Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-04-10 @ 7:22 AM
Study NCT ID:
NCT03255967
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2017-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dementia Symptom Management at Home Program
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Abraham.Brody@nyulangone.org', 'phone': '2129927341', 'title': 'Abraham Brody', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '60 Days', 'description': 'The Data Safety and Monitoring Board required a focused adverse event (AE) collection process which requires following single AE: a PHQ-9 score worsened by greater than or equal to 5 points during the course of the study. The DSMB required monitoring the following severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical event that may jeopardize the subject, including hospitalization of either the person with dementia or caregiver, suicidal ideation.', 'eventGroups': [{'id': 'EG000', 'title': 'QI Program Care - PWD', 'description': 'Patients with dementia (PWD) assigned to the QI program care arm as part of a Patient-Caregiver dyad.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 21, 'seriousNumAtRisk': 119, 'deathsNumAffected': 6, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'QI Program Care - Caregiver', 'description': 'Caregivers assigned to the QI program care arm as part of a Patient-Caregiver dyad.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 5, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Control - PWD', 'description': 'Patients with dementia (PWD) assigned to the control arm as part of a Patient-Caregiver dyad.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 9, 'seriousNumAtRisk': 96, 'deathsNumAffected': 10, 'seriousNumAffected': 34}, {'id': 'EG003', 'title': 'Control - Caregiver', 'description': 'Caregivers assigned to the control arm as part of a Patient-Caregiver dyad.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 1, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Increase in symptoms of dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in pre-existing condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'New Diagnosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressive Symptoms (Score on PHQ-9)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury not life threatening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delirium False Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Caregiver severe depression (Increase Score on PHQ-9 [Day 60])', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Caregiver suicide idealization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 96, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change in Quality of Life-Alzheimer's Disease Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.32', 'spread': '16.69', 'groupId': 'OG000'}, {'value': '15.88', 'spread': '22.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': "13-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.32', 'spread': '16.69', 'groupId': 'OG000'}, {'value': '15.88', 'spread': '22.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the IADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with IADLs improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.45', 'spread': '37.45', 'groupId': 'OG000'}, {'value': '44.94', 'spread': '37.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the ADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with ADLs improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.33', 'spread': '28.96', 'groupId': 'OG000'}, {'value': '46.56', 'spread': '26.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the role limitations scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to role limitation due to caregiving improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.71', 'spread': '22.12', 'groupId': 'OG000'}, {'value': '40.34', 'spread': '19.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the personal time scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to personal care improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.27', 'spread': '28.45', 'groupId': 'OG000'}, {'value': '52.11', 'spread': '28.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the family interaction scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to family interaction improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '24.39', 'groupId': 'OG000'}, {'value': '56.22', 'spread': '25.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the demands of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to demands of caregiving improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.25', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '52.56', 'spread': '19.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the worry scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to worry improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.25', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '67.75', 'spread': '33.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the spirituality scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to spirituality improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.38', 'spread': '20.18', 'groupId': 'OG000'}, {'value': '79.34', 'spread': '20.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the benefits of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to benefits of caregiving improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.53', 'spread': '16.82', 'groupId': 'OG000'}, {'value': '76.49', 'spread': '13.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the caregiver feelings scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to caregiver feelings improved during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 60', 'description': 'Measured through interviews with the informal caregiver using the Resource Utilization Inventory.', 'unitOfMeasure': 'ER visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of PWD Inpatient Admissions During Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 60', 'description': 'Measured through interviews with the informal caregiver using the Resource Utilization Inventory.', 'unitOfMeasure': 'Hospitalizations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pain Assessment In Advanced Dementia (PAINAD) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': '5-item assessment of pain in individuals with advanced dementia. Items are ranked on a 3-point Likert scale from 0 to 2. The total score is the sum of responses and ranges from 0 (no pain) to 10 (severe pain). An increase in scores indicates pain increased during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.45', 'spread': '6.31', 'groupId': 'OG000'}, {'value': '7.96', 'spread': '5.