Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 4:27 AM
Study NCT ID:
NCT03916718
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2019-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Care EcoSystem: Ochsner Health System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of ED and Hospital Admissions', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Cost'}, {'measure': 'Quick Dementia Rating Scale (QDRS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Construct: Dementia severity Sum total score Normal 0-1 Mild cognitive impairment 2-5 Mild dementia 6-12 Moderate dementia 13-20 Severe dementia 20-30'}, {'measure': 'Quality of Life in Dementia (QUALI-DEM)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Construct: Dementia patient quality of life Subscales Care Relationship (0-9) Positive Affect (0-12) Negative Affect (0-6) Restless Tense Behavior (0-9) Social Relations (0-9) Social Isolation (0-9)\n\nHigher scores= more of that behavior'}, {'measure': 'Zarit Caregiver Burden Scale- Short Form', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Construct: Family/Caregiver quality of life Sum total score 0-48, higher scores indicate more burden'}], 'secondaryOutcomes': [{'measure': 'Rate of Falls', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Rate of UTIs', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Rate of medication change', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://memory.ucsf.edu/care-ecosystem', 'label': 'UCSF Care Ecosystem'}]}, 'descriptionModule': {'briefSummary': '1. To determine the feasibility and acceptability of the Care Ecosystem program in the Ochsner clinical setting.\n2. To assess the effect of the Care Ecosystem program on health care cost and quality care quality as measured by primary outcome variables.\n\n * Adapted from the Care Ecosystem, memory.ucsf.edu/Care-Ecosystem'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target population includes patients seen at Ochsner Clinic Foundation, \\>=55 years old, diagnosed with dementia, and meeting other inclusion/exclusion criteria. this study will recruit subjects identified as high utilizers of the Ochsner System. This will be defined by \\>= 2 ED visits, \\>= 2 Hospitalizations, or some combination prior to baseline. We will co-variate by insurance plan.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female ≥55 years of age at baseline\n* Probable dementia diagnosis as evidenced by one or more of the following criteria:\n\n * Dementia listed on medical record problem list as of January 1, 2015 or later, or, in the opinion of the referring provider has dementia\n * Prescribed with any of the following: donepezil, memantine, galantamine HBR, rivastigmine, or tartrate; or, in the opinion of the referring provider, could take such medication\n* Lives in community\n\nExclusion Criteria:\n\n* Documented history of Multiple Sclerosis, ALS, Traumatic Brain Injury, Huntington's Disease, Schizophrenia, Bipolar Disorder, or current Substance Abuse Disorder\n* Lives in a nursing home or assisted living facility\n* Unable to complete monthly telehealth or phone visits"}, 'identificationModule': {'nctId': 'NCT03916718', 'briefTitle': 'Care EcoSystem: Ochsner Health System', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'The Dementia Care EcoSystem: The Feasibility of a Care Management Program Addressing Healthcare Quality, Access, and Cost for Patients With Dementia and Their Caregivers', 'orgStudyIdInfo': {'id': '2018241'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dementia', 'description': 'The target population includes patients seen at Ochsner Clinic Foundation, \\>=55 years old, diagnosed with dementia, and meeting other inclusion/exclusion criteria. this study will recruit subjects identified as high utilizers of the Ochsner System. This will be defined by \\>= 2 ED visits, \\>= 2 Hospitalizations, or some combination prior to baseline. We will co-variate by insurance plan.', 'interventionNames': ['Behavioral: Care EcoSystem']}], 'interventions': [{'name': 'Care EcoSystem', 'type': 'BEHAVIORAL', 'description': 'This is a care management program and health care outcomes feasibility study utilizing the dementia Care Ecosystem (CE) program developed at UCSF and tailored to high need Ochsner PWD (patient with dementia) and their CGs (caregivers). Dyads (CGs and PWD) will receive a tailored clinical assessment addressing dementia severity, PWD and CG needs, education/strategies to management common dementia issues, medical issues and medication reconciliation, caregiver wellness strategies, linkages to community-based resources, advance care planning, education about the risk of ED and hospitalization, and care coordination with other specialties. Dyads will be followed on a monthly basis to monitor needs, provide support, and problem solve issues.', 'armGroupLabels': ['Dementia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Health System', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'R. John Sawyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ochsner Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ochsner Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}