Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:25 AM
Study NCT ID:
NCT07414303
Status:
TERMINATED
Last Update Posted:
2026-02-17
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of an Evidence-Based Educational Resource for Children With Mild Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI transitioned to a new institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engagement', 'timeFrame': 'through study completion, an average of 3 years', 'description': '\\# of Advisory Board members'}, {'measure': 'Engagement', 'timeFrame': 'through study completion, an average of 3 years', 'description': '\\# of Engagment Partners'}, {'measure': 'Engagement', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Feedback and Satisfaction on The Patient Engagement in Research Scale (PEIRS). Total scores are calculated on a scale of 0 to 100, where higher scores indicate more meaningful engagement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['concussion', 'mTBI'], 'conditions': ['Concussion, Mild Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, observational study is to (1) collaborate with our stakeholders to identify essential mTBI-information from existing evidence-based materials to develop a Post-mTBI Educational Resource for children with mTBI and their parents and (2) implement our Post-mTBI Educational Resource into clinical practice to determine feasibility, acceptability, and appropriateness at Baylor Scott and White (BSW) clinical sites that treat children with mTBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potential stakeholders will be between the ages of 8 and 99 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children and young adults who are student athletes\n* they have experienced a mTBI\n* parents, coaches, and professional stakeholders (e.g., athletic trainers, school nurses, school administrators, physicians, healthcare administrators, local and national entities, community partners).\n* Stakeholders were part of our previous Engagement Award.\n\nExclusion Criteria:\n\n* Individuals younger than 8 years old\n* Anyone who does not meet the above criteria'}, 'identificationModule': {'nctId': 'NCT07414303', 'acronym': 'POCKIT', 'briefTitle': 'Implementation of an Evidence-Based Educational Resource for Children With Mild Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Implementation of an Evidence-Based Educational Resource for Children With Mild Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '90IFDV0035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advisory Board (AB)', 'description': 'Our target AB of stakeholders include children and young adults who are student athletes and have experienced mTBI, parents, coaches, and professional stakeholders (e.g., athletic trainers, school nurses, school administrators, physicians, healthcare administrators, local and national entities, community partners)', 'interventionNames': ['Other: Post-mTBI Educational Resource']}], 'interventions': [{'name': 'Post-mTBI Educational Resource', 'type': 'OTHER', 'description': 'Activate clinicians and clinic administrators at BSW clinical sites that treat children with mTBI to implement the Post-mTBI Educational Resource.', 'armGroupLabels': ['Advisory Board (AB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75034', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'facility': 'BSW Primary Care at The Star', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '75034', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'facility': 'BSW Sports Concussion Program', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '76502', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': "McLane Children's Hospital at BSW Temple Medical Center", 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}