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': '13-item tool that measures caregiver perceptions of Behavioral and Psychological Symptoms of Dementia (BPSD). For each item, The severity of the reported symptoms is assessed on a 3-point scale. The total severity score ranges from 0 to 36 with higher scores representing worse severity. An increase in score indicates severity of BPSD increased during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of PWD Who Use Antipsychotics During Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 60', 'description': 'Measured via patient medication record.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of PWD Who Use Analgesics During Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 60', 'description': 'Measured via patient medication record.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of PWD Outpatient Visits During Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '12.15', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '4.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 60', 'unitOfMeasure': 'Outpatient Visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of PWD Primary Care Provider Contacts During Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 60', 'unitOfMeasure': 'Primary Care Provider Contacts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Zarit Burden Inventory Score Among Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.65', 'spread': '16.21', 'groupId': 'OG000'}, {'value': '26.14', 'spread': '13.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': '22-item self-assessment of burden experienced by caregivers. Items are ranked on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 88, where: 0 - 21 = little or no burden; 21 - 40 = mild to moderate burden; 41 - 60 = moderate to severe burden; and 61 - 88 = severe burden. An increase in scores indicates burden increased during the observational period.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '5.03', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '4.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': '9-item measurement of depression in which caregivers indicate how often they have been bothered by specific problems over the previous 2 weeks. Items are ranked on 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater severity of depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.15', 'spread': '11.13', 'groupId': 'OG000'}, {'value': '47.13', 'spread': '11.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': '12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Physical Composite Scores (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'OG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.63', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '47.59', 'spread': '9.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 60', 'description': '12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Mental Health Composite Scores (MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QI Program Care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program\n\nDSM-H: Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC'}, {'id': 'FG001', 'title': 'Control', 'description': 'receive usual care from a care team who has not received the performance improvement program\n\nStandard of Care: Subjects receive care through usual home healthcare assignment process.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'Number of Patients Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'Number of Patients Completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Number of Caregivers Started', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'Number of Caregivers Completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Schedule conflict', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'POA did not sign consent form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The trial enrolled 215 Patient-Caregiver Dyads (215 patients with dementia (PWD) and 215 caregivers). 119 Dyads were randomized to the QI program care arm and 96 Dyads were randomized to the Control arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '430', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'QI Program Care - PWD', 'description': 'Patients with dementia (PWD) assigned to the QI program care arm as part of a Patient-Caregiver dyad.'}, {'id': 'BG001', 'title': 'QI Program Care - Caregiver', 'description': 'Caregivers assigned to the QI program care arm as part of a Patient-Caregiver dyad.'}, {'id': 'BG002', 'title': 'Control - PWD', 'description': 'Patients with dementia (PWD) assigned to the control arm as part of a Patient-Caregiver dyad.'}, {'id': 'BG003', 'title': 'Control - Caregiver', 'description': 'Caregivers assigned to the control arm as part of a Patient-Caregiver dyad.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '83', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '63', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '84', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '57', 'spread': '11.9', 'groupId': 'BG003'}, {'value': '71.75', 'spread': '7.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '302', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}, {'value': '375', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '124', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '271', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '430', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-27', 'size': 1928790, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-31T16:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-26', 'studyFirstSubmitDate': '2017-08-15', 'resultsFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2017-08-17', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-26', 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Quality of Life-Alzheimer's Disease Score", 'timeFrame': 'Baseline, Day 60', 'description': "13-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period."}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the IADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with IADLs improved during the observational period.'}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the ADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with ADLs improved during the observational period.'}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the role limitations scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to role limitation due to caregiving improved during the observational period.'}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the personal time scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to personal care improved during the observational period.'}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the family interaction scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to family interaction improved during the observational period.'