Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-08 @ 4:01 AM
Study NCT ID:
NCT03639233
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Youth Epilepsy and Successful Self-Management Intervention
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': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-28', 'studyFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of recruiting and enrollment procedures and', 'timeFrame': '8 weeks after getting access to the web intervention', 'description': 'Measure the extent to which the recruitment and enrollment procedures meet the study aims in terms of number of participants log in to the intervention'}, {'measure': 'Acceptability of intervention website users', 'timeFrame': '8 weeks after getting access to the web intervention', 'description': 'and the extent to which users (study subjects) find the intervention easy to use, enjoyable to use, useful, engaging. Acceptability is a multifaceted and complex concept. As such it it is best examined as a system of interacting attributes.'}], 'secondaryOutcomes': [{'measure': 'Participant Well-being', 'timeFrame': '8 weeks after getting access to the web intervention and 8 weeks after that.', 'description': 'measures of overall well-being (EPOCH wellbeing meausre)'}, {'measure': 'Participant Quality of Life', 'timeFrame': '8 weeks after getting access to the web intervention and 8 weeks after that.', 'description': 'measure quality of life in epilepsy (QoLiE-10)'}, {'measure': 'self-management behavior profile', 'timeFrame': '8 weeks after getting access to the web intervention and 8 weeks after that.', 'description': 'measure the frequency of self management behaviors (taking medications, making clinic appointments, speaking with doctor/nurse/teacher) using a measure developed for this study'}, {'measure': 'self-management motivation profile', 'timeFrame': '8 weeks after getting access to the web intervention and 8 weeks after that.', 'description': 'measure the motivations (autonomous and extrinsic reasons for engaging in self management) using an adapted version of a standardized measure of motivation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'This study is designed as a pilot test of the YESS! web-based intervention for adolescents with epilepsy. One hundred twenty participants will be given access to the intervention for a period of eight weeks. The investigators are testing the feasibility and acceptability of the the study procedures, measures and of the intervention itself. The study also evaluats the potential for impact on the users.', 'detailedDescription': 'YESS! is a web-based self management program developed to enhance the motivation and skills of youth with epilepsy.\n\nThis clinical trial uses a pre-test, post-test design where all consenting participants are given access to the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age as above\n* Epilepsy diagnosed by a physician\n* Currently taking anti-seizure medications or use device\n* Ability to understand and respond to questions about health and epilepsy\n* Ability to utilize an internet based intervention website\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT03639233', 'acronym': 'YESS!', 'briefTitle': 'Youth Epilepsy and Successful Self-Management Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Youth Epilepsy and Successful Self-Management Intervention', 'orgStudyIdInfo': {'id': 'STUDY00003214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1', 'description': 'Intervention access', 'interventionNames': ['Behavioral: YESS!']}], 'interventions': [{'name': 'YESS!', 'type': 'BEHAVIORAL', 'description': 'Web based self-management education', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Peter Scal, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'YESS! is a member of the Managing Epilepsy Well (MEW) and the associated shared database of deidentified participant records'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}