Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-20 @ 9:38 PM
Study NCT ID:
NCT02213458
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2014-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Care Ecosystem: Navigating Patients and Families Through Stages of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'katherine.possin@ucsf.edu', 'phone': '(415) 476-1889', 'title': 'Dr. Katherine Possin', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The economic outcomes are not reported beyond 12-month follow-up and were based only on survey data. Our sample likely differs in important ways from samples from similar programs that do not have a randomized control condition. During our recruitment and consent process, the only potential benefit communicated to prospective enrollees was that participation might inform and advance the quality of care provided to patients with dementia (PWDs) and their caregivers in the future.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program\n\nNavigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).', 'otherNumAtRisk': 1024, 'deathsNumAtRisk': 1024, 'otherNumAffected': 0, 'seriousNumAtRisk': 1024, 'deathsNumAffected': 74, 'seriousNumAffected': 269}, {'id': 'EG001', 'title': 'Survey of Care', 'description': 'Control group that will undergo the same regular assessments as patients enrolled in Navigated Care', 'otherNumAtRisk': 536, 'deathsNumAtRisk': 536, 'otherNumAffected': 0, 'seriousNumAtRisk': 536, 'deathsNumAffected': 39, 'seriousNumAffected': 143}], 'seriousEvents': [{'term': 'Overnight hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1024, 'numEvents': 433, 'numAffected': 218}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 194, 'numAffected': 116}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe fall', 'notes': 'Falls resulting in major injury (broken bone, major bleeding, or loss of consciousness)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1024, 'numEvents': 57, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 536, 'numEvents': 34, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year", 'denoms': [{'units': 'Participants', 'counts': [{'value': '504', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program\n\nNavigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).'}, {'id': 'OG001', 'title': 'Survey of Care', 'description': 'Control group that will undergo the same regular assessments as patients enrolled in Navigated Care'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.43', 'spread': '5.64', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '5.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.539', 'ciLowerLimit': '.259', 'ciUpperLimit': '1.337', 'groupDescription': 'Linear mixed effects model', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Controlling for dementia severity (QDRS)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to one year', 'description': "An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset of caregivers with completed QDRS and Quality of Life questionnaires at baseline and 12 months'}, {'type': 'SECONDARY', 'title': 'Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program\n\nNavigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).'}, {'id': 'OG001', 'title': 'Survey of Care', 'description': 'Control group that will undergo the same regular assessments as patients enrolled in Navigated Care'}], 'classes': [{'categories': [{'measurements': [{'value': '.0483', 'spread': '.703', 'groupId': 'OG000'}, {'value': '.175', 'spread': '.840', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.138', 'ciLowerLimit': '-.295', 'ciUpperLimit': '-.020', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model controlling for dementia severity (QDRS)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to one year', 'description': 'Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.', 'unitOfMeasure': 'number of encounters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of patients with complete data on QDRS and emergency department visits at baseline'}, {'type': 'SECONDARY', 'title': 'Change in Caregiver Burden, Baseline to One Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program\n\nNavigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).'}, {'id': 'OG001', 'title': 'Survey of Care', 'description': 'Control group that will undergo the same regular assessments as patients enrolled in Navigated Care'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.682', 'spread': '8.144', 'groupId': 'OG000'}, {'value': '-1.482', 'spread': '8.641', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.902', 'ciLowerLimit': '-3.885', 'ciUpperLimit': '-0.080', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Linear mixed model controlling for dementia severity (QDRS)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to one year', 'description': 'Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of patients with complete data on QDRS and Zarit burden at baseline'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Dementia Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program\n\nNavigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).'}], 'classes': [{'categories': [{'title': 'Very satisfied with Care Ecosystem services', 'measurements': [{'value': '148', 'groupId': 'OG000'}]}, {'title': 'Satisfied with Care Ecosystem services', 'measurements': [{'value': '107', 'groupId': 'OG000'}]}, {'title': 'Neutral toward Care Ecosystem services', 'measurements': [{'value': '57', 'groupId': 'OG000'}]}, {'title': 'Unsatisfied with Care Ecosystem services', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Very unsatisfied with Care Ecosystem services', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One year', 'description': "A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Navigated Care caregivers with completed caregiver satisfaction questionnaire at 12 months'}, {'type': 'SECONDARY', 'title': 'Change in Caregiver Depression, Baseline to One Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program\n\nNavigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).'