence in hygiene, bathing, and dressing\n\nExclusion Criteria:\n\n* Significant decline in cognitive skills, physical abilities, or functional independence\n* Inability to complete study activities as evidenced by MMSE and vision scores lower than Inclusion Criteria requirement\n* Diagnosis of Alzheimer's disease\n* Stroke in previous 12 months\n* Cancer with limited life expectance\n* Current chemotherapy or radiation treatment\n* Communication problems\n* Planned move from study area\n* Scheduling conflicts that would preclude participation in study activities\n* Prior involvement in similar cognitive training studies"}, 'identificationModule': {'nctId': 'NCT00298558', 'acronym': 'ACTIVE', 'briefTitle': 'ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Carelon Research'}, 'officialTitle': 'Trial of a Cognitive Intervention for Older Adults', 'orgStudyIdInfo': {'id': 'IA0091'}, 'secondaryIdInfos': [{'id': 'U01NR004507', 'link': 'https://reporter.nih.gov/quickSearch/U01NR004507', 'type': 'NIH'}, {'id': 'U01NR004508', 'link': 'https://reporter.nih.gov/quickSearch/U01NR004508', 'type': 'NIH'}, {'id': 'U01AG014260', 'link': 'https://reporter.nih.gov/quickSearch/U01AG014260', 'type': 'NIH'}, {'id': 'U01AG014282', 'link': 'https://reporter.nih.gov/quickSearch/U01AG014282', 'type': 'NIH'}, {'id': 'U01AG014263', 'link': 'https://reporter.nih.gov/quickSearch/U01AG014263', 'type': 'NIH'}, {'id': 'U01AG014289', 'link': 'https://reporter.nih.gov/quickSearch/U01AG014289', 'type': 'NIH'}, {'id': 'U01AG014276', 'link': 'https://reporter.nih.gov/quickSearch/U01AG014276', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Memory Training', 'description': 'Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.', 'interventionNames': ['Behavioral: Cognitive Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reasoning Training', 'description': 'Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.', 'interventionNames': ['Behavioral: Cognitive Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Speed of Processing Training', 'description': 'Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.', 'interventionNames': ['Behavioral: Cognitive Training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'This group did not complete any cognitive training interventions', 'interventionNames': ['Behavioral: Cognitive Training']}], 'interventions': [{'name': 'Cognitive Training', 'type': 'BEHAVIORAL', 'description': 'Memory, Reasoning, or Speed of Processing cognitive training interventions', 'armGroupLabels': ['Control', 'Memory Training', 'Reasoning Training', 'Speed of Processing Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21205', 'city': 'Cumberland', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.65287, 'lon': -78.76252}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Hebrew Rehabilitation Center for the Aged', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'overallOfficials': [{'name': 'Karlene Ball, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Frederick Unverzagt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'George Rebok, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'John Morris, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebrew Senior Life'}, {'name': 'Sharon L. Tennstedt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carelon Research'}, {'name': 'Michael Marsiske, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}, {'name': 'Sherry Willis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carelon Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}