Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-04-20 @ 6:16 PM
Study NCT ID:
NCT05118503
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2021-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Patient and Caregiver Education After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-11-01', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction survey', 'timeFrame': 'Day 90', 'description': 'Likert-style survey assessing patient satisfaction and perception of the stroke education they received.'}, {'measure': 'Stroke etiology awareness', 'timeFrame': 'Day 90', 'description': 'accurate knowledge of stroke etiology (0=incorrect; 1=correct)'}, {'measure': 'Stroke Patient Education Retention (SPER) survey', 'timeFrame': 'Day 90', 'description': 'Validated measure of stroke patient education as it pertains to their stroke etiology and risk factors with scores of 0-10'}, {'measure': 'EuroQOL-VAS', 'timeFrame': 'Day 90', 'description': 'validated quality of life metric, with scores of 0-100'}], 'secondaryOutcomes': [{'measure': 'Stroke etiology awareness', 'timeFrame': 'Day 7', 'description': 'accurate knowledge of stroke etiology (0=incorrect; 1=correct)'}, {'measure': 'Stroke etiology awareness', 'timeFrame': 'Day 30', 'description': 'accurate knowledge of stroke etiology (0=incorrect; 1=correct)'}, {'measure': 'Stroke risk factor awareness. 7 days', 'timeFrame': 'Day 7', 'description': 'accurate knowledge of stroke risk factors (0=incorrect; 1=correct)'}, {'measure': 'Stroke risk factor awareness, 30 days', 'timeFrame': 'Day 30', 'description': 'accurate knowledge of stroke risk factors (0=incorrect; 1=correct)'}, {'measure': 'Stroke risk factor awareness, 90 days', 'timeFrame': 'Day 90', 'description': 'accurate knowledge of stroke risk factors (0=incorrect; 1=correct)'}, {'measure': 'Stroke prevention med awareness, 7 days', 'timeFrame': 'Day 7', 'description': 'accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)'}, {'measure': 'Stroke prevention med awareness, 30 days', 'timeFrame': 'Day 30', 'description': 'accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)'}, {'measure': 'Stroke prevention med awareness, 90 days', 'timeFrame': 'Day 90', 'description': 'accurate knowledge of stroke prevention medications (0=incorrect; 1=correct)'}, {'measure': 'Patient satisfaction, 7 days', 'timeFrame': 'Day 7', 'description': 'Likert-style survey assessing patient satisfaction and perception of the stroke education'}, {'measure': 'Patient satisfaction, 30 days', 'timeFrame': 'Day 30', 'description': 'Likert-style survey assessing patient satisfaction and perception of the stroke education'}, {'measure': 'SPER, 7 days', 'timeFrame': 'Day 7', 'description': 'Stroke Patient Education Retention (SPER) survey'}, {'measure': 'SPER, 30 days', 'timeFrame': 'Day 30', 'description': 'Stroke Patient Education Retention (SPER) survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute', 'Stroke, Ischemic', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '39082426', 'type': 'DERIVED', 'citation': 'Favilla CG, Reehal N, Cummings SR, Burdett R, Stein LA, Shakibajahromi B, Yuan K, Sloane KL, Kasner SE. Personalized Video-Based Educational Platform to Improve Stroke Knowledge: A Randomized Clinical Trial. J Am Heart Assoc. 2024 Aug 6;13(15):e035176. doi: 10.1161/JAHA.124.035176. Epub 2024 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized pilot trial to evaluate the impact of a customizable stroke education app (vs standard of care discharge education) on patient satisfaction and education retention. The impact of the intervention will be assessed 7, 30, and 90 days post-discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted for ischemic stroke\n* At least 18 years old\n* Patient or caregiver has access to a smart phone, tablet or computer\n* Being discharged to either home or acute rehab\n\nExclusion Criteria:\n\n* Patient or caregivers unable or unwilling to access the customized app with a smartphone, tablet, or computer\n* Being discharged to a skilled nursing facility\n* moderate-to-severe aphasia at the time of enrollment (as per NIHSS scoring) if patient is being enrolled without a caregiver'}, 'identificationModule': {'nctId': 'NCT05118503', 'acronym': 'MyStroke', 'briefTitle': 'Personalized Patient and Caregiver Education After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Personalized Patient and Caregiver Education After Stroke', 'orgStudyIdInfo': {'id': '833723'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Customized education app', 'description': 'A customized URL-based platform will present brief education videos addressing a patients stroke etiology, risk factors, stroke prevention medications, and post-stroke lifestyle issues. This URL will be made available to the patient and caregiver.', 'interventionNames': ['Behavioral: Customized education']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard of care discharge education', 'description': 'Standard discharge education is performed by the bedside nurse at the time of hospital discharge.', 'interventionNames': ['Behavioral: Standard of care discharge education']}], 'interventions': [{'name': 'Customized education', 'type': 'BEHAVIORAL', 'description': 'Half of subjects will receive access to a customized app that will include brief educational videos that have been selected for each patient based on their medical history. These videos will address stroke etiology, underlying risk factors, and stroke prevention medications.', 'armGroupLabels': ['Customized education app']}, {'name': 'Standard of care discharge