}, {'id': 'OG001', 'title': 'Survey of Care', 'description': 'Control group that will undergo the same regular assessments as patients enrolled in Navigated Care'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.831', 'spread': '4.312', 'groupId': 'OG000'}, {'value': '-0.238', 'spread': '4.053', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.143', 'ciLowerLimit': '-2.154', 'ciUpperLimit': '-0.132', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to one year', 'description': 'Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Caregiver Self-efficacy, Baseline to One Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program\n\nNavigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).'}, {'id': 'OG001', 'title': 'Survey of Care', 'description': 'Control group that will undergo the same regular assessments as patients enrolled in Navigated Care'}], 'classes': [{'categories': [{'measurements': [{'value': '1.356', 'spread': '3.038', 'groupId': 'OG000'}, {'value': '1.043', 'spread': '2.647', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.635', 'ciLowerLimit': '-0.135', 'ciUpperLimit': '1.405', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Controlling for dementia severity (QDRS)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to one year', 'description': 'A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Dyads with baseline data on dementia severity (QDRS) and self-efficacy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program\n\nNavigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).'}, {'id': 'FG001', 'title': 'Survey of Care', 'description': 'Control group that will undergo the same regular assessments as patients enrolled in Navigated Care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1024'}, {'groupId': 'FG001', 'numSubjects': '536'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '970'}, {'groupId': 'FG001', 'numSubjects': '526'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'No longer meets criteria: caregiver deceased', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer meets criteria: caregiver no longer caregiving', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer meets criteria: caregiver too sick to participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer meets criteria: patient moved out of state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Refused re-consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1024', 'groupId': 'BG000'}, {'value': '536', 'groupId': 'BG001'}, {'value': '1560', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program\n\nNavigated Care: Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).'}, {'id': 'BG001', 'title': 'Survey of Care', 'description': 'Control group that will undergo the same regular assessments as patients enrolled in Navigated Care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '783', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '1162', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.1', 'spread': '8.66', 'groupId': 'BG000'}, {'value': '78.1', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '78.1', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '656', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '992', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '911', 'groupId': 'BG000'}, {'value': '477', 'groupId': 'BG001'}, {'value': '1388', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '825', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '1272', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1024', 'groupId': 'BG000'}, {'value': '536', 'groupId': 'BG001'}, {'value': '1560', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-06', 'size': 95185, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-22T19:10', 'hasProtocol': True}, {'date': '2018-08-06', 'size': 137306, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-22T19:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2014-08-07', 'resultsFirstSubmitDate': '2021-07-20', 'studyFirstSubmitQcDate': '2014-08-07', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-13', 'studyFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Quality of Life-Alzheimer's Disease, Change From Baseline to 1 Year", 'timeFrame': 'Baseline to one year', 'description': "An established 13-item measure, with a 1-4 ordinal scale for each item, to obtain a rating of the patient's quality of life from the caregiver. Item scores are summed for a total score ranging from 13-52, with higher scores representing better quality of life"}], 'secondaryOutcomes': [{'measure': 'Change in Caregiver Reported Rate of Emergency Department Utilization: Baseline to One Year', 'timeFrame': 'Baseline to one year', 'description': 'Health care utilization based upon caregiver survey to assess emergency department, hospitalization, and ambulance use rates. To be confirmed using Medicare claims data.'}, {'measure': 'Change in Caregiver Burden, Baseline to One Year', 'timeFrame': 'Baseline to one year', 'description': 'Zarit Burden Interview (short version). An established 12-item measure, with a 0-4 ordinal scale for each item, to measure caregiver burden. Item scores are summed for a total score ranging from 0-48, with higher scores representing higher levels of burden.'}, {'measure': 'Satisfaction With Dementia Care', 'timeFrame': 'One year', 'description': "A novel 1-item measure, with a 1-5 ordinal scale, to measure caregiver satisfaction with dementia care provided by the patient's clinical team. Also, one question asking caregivers whether they would recommend the Care Ecosystem to another caregiver. Collected in the treatment group only."}, {'measure': 'Change in Caregiver Depression, Baseline to One Year', 'timeFrame': 'Baseline to one year', 'description': 'Patient Health Questionnaire 9 (PHQ-9). Higher scores represent more severe depression. Scores range from 0-27.'}, {'measure': 'Change in Caregiver Self-efficacy, Baseline to One Year', 'timeFrame': 'Baseline to one year', 'description': 'A novel 4-item measure on a 1-5 ordinal scale to measure self-efficacy around dementia caregiving. Higher scores represent greater self-efficacy. Scores range from 5-15.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pragmatic Clinical Trial', 'Family Caregivers', 'Patient Care Management'], 'conditions': ['Dementia', 'Alzheimer Disease', 'Dementia, Vascular', 'Lewy Body Disease', 'Frontotemporal Lobar Degeneration', 'Memory Disorders']}, 'referencesModule': {'references': [{'pmid': '37721734', 'type': 'RESULT', 'citation': 'Guterman EL, Kiekhofer RE, Wood AJ, Allen IE, Kahn JG, Dulaney S, Merrilees JJ, Lee K, Chiong W, Bonasera SJ, Braley TL, Hunt LJ, Harrison KL, Miller BL, Possin KL. Care Ecosystem Collaborative Model and Health Care Costs in Medicare Beneficiaries With Dementia: A Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2023 Nov 1;183(11):1222-1228. doi: 10.1001/jamainternmed.2023.4764.'}, {'pmid': '36331050', 'type': 'RESULT', 'citation': 'Liu AK, Possin KL, Cook KM, Lynch S, Dulaney S, Merrilees JJ, Braley T, Kiekhofer RE, Bonasera SJ, Allen IE, Chiong W, Clark AM, Feuer J, Ewalt J, Guterman EL, Gearhart R, Miller BL, Lee KP. Effect of collaborative dementia care on potentially inappropriate medication use: Outcomes from the Care Ecosystem randomized clinical trial. Alzheimers Dement. 2023 May;19(5):1865-1875. doi: 10.1002/alz.12808. Epub 2022 Nov 4.'}, {'pmid': '31566651', 'type': 'RESULT', 'citation': 'Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, Hooper SM, Allen IE, Braley T, Bernstein A, Rosa TD, Harrison K, Begert-Hellings H, Kornak J, Kahn JG, Naasan G, Lanata S, Clark AM, Chodos A, Gearhart R, Ritchie C, Miller BL. Effect of Collaborative Dementia Care via Telephone and Internet on Quality of Life, Caregiver Well-being, and Health Care Use: The Care Ecosystem Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1658-1667. doi: 10.1001/jamainternmed.2019.4101.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized clinical trial evaluating the benefits of a program that supports model care for persons with dementia and their family caregivers. Subjects were recruited from California, Nebraska and Iowa. Subjects determined to be eligible were consented and randomized into one of two groups. Two thirds of patients were enrolled into Navigated Care that provided them with assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. One third of patients were enrolled to a control group, entitled Survey of Care. Outcomes include quality of life, health care utilization, caregiver burden, satisfaction with care, caregiver depression, and caregiver self-efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "This study will enroll patients as well as their primary caregivers as research participants.\n\nInclusion criteria for patient participants:\n\n1. Patient has a diagnosis of dementia with a progressive course\n2. Patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study\n3. Patient is covered by Medicare or Medi-caid or is Medi-pending\n4. Patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review\n5. Patient speaks either English, Cantonese, Mandarin, or Spanish\n6. Patient lives in California or Nebraska or Iowa\n7. Patient is age 45 or older\n\nInclusion criteria for caregiver participants:\n\n1. Caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study\n2. Caregiver speaks either English, Cantonese, Mandarin, or Spanish\n3. Caregiver is a legal adult\n\nExclusion Criteria:\n\n1. Patient resides in a nursing home or skilled nursing facility at time of enrollment\n2. Participant is enrolled in a similar clinical trial that precludes their participation in our trial\n3. Patient is pregnant"}, 'identificationModule': {'nctId': 'NCT02213458', 'briefTitle': 'Care Ecosystem: Navigating Patients and Families Through Stages of Care', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'University of California, San Francisco (UCSF) and University of Nebraska Medical Center (UNMC) Care Ecosystem', 'orgStudyIdInfo': {'id': '1C12013003302'}, 'secondaryIdInfos': [{'id': '5R01AG056715', 'link': 'https://reporter.nih.gov/quickSearch/5R01AG056715', 'type': 'NIH'}, {'id': '1C1CMS331346', 'type': 'OTHER_GRANT', 'domain': 'Centers for Medicare and Medicaid Services'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navigated Care', 'description': 'Comprehensive longitudinal continuing care program', 'interventionNames': ['Behavioral: Navigated Care']}, {'type': 'NO_INTERVENTION', 'label': 'Survey of Care', 'description': 'Control group that will undergo the same regular assessments as patients enrolled in Navigated Care'}], 'interventions': [{'name': 'Navigated Care', 'type': 'BEHAVIORAL', 'description': 'Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a "dashboard" functions as a patient care management system used by Care Team Navigators (CTNs).', 'armGroupLabels': ['Navigated Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Katherine L Possin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nebraska', 'class': 'OTHER'}, {'name': 'Centers for Medicare and Medicaid Services', 'class': 'FED'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}