Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT06187857
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Virtually Delivered Memory Rehabilitation Protocol in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-11', 'size': 92503, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-11T11:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A feasibility study of twenty-five older adults completing the same virtual procedures.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-12-28', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of study protocols.', 'timeFrame': 'Through study completion, an average of 8 weeks.', 'description': 'To address questions regarding feasibility, the investigators calculated descriptive statistics on sample information and feasibility was set a priori as a completion rate greater than 80% based on previous research.'}], 'secondaryOutcomes': [{'measure': 'Memory Outcomes: Repeatable Battery for Neuropsychological Status', 'timeFrame': 'Through study completion, an average of 8 weeks.', 'description': 'To address secondary outcomes, the investigators calculated reliable change indices for memory outcomes on the Repeatable Battery for Neuropsychological Status. The reliable change indices vary from less than -1.96 to greater than 1.96. Greater than 1.96 represents improved memory functioning.'}, {'measure': 'Memory Outcomes: Ecological Memory Simulations', 'timeFrame': 'Through study completion, an average of 8 weeks.', 'description': 'To address secondary outcomes, the investigators calculated reliable change indices for memory outcomes on the Ecological Memory Simulations. The reliable change indices vary from less than -1.96 to greater than 1.96. Greater than 1.96 represents improved memory functioning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Memory Dysfunction', 'Neurorehabilitation']}, 'referencesModule': {'availIpds': [{'url': 'https://osf.io/cavkf/?view_only=cc219af15f614756b43742875b6b0b39', 'type': 'Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'The investigators conducted a feasibility study of a virtually-delivered adaptation of an ecologically oriented neurorehabilitation of memory (EON-Mem) in improving memory for healthy older adults. The primary purposes of this study included determining the feasibility of conducting EON-Mem virtually with older adults and whether a randomized control trial using EON-Mem in older adults is of value.', 'detailedDescription': 'Twenty-five older adults aged 55 years and older were recruited for participation in the EON-Mem training program adapted and administered virtually. Measures of emotional functioning and cognitive functioning were administered before and following the intervention. Participants attended one virtual treatment session per week for a total of six weeks with daily homework assignments. A priori, feasibility was set at an 80% completion rate. To address questions regarding feasibility, the investigators calculated descriptive statistics on sample information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals 55 and older\n\nExclusion Criteria:\n\n* Evidence of cognitive dysfunction on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) as evidenced by a score of 3.3 or more\n* History of moderate-to-severe TBI\n* History of stroke\n* Dementia/neurological diagnoses\n* Current chemotherapy or radiation\n* Current or history of brain cancer\n* Poor sensory function including uncorrected vision, hearing, or speaking impairments that could interfere with learning the intervention, including nonnative English speakers.'}, 'identificationModule': {'nctId': 'NCT06187857', 'acronym': 'EONMem_OA', 'briefTitle': 'A Virtually Delivered Memory Rehabilitation Protocol in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Brigham Young University'}, 'officialTitle': 'A Feasibility Study of a Virtually Delivered Ecologically Oriented Neurorehabilitation of Memory (EON-MEM) Protocol in Older Adults', 'orgStudyIdInfo': {'id': 'EONMem_OA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ecologically Oriented Neurorehabilitation of Memory (EON-Mem)', 'type': 'BEHAVIORAL', 'description': 'Feasibility study of a virtually-delivered adaptation of an ecologically oriented neurorehabilitation of memory (EON-Mem) in improving memory for healthy older adults'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84604', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Brigham Young Unversity', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/cavkf/?view_only=cc219af15f614756b43742875b6b0b39', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'The dataset will be published in January 2024 and will remain on the website.', 'ipdSharing': 'YES', 'description': 'The investigators will be sharing study procedures, study design, and de-identified participant data on the Open Science Framework (OSF).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brigham Young University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Whitney Allen', 'investigatorAffiliation': 'Brigham Young University'}}}}