Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-25 @ 4:13 PM
Study NCT ID:
NCT03335150
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cognitive Rehabilitation for PD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'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': 'Dawn.Schiehser@va.gov', 'phone': '858-552-8585', 'title': 'Dr. Dawn Schiehser', 'phoneExt': '2664', 'organization': 'VASDHS'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Clinical Motor Exam', 'notes': 'Subject was surprised when neurologist administered a standard clinical motor examination to assess balance (UPDRS). As required by the exam, neurologist firmly pulled back on shoulders. Subject reported X-rays with no results.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'OG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '2.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6662', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.4856', 'pValueComment': 'Interaction term', 'estimateComment': 'Estimated Value = Standard Error (SE) of the interaction term.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Equality'}, {'pValue': '0.1617', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2415', 'estimateComment': 'estimated value = SE', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mean Matrix Reasoning Total (MRT) difference between two visits while controlling for intervention.', 'nonInferiorityComment': 'Equality'}, {'pValue': '0.6236', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.5087', 'estimateComment': 'estimated value = SE', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mean MRT difference between two interventions while controlling for visit.', 'nonInferiorityComment': 'Equality'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 10', 'description': 'The WAIS-IV Matrix Reasoning test is a validated, objective measure of executive function. Scaled scores range from 0 to 26. Higher scores indicate better executive function. Scores reported below are change scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started and 2 dropped during group. Therefore, 50 completed measure.'}, {'type': 'SECONDARY', 'title': 'Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'OG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '3.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0496', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.58', 'pValueComment': 'Interaction term', 'estimateComment': 'Estimated value = SE of interaction term', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Equality'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 10', 'description': 'D-KEFS: 20 Questions Test measures executive function. The range of scores is 1 - 19 with a higher score representing better executive function. Scores reported below are change scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started and 2 dropped during group. Therefore, 50 completed measure.'}, {'type': 'SECONDARY', 'title': 'Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'OG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.51', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '-8.86', 'spread': '8.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.62', 'pValueComment': 'Interaction term', 'estimateComment': 'Estimated Value = SE of interaction term', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Equality'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 10', 'description': 'The measure examines self-reported change in cognition over time. Scores range from 16 - 80, with higher scores indicating worse functioning (or more cognitive decline). Scores reported below are change scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 1 was missing info. Therefore, 49 completed measure.'}, {'type': 'SECONDARY', 'title': 'Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'OG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.24', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '10.17', 'spread': '16.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.97', 'pValueComment': 'Interaction Term', 'estimateComment': 'Estimated Value = SE of interaction term', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Equality'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 10', 'description': 'CPSA measures cognitive problems and memory strategy use. The range for scores is 0 - 90, with higher scores indicating higher frequency of using memory and thinking strategies. Scores reported below are change scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 2 were missing info. Therefore, 48 completed measure.'}, {'type': 'SECONDARY', 'title': 'Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'OG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.49', 'spread': '7.03', 'groupId': 'OG000'}, {'value': '-10.46', 'spread': '12.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.25', 'pValueComment': 'Interaction term', 'estimateComment': 'Estimated Value = SE of interaction term', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Equality'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 10', 'description': 'IQCODE is a self-report questionnaire for caregivers that measures possible dementia and cognitive decline of the patient. The range for scores is 26 - 130, with higher score representing worse functioning/higher cognitive decline in the patient. Scores reported below are change scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group, 5 declined a caregiver, and 1 was missing info. 39 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, 2 were missing info, and 4 declined a caregiver. 44 completed measure.'}, {'type': 'SECONDARY', 'title': 'Memory for Intention Test (MIST) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'OG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '5.43', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '6.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.444', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.26', 'pValueComment': 'Interaction term', 'estimateComment': 'Estimated Value = SE of interaction term', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Equality'}, {'pValue': '0.0233', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.145', 'estimateComment': 'estimated value = SE', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'There is significant difference in MIST between intervention groups controlling for visit and other significant covariates.', 'nonInferiorityComment': 'Equality'}, {'pValue': '<0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.6281', 'estimateComment': 'estimated value = SE', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'There is significant difference in MIST between baseline and week 10 controlling for intervention group and other significant covariates', 'nonInferiorityComment': 'Equality'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 10', 'description': 'MIST measures prospective memory. The range for scores is 0 - 48 with a higher score representing better prospective memory. Scores reported below are change score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started and 2 dropped during group. Therefore, 50 completed measure.'}, {'type': 'SECONDARY', 'title': 'World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'OG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.02', 'spread': '11.60', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '9.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.205', 'pValueComment': 'Interaction term', 'estimateComment': 'estimated value = SE of interaction term', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Equality'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 10', 'description': 'WHOQOL-BREF is a self-reported measure of quality of life. Transformed score for the psychological domain ranges from 0 to 100. Higher scores indicate better quality of life. Scores reported below are change scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 1 was missing info. Therefore, 49 completed measure.'}, {'type': 'SECONDARY', 'title': "Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'OG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.31', 'spread': '11.56', 'groupId': 'OG000'}, {'value': '-2.69', 'spread': '10.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.25', 'pValueComment': 'Interaction Term', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Equality'}, {'pValue': '0.0257', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.1172', 'estimateComment': 'estimated value = SE', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mean PDQ-39 difference between baseline and week 10 controlling for intervention and covariates.', 'nonInferiorityComment': 'Equality'}, {'pValue': '0.1101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.8649', 'estimateComment': 'estimated value = SE', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Difference in PDQ-39 between two interventions controlling for visit and covariates.', 'nonInferiorityComment': 'Equality'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 10', 'description': "The PDQ-39 is a patient-reported measure of health and quality life over a 1-month period in individuals with Parkinson's disease. Total scores range from 0 to 156. Higher scores indicate poorer quality of life. Scores reported below are change scores.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group. Therefore, 45 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, and 1 was missing info. Therefore, 49 completed measure.'}, {'type': 'SECONDARY', 'title': 'Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'OG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'spread': '6.63', 'groupId': 'OG000'}, {'value': '-2.30', 'spread': '9.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0263', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.784', 'pValueComment': 'Interaction term', 'estimateComment': 'Estimated Value = SE of the interaction term.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Equality'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 10', 'description': 'The NPI-Q is a self-reported measure of neuropsychiatric symptoms over a 1 month period and 1 year period. Total month scores range from 0 to 156. Higher scores indicate greater severity of neuropsychiatric symptoms. Scores reported below are change scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 enrolled in Supportive Care: 6 dropped before group started, 1 dropped before baseline, 2 dropped during group, 5 declined a caregiver, and 2 were missing info. 38 completed measure. 55 were enrolled in CogSMART-PD: 3 dropped before group started, 2 dropped during group, 3 were missing info, and 4 declined a caregiver. 43 completed measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'FG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Enrolled + Assigned Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'PRE Testing Session', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Commenced Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'POST Testing Session', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Supportive Care', 'description': 'Support Group for PD\n\nSupportive Care: Support Group for persons with PD'}, {'id': 'BG001', 'title': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD\n\nCogSMART-PD: Cognitive Rehabilitation for persons with PD'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.59', 'spread': '7.06', 'groupId': 'BG000'}, {'value': '68.22', 'spread': '7.98', 'groupId': 'BG001'}, {'value': '69.39', 'spread': '7.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White or Caucasian', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.15', 'spread': '2.41', 'groupId': 'BG000'}, {'value': '15.8', 'spread': '2.29', 'groupId': 'BG001'}, {'value': '15.97', 'spread': '2.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The number of years participant received formal education', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69.02', 'spread': '55.97', 'groupId': 'BG000'}, {'value': '73.27', 'spread': '45.43', 'groupId': 'BG001'}, {'value': '71.18', 'spread': '50.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Time from Parkinson's disease diagnosis to enrollment", 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '54 subjects were enrolled for the Supportive Care group. 1 subject was missing the information.'}, {'title': 'Cognitive Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Normal Cognition', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Mild Cognitive Impairment', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cognitive status was determined using the Diagnostic Criteria for Mild Cognitive Impairment (Litvan et al., 2012).', 'unitOfMeasure': 'Participants', 'populationDescription': '55 subjects were enrolled into the CogSMART-PD group; however, 1 participant did not meet inclusion criteria.'}, {'title': 'Motor Symptoms', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.28', 'spread': '4.85', 'groupId': 'BG000'}, {'value': '11.76', 'spread': '3.73', 'groupId': 'BG001'}, {'value': '12.01', 'spread': '4.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Timed Up and Go (TUG) Test, a motor assessment', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '54 subjects were enrolled into the Supportive Care Group; however, 1 subject dropped before their baseline assessment, and 2 were unable to complete the measure in session. 55 subjects were enrolled into the CogSMART-PD group; however, 1 subject was unable to complete the measure in session.'}, {'title': 'Baseline Medication', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '685.26', 'spread': '445.71', 'groupId': 'BG000'}, {'value': '764.17', 'spread': '483.10', 'groupId': 'BG001'}, {'value': '725.09', 'spread': '464.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Amount of Levodopa Equivalent Dose (LED)', 'unitOfMeasure': 'milligrams', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "54 subjects enrolled in the Supportive Care group; however, 1 subject's medication info was missing. 55 subjects enrolled in the CogSMART-PD group; however, 1 subject dropped before their baseline assessment."}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-17', 'size': 565554, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-30T13:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigator and Assessor are blinded to group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2017-10-18', 'resultsFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-22', 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score', 'timeFrame': 'Baseline and Week 10', 'description': 'The WAIS-IV Matrix Reasoning test is a validated, objective measure of executive function. Scaled scores range from 0 to 26. Higher scores indicate better executive function. Scores reported below are change scores.'}], 'secondaryOutcomes': [{'measure': 'Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score', 'timeFrame': 'Baseline and Week 10', 'description': 'D-KEFS: 20 Questions Test measures executive function. The range of scores is 1 - 19 with a higher score representing better executive function. Scores reported below are change scores.'}, {'measure': 'Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score', 'timeFrame': 'Baseline and Week 10', 'description': 'The measure examines self-reported change in cognition over time. Scores range from 16 - 80, with higher scores indicating worse functioning (or more cognitive decline). Scores reported below are change scores.'}, {'measure': 'Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score', 'timeFrame': 'Baseline and Week 10', 'description': 'CPSA measures cognitive problems and memory strategy use. The range for scores is 0 - 90, with higher scores indicating higher frequency of using memory and thinking strategies. Scores reported below are change scores.'}, {'measure': 'Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score', 'timeFrame': 'Baseline and Week 10', 'description': 'IQCODE is a self-report questionnaire for caregivers that measures possible dementia and cognitive decline of the patient. The range for scores is 26 - 130, with higher score representing worse functioning/higher cognitive decline in the patient. Scores reported below are change scores.'}, {'measure': 'Memory for Intention Test (MIST) Total Score', 'timeFrame': 'Baseline and Week 10', 'description': 'MIST measures prospective memory. The range for scores is 0 - 48 with a higher score representing better prospective memory. Scores reported below are change score.'}, {'measure': 'World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score', 'timeFrame': 'Baseline and Week 10', 'description': 'WHOQOL-BREF is a self-reported measure of quality of life. Transformed score for the psychological domain ranges from 0 to 100. Higher scores indicate better quality of life. Scores reported below are change scores.'}, {'measure': "Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score", 'timeFrame': 'Baseline and Week 10', 'description': "The PDQ-39 is a patient-reported measure of health and quality life over a 1-month period in individuals with Parkinson's disease. Total scores range from 0 to 156. Higher scores indicate poorer quality of life. Scores reported below are change scores."}, {'measure': 'Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score', 'timeFrame': 'Baseline and Week 10', 'description': 'The NPI-Q is a self-reported measure of neuropsychiatric symptoms over a 1 month period and 1 year period. Total month scores range from 0 to 156. Higher scores indicate greater severity of neuropsychiatric symptoms. Scores reported below are change scores.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Rehabilitation', 'Cognition'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI).", 'detailedDescription': "Eligible study participants will be randomly assigned to one of two interventions: 1) Cognitive Rehabilitation (Cognitive Symptom Management and Rehabilitation Therapy for Parkinson's disease; CogSMART-PD) or 2) Supportive Care. Interventions are held within a group format consisting of approximately 5 individuals with PD. Groups will meet once per week for 1.5 hours over a 10-week period. Neuropsychological testing will be administered pre- and post-intervention as well as 6- and 12-months after the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of Parkinson's disease\n2. Mild Cognitive Impairment\n3. Over 40 years of age\n4. Fluent English speaker\n\nExclusion Criteria:\n\nOther neurological conditions (e.g., stroke) besides Parkinson's disease"}, 'identificationModule': {'nctId': 'NCT03335150', 'acronym': 'CogSMART-PD', 'briefTitle': 'Cognitive Rehabilitation for PD', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': "Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI", 'orgStudyIdInfo': {'id': 'E1691-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supportive Care', 'description': 'Support Group for PD-MCI', 'interventionNames': ['Behavioral: Supportive Care']}, {'type': 'EXPERIMENTAL', 'label': 'CogSMART-PD', 'description': 'Cognitive Rehabilitation for PD-MCI', 'interventionNames': ['Behavioral: CogSMART-PD']}], 'interventions': [{'name': 'CogSMART-PD', 'type': 'BEHAVIORAL', 'description': 'Cognitive Rehabilitation for persons with PD-MCI', 'armGroupLabels': ['CogSMART-PD']}, {'name': 'Supportive Care', 'type': 'BEHAVIORAL', 'description': 'Support Group for persons with PD-MCI', 'armGroupLabels': ['Supportive Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego, CA', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Dawn M. Schiehser, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA San Diego Healthcare System, San Diego, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}