}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the demands of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to demands of caregiving improved during the observational period.'}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the worry scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to worry improved during the observational period.'}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the spirituality scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to spirituality improved during the observational period.'}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the benefits of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to benefits of caregiving improved during the observational period.'}, {'measure': 'Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale', 'timeFrame': 'Baseline, Day 60', 'description': 'The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the caregiver feelings scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to caregiver feelings improved during the observational period.'}, {'measure': 'Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period', 'timeFrame': 'Up to Day 60', 'description': 'Measured through interviews with the informal caregiver using the Resource Utilization Inventory.'}, {'measure': 'Number of PWD Inpatient Admissions During Study Period', 'timeFrame': 'Up to Day 60', 'description': 'Measured through interviews with the informal caregiver using the Resource Utilization Inventory.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Assessment In Advanced Dementia (PAINAD) Score', 'timeFrame': 'Baseline, Day 60', 'description': '5-item assessment of pain in individuals with advanced dementia. Items are ranked on a 3-point Likert scale from 0 to 2. The total score is the sum of responses and ranges from 0 (no pain) to 10 (severe pain). An increase in scores indicates pain increased during the observational period.'}, {'measure': 'Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score', 'timeFrame': 'Baseline, Day 60', 'description': '13-item tool that measures caregiver perceptions of Behavioral and Psychological Symptoms of Dementia (BPSD). For each item, The severity of the reported symptoms is assessed on a 3-point scale. The total severity score ranges from 0 to 36 with higher scores representing worse severity. An increase in score indicates severity of BPSD increased during the observational period.'}, {'measure': 'Number of PWD Who Use Antipsychotics During Study Period', 'timeFrame': 'Up to Day 60', 'description': 'Measured via patient medication record.'}, {'measure': 'Number of PWD Who Use Analgesics During Study Period', 'timeFrame': 'Up to Day 60', 'description': 'Measured via patient medication record.'}, {'measure': 'Number of PWD Outpatient Visits During Study Period', 'timeFrame': 'Up to Day 60'}, {'measure': 'Number of PWD Primary Care Provider Contacts During Study Period', 'timeFrame': 'Up to Day 60'}, {'measure': 'Change in Zarit Burden Inventory Score Among Caregivers', 'timeFrame': 'Baseline, Day 60', 'description': '22-item self-assessment of burden experienced by caregivers. Items are ranked on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 88, where: 0 - 21 = little or no burden; 21 - 40 = mild to moderate burden; 41 - 60 = moderate to severe burden; and 61 - 88 = severe burden. An increase in scores indicates burden increased during the observational period.'}, {'measure': 'Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers', 'timeFrame': 'Baseline, Day 60', 'description': '9-item measurement of depression in which caregivers indicate how often they have been bothered by specific problems over the previous 2 weeks. Items are ranked on 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater severity of depression.'}, {'measure': 'Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers', 'timeFrame': 'Baseline, Day 60', 'description': '12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Physical Composite Scores (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': 'Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers', 'timeFrame': 'Baseline, Day 60', 'description': '12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12: a mental component score (MCS-12) and a physical component score (PCS-12). Mental Health Composite Scores (MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '32320844', 'type': 'DERIVED', 'citation': 'Bristol AA, Convery KA, Sotelo V, Schneider CE, Lin SY, Fletcher J, Rupper R, Galvin JE, Brody AA. Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers. Contemp Clin Trials. 2020 Jun;93:106005. doi: 10.1016/j.cct.2020.106005. Epub 2020 Apr 19.'}]}, 'descriptionModule': {'briefSummary': "Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare, most home healthcare clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. This study will therefore utilize a cluster randomized controlled design at 3 study sites to examine the ability of a multi-component evidence-based practice primary palliative care quality improvement program for home healthcare registered nurses, occupational therapists and physical therapists to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PWD over the age of 65\n* Admitted to one of the three HHC agencies\n* The patient and family caregiver speak English and/or Spanish.\n* The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient.\n* Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).\n\nExclusion Criteria:\n\n* Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety.\n* PWD residing in assisted living facilities or board and care homes\n* PWD solely receiving infusion or home health aide services.'}, 'identificationModule': {'nctId': 'NCT03255967', 'briefTitle': 'Dementia Symptom Management at Home Program', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Multisite Cluster RCT of the Dementia Symptom Management at Home Program', 'orgStudyIdInfo': {'id': '17-00810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QI program care', 'description': 'DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program', 'interventionNames': ['Behavioral: DSM-H']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Receive usual care from a care team who has not received the performance improvement program', 'interventionNames': ['Behavioral: Standard of Care']}], 'interventions': [{'name': 'DSM-H', 'type': 'BEHAVIORAL', 'description': 'Multi-modal quality improvement program for improving the quality of care provided to person with dementia (PWD)-informal caregiver dyads through HHC', 'armGroupLabels': ['QI program care']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'Subjects receive care through usual home healthcare assignment process.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Abraham Brody, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}