Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-02 @ 4:42 AM
Study NCT ID:
NCT05451693
Status:
TERMINATED
Last Update Posted:
2025-02-05
First Post:
2022-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outreach-ER: A Dementia Care Intervention 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bhavani.x.kashyap@healthpartners.com', 'phone': '651-495-6363', 'title': 'Bhavani Kashyap, PhD, MBBS', 'organization': 'HealthPartners Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Outreach-ER (People Living With Dementia)', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Outreach-ER (Caregivers of PLWD)', 'description': 'Caregivers of PLWD also participating in the Outreach-ER program.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Outreach-ER', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months', 'description': 'Number of potential participant/care partner dyads contacted. Higher number indicates higher number of attempts as recruitment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Recruitment Rate for Feasibility and Acceptability of Outreach-ER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Outreach-ER', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'Percentage of participant/care partner dyads who enroll and consent \\[range: 0-100%\\]. Higher number indicates more feasibility.', 'unitOfMeasure': 'percentage of attempted recruits', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participant Rate for Feasibility and Acceptability of Outreach-ER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Outreach-ER', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First day of intervention', 'description': 'Percentage of participant/care partner dyads who start Outreach-ER program \\[range: 0-100%\\]. Higher number indicates more feasibility.', 'unitOfMeasure': 'percentage of attempted recruits', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Completion Rate for Feasibility and Acceptability of Outreach-ER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Outreach-ER', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'about 4 months', 'description': 'Percentage of participant/care partner dyads who complete intervention (7 or more visits) \\[range: 0-100%\\]. Higher number indicates more feasibility.', 'unitOfMeasure': 'percentage of enrolled participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'sessions', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Outreach-ER', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'about 4 months', 'description': 'Percentage of participant/care partner dyads who complete each intervention visit \\[range: 0-100%\\].\n\nNumber of total intervention visits completed = total completed visits for the 4 dyads.\n\nNumber of total intervention visits available = 6 visits x 4 dyads = 24 visits. Number of total intervention visits completed/24 total intervention visits x 100 = percentage.\n\nHigher number indicates more feasibility.', 'unitOfMeasure': 'percentage of sessions completed', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sessions', 'denomUnitsSelected': 'sessions'}, {'type': 'PRIMARY', 'title': 'Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'questionnaires', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Outreach-ER', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'about 4 months', 'description': 'Percentage of participant/care partner dyads who complete each questionnaire \\[range: 0-100%\\].\n\nNumber of total questionnaires completed = total completed questionnaires for the 4 dyads.\n\nNumber of total questionnaires available = 3 questionnaires x 4 dyads x 2 visit time points = 24 available questionnaires.\n\nNumber of total questionnaires completed/24 total questionnaires available x 100 = percentage.\n\nHigher number indicates more feasibility.', 'unitOfMeasure': 'percentage of completed questionnaires', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'questionnaires', 'denomUnitsSelected': 'questionnaires'}, {'type': 'SECONDARY', 'title': 'Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Outreach-ER', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'about 4 months', 'description': 'Percentage of care partners that respond to all of the items on each scale \\[range: 0-100%\\]. Higher number indicates more feasibility.', 'unitOfMeasure': 'percentage of completed questions', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Outreach-ER (People Living With Dementia)', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.'}, {'id': 'FG001', 'title': 'Outreach-ER (Caregiver)', 'description': 'Caregiver to the PLWD also participating in the Outreach-ER program.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '4 PLWD 4 Caregivers of PLWD'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Outreach-ER (People Living With Dementia)', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD.\n\nOutreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.'}, {'id': 'BG001', 'title': 'Outreach-ER (Caregivers of PLWD)', 'description': 'Caregivers of PLWD also participating in the Outreach-ER program.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '65', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '66.9', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dementia Type', 'classes': [{'title': "Late Onset Alzheimer's Disease", 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Lewy Body Dementia (Mixed)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': "Alzheimer's Disease with Down Syndrome", 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'No Dementia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-16', 'size': 613625, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-01T11:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Planned recruitment was not feasible.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2022-07-05', 'resultsFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2022-07-08', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-03', 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Attempted Recruits for Feasibility and Acceptability of Outreach-ER', 'timeFrame': '4 months', 'description': 'Number of potential participant/care partner dyads contacted. Higher number indicates higher number of attempts as recruitment.'}, {'measure': 'Recruitment Rate for Feasibility and Acceptability of Outreach-ER', 'timeFrame': '4 months', 'description': 'Percentage of participant/care partner dyads who enroll and consent \\[range: 0-100%\\]. Higher number indicates more feasibility.'}, {'measure': 'Participant Rate for Feasibility and Acceptability of Outreach-ER', 'timeFrame': 'First day of intervention', 'description': 'Percentage of participant/care partner dyads who start Outreach-ER program \\[range: 0-100%\\]. Higher number indicates more feasibility.'}, {'measure': 'Completion Rate for Feasibility and Acceptability of Outreach-ER', 'timeFrame': 'about 4 months', 'description': 'Percentage of participant/care partner dyads who complete intervention (7 or more visits) \\[range: 0-100%\\]. Higher number indicates more feasibility.'}, {'measure': 'Session Specific Completion Rate for Feasibility and Acceptability of Outreach-ER', 'timeFrame': 'about 4 months', 'description': 'Percentage of participant/care partner dyads who complete each intervention visit \\[range: 0-100%\\].\n\nNumber of total intervention visits completed = total completed visits for the 4 dyads.\n\nNumber of total intervention visits available = 6 visits x 4 dyads = 24 visits. Number of total intervention visits completed/24 total intervention visits x 100 = percentage.\n\nHigher number indicates more feasibility.'}, {'measure': 'Questionnaire Specific Response Rate for Feasibility and Acceptability of Outreach-ER', 'timeFrame': 'about 4 months', 'description': 'Percentage of participant/care partner dyads who complete each questionnaire \\[range: 0-100%\\].\n\nNumber of total questionnaires completed = total completed questionnaires for the 4 dyads.\n\nNumber of total questionnaires available = 3 questionnaires x 4 dyads x 2 visit time points = 24 available questionnaires.\n\nNumber of total questionnaires completed/24 total questionnaires available x 100 = percentage.\n\nHigher number indicates more feasibility.'}], 'secondaryOutcomes': [{'measure': 'Completeness of Specific Measures for Feasibility and Acceptability of Outreach-ER', 'timeFrame': 'about 4 months', 'description': 'Percentage of care partners that respond to all of the items on each scale \\[range: 0-100%\\]. Higher number indicates more feasibility.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'This is a feasibility/pilot, prospective cohort study to determine how to implement and refine Outreach-ER intervention for a larger clinical study. A key feature of Outreach-ER is to reach out to people living with dementia (PLWD) and their families following an emergency room visit or hospitalization. The outcome of this study will help in the overall goal of studying the impact of Outreach-ER in a larger clinical study and focus on outcomes relevant to PLWD and their care partners.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population includes people living with dementia (PLWD) who are treated at the Regions Hospital Emergency Department in Saint Paul, MN.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PLWD with a recent Emergency department visit or admission at Regions Hospital\n* Diagnosis of dementia based on international classification of diseases (ICD) Codes in the medical record\n* Provides informed consent prior to participation\n* Must be able to read and speak English\n* PLWD Living at Home\n* Age \\>=18 years for PLWD and their care partner\n\nExclusion Criteria:\n\n* PLWD living in a nursing home/Long term care - Assisted living facility\n* Current involvement in another clinical research study/trial for care partners\n* PLWD medical record number (MRN) on the HealthPartners (HP) exclusion list'}, 'identificationModule': {'nctId': 'NCT05451693', 'briefTitle': 'Outreach-ER: A Dementia Care Intervention Program', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Outreach-ER: A Dementia Care Intervention Program', 'orgStudyIdInfo': {'id': 'A22-086'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Outreach-ER', 'description': 'Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/people living with dementia (PLWD).', 'interventionNames': ['Behavioral: Outreach-ER']}], 'interventions': [{'name': 'Outreach-ER', 'type': 'BEHAVIORAL', 'description': 'The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants.', 'armGroupLabels': ['Outreach-ER']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Regions Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Neuroscience Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Bhavani Kashyap, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Neuroscience Research'}, {'name': 'Leah R Hanson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Neuroscience Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}