Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT06052605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-25
First Post:
2023-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healthy Aging in People With Epilepsy Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-09-18', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dementia Knowledge', 'timeFrame': 'Pre and Post intervention (3 months)', 'description': 'Dementia Knowledge Assessment Tool was designed to measure change in knowledge of dementia including dementia and its progress, support, and care. It contains 21 true/false items.'}, {'measure': 'Health literacy', 'timeFrame': 'Pre and Post intervention (3 months)', 'description': "Short Assessment of Health Literacy-English is an 18-item scale assessing adult's ability to read and understand common medical terms."}, {'measure': 'Health Related Quality of life', 'timeFrame': 'Pre and Post intervention (3 months)', 'description': 'Quality of life in Epilepsy-31 is a self-report questionnaire assessing quality of life in individuals with epilepsy. It measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, physical function, pain, role limitations due to physical problems, health perception, and perceived problems with attention/concentration, language, memory.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to develop and test an educational program about dementia in older adults living with epilepsy. The main questions it aims to answer are:\n\n1. Can providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors improve dementia knowledge and health literacy among older adults with epilepsy?\n2. Can aging related education and resources improve quality of life among older adults with epilepsy?\n\nParticipants will:\n\n* Complete a 12-week group educational program.\n* Complete pre- and post-program evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician\n* Proficiency in English\n\nExclusion Criteria:\n\n* Dementia'}, 'identificationModule': {'nctId': 'NCT06052605', 'acronym': 'HAP-E', 'briefTitle': 'Healthy Aging in People With Epilepsy Program', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Healthy Aging in People With Epilepsy Program (HAP-E): Closing the Gap in Epilepsy Care', 'orgStudyIdInfo': {'id': 'HAPE2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HAP-E Epilepsy Participants', 'interventionNames': ['Behavioral: Healthy Aging in People with Epilepsy Program']}], 'interventions': [{'name': 'Healthy Aging in People with Epilepsy Program', 'type': 'BEHAVIORAL', 'description': 'This a 12-week group educational program providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors.', 'armGroupLabels': ['HAP-E Epilepsy Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Anny Reyes, PhD', 'role': 'CONTACT', 'email': 'anr086@health.ucsd.edu', 'phone': '646-648-7154'}, {'name': 'Anny Reyes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Califonia, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Fellow', 'investigatorFullName': 'Anny Reyes', 'investigatorAffiliation': 'University of California, San Diego'}}}}