Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT04812769
Status:
WITHDRAWN
Last Update Posted:
2021-12-01
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two participating nursing homes will be assigned to the intervention. One participating nursing home will serve as a control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Principal Investigator is taking a leave of absence. Study terminated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of antibiotic therapy in nursing home residents', 'timeFrame': '6 months', 'description': 'The primary outcome will be defined as the duration of antibiotic therapy in nursing home residents with AD/ADRD, measured as the total days of antibiotic therapy per 1000 resident-days among residents with ADRD.'}], 'secondaryOutcomes': [{'measure': 'Number of antibiotic prescriptions in nursing home residents', 'timeFrame': '6 months', 'description': 'The secondary outcome will be defined as the number of antibiotic prescriptions in nursing home residents with AD/ADRD, defined as the total number of antibiotic prescriptions per 1000 resident-days among residents with AD/ADRD.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Dementia", 'Nursing Homes', 'Antibiotics', 'Dementia']}, 'descriptionModule': {'briefSummary': 'Pilot study to evaluate the feasibility of a pilot embedded pragmatic cluster randomized controlled trial to reduce the duration of antibiotic therapy and number of antibiotic prescriptions in nursing home residents with AD/ADRD.', 'detailedDescription': 'The overall objective of the proposed investigation is to assess the feasibility of a pilot embedded pragmatic cluster randomized controlled trial (ePCT) to reduce the duration of antibiotic therapy and number of antibiotic prescriptions among nursing home residents with AD/ADRD. With the support of three independently owned and operated nursing homes that are unaffiliated with an academic medical center, we have developed the multicomponent intervention, eCARE-ID (Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases). eCARE-ID consists of three components: 1) Tele-ID video clinical consultation services for nursing home residents; 2) electronic consultation (e-consultation) services for healthcare personnel at participating nursing homes; and 3) Tele-ID video antibiotic stewardship services for healthcare personnel including pharmacists at participating nursing homes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria - residence in a participating nursing home\n\nExclusion criteria:\n\n\\- Not willing to consent to the study'}, 'identificationModule': {'nctId': 'NCT04812769', 'acronym': 'eCARE-ID', 'briefTitle': 'Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Electronic Consultation for AD/ADRD Residents Experiencing Infectious Diseases', 'orgStudyIdInfo': {'id': '2000029812'}, 'secondaryIdInfos': [{'id': 'RFA-IMPACT-20-P02A', 'type': 'OTHER_GRANT', 'domain': 'NIA'}, {'id': 'U54AG063546', 'link': 'https://reporter.nih.gov/quickSearch/U54AG063546', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Two nursing homes will receive the eCARE-ID intervention', 'interventionNames': ['Device: eCARE-ID']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'One control nursing home will receive infectious disease consultations and antibiotic stewardship services per routine practice.', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'eCARE-ID', 'type': 'DEVICE', 'description': 'The intervention, eCARE-ID, consists of: 1) telehealth video clinical consultation services for nursing homes residents; 2) electronic consultation services for healthcare personnel; 3) telehealth video antibiotic stewardship services for healthcare personnel', 'armGroupLabels': ['Intervention']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Standard of care will be delivered to the control home.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Manisha Juthani-Mehta, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Advarra', 'class': 'INDUSTRY'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Brown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}