Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT05356702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2022-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Brain Health Study: A Pragmatic, Patient-Centered Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3417}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New dementia diagnoses', 'timeFrame': '12 months after index date', 'description': 'Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes'}], 'secondaryOutcomes': [{'measure': 'Healthcare utilization', 'timeFrame': '6 months after index date', 'description': 'Number of primary care visits, laboratory tests performed, neuroimaging tests, and specialty visits or referrals, defined from EHR data'}, {'measure': 'Dementia medications', 'timeFrame': '6 months after index date', 'description': 'Percent of participants who receive new medications for dementia, defined from medication orders or dispensings in the electronic health record'}, {'measure': 'Urgent care/emergency department visits', 'timeFrame': '1 year after index date', 'description': 'Number of urgent care and emergency department visits'}, {'measure': 'Hospitalizations', 'timeFrame': '1 year after index date', 'description': 'Number of inpatient stays'}, {'measure': 'Clinic "no shows"', 'timeFrame': '1 year after index date', 'description': 'Number of scheduled visits missed'}, {'measure': 'Medication adherence', 'timeFrame': '1 year after index date', 'description': 'Proportion of days covered'}, {'measure': 'New dementia diagnoses (secondary definitions)', 'timeFrame': '6 months after index date; 18 months after index date', 'description': 'Dementia diagnosis rate in different time periods than for primary outcome, defined from EHR data'}, {'measure': 'New diagnoses of mild cognitive impairment', 'timeFrame': '12 months after index date', 'description': 'Rate of new diagnoses of mild cognitive impairment following the intervention, defined from EHR data'}, {'measure': 'Rate of accepting brain health visit', 'timeFrame': '3 months after invitation mailed', 'description': 'Proportion of people offered a brain health visit who accept and attend the visit'}, {'measure': 'Positive predictive value of eRADAR algorithm', 'timeFrame': '12 months after index date', 'description': 'Proportion of people with a high risk eRADAR Score who attend a brain health visit who are diagnosed with dementia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '28849435', 'type': 'BACKGROUND', 'citation': 'Lee SJ, Larson EB, Dublin S, Walker R, Marcum Z, Barnes D. A Cohort Study of Healthcare Utilization in Older Adults with Undiagnosed Dementia. J Gen Intern Med. 2018 Jan;33(1):13-15. doi: 10.1007/s11606-017-4162-3. No abstract available.'}, {'pmid': '31612463', 'type': 'BACKGROUND', 'citation': 'Barnes DE, Zhou J, Walker RL, Larson EB, Lee SJ, Boscardin WJ, Marcum ZA, Dublin S. Development and Validation of eRADAR: A Tool Using EHR Data to Detect Unrecognized Dementia. J Am Geriatr Soc. 2020 Jan;68(1):103-111. doi: 10.1111/jgs.16182. Epub 2019 Oct 14.'}, {'pmid': '34702167', 'type': 'BACKGROUND', 'citation': 'Palazzo L, Hsu C, Barnes DE, Gray MF, Greenwood-Hickman MA, Larson EB, Dublin S. Patient and caregiver perspectives on a tool to increase recognition of undiagnosed dementia: a qualitative study. BMC Geriatr. 2021 Oct 26;21(1):604. doi: 10.1186/s12877-021-02523-0.'}]}, 'descriptionModule': {'briefSummary': 'The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.', 'detailedDescription': 'eRADAR stands for "electronic health record (EHR) Risk of Alzheimer\'s and Dementia Assessment Rule." It is a low-cost tool or algorithm that uses readily available EHR data elements to identify high-risk patients. We will conduct a pragmatic randomized controlled trial to assess the impact of implementing eRADAR as part of a supported outreach process on dementia detection rates. We will also explore the impact of eRADAR implementation on healthcare utilization and patient experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No prior diagnosis of dementia (defined from EHR diagnosis codes) and not receiving medications for dementia\n* Active patient at participating clinic\n* Adequate data to calculate eRADAR score\n\nExclusion Criteria:\n\n\\- Currently receiving hospice care'}, 'identificationModule': {'nctId': 'NCT05356702', 'briefTitle': 'The Brain Health Study: A Pragmatic, Patient-Centered Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Low-cost Detection of Dementia Using Electronic Health Records Data: Validation and Testing of the eRADAR Algorithm in a Pragmatic, Patient-centered Trial.', 'orgStudyIdInfo': {'id': '1R01AG067427', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG067427', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain Health Intervention', 'description': '* Calculate eRADAR scores using EHR data to identify eligible individuals\n* Invite eligible individuals for brain health assessment visit\n* Enter results of brain health assessment visit into EHR\n* Provide summary of results and recommended next steps to the Primary Care Physician and participant', 'interventionNames': ['Other: Brain Health Assessment']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Individuals who meet eligibility criteria will receive usual care.'}], 'interventions': [{'name': 'Brain Health Assessment', 'type': 'OTHER', 'description': "Research interventionists, who will be trained and licensed health practitioners (e.g., social workers), will ask participants about changes in memory or thinking and daily function, screen for depression, and administer a standard cognitive screening test. They will use a standardized note template to document results in the participant's EHR. Research interventionists will notify participants and PCPs if follow-up is recommended.", 'armGroupLabels': ['Brain Health Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98166', 'city': 'Burien', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Burien Medical Center', 'geoPoint': {'lat': 47.47038, 'lon': -122.34679}}, {'zip': '98030', 'city': 'Kent', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Kent Medical Center', 'geoPoint': {'lat': 47.38093, 'lon': -122.23484}}, {'zip': '98056', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Renton Medical Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '98112', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente, Capitol Hill', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98115', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Northgate Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Sascha Dublin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KP Washington Health Research Institute'}, {'name': 'Deborah E. Barnes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.', 'ipdSharing': 'YES', 'description': 'This Individual Participant Data (IPD) plan applies to all quantitative study data, such as data collected specifically for the study and those derived from electronic health records (EHR), as well as the data collected via planned study surveys, which include only short qualitative free-text fields. We do not plan to share transcripts from in-depth qualitative interviews or recorded study assessment visits.\n\nData will be maintained on secure servers behind the firewalls at the two study sites: Kaiser Permanente Washington (KPWA) and the University of California, San Francisco (UCSF). De-identified or limited datasets containing individual-level data on which publications are based will be made available to qualified researchers for specified analyses. We will make the data available to users only under a data-use agreement (DUA).', 'accessCriteria': "Individuals interested in using KPWA data will be required to complete a standard form, sign a Data Use Agreement (DUA) and provide documentation of IRB approval. Data may then be accessed by qualified researchers via KPWA's Secure File Transfer (SFT) site. User registration will be required in order to access or download data files. As part of the registration process, users must agree to the conditions of use governing access to the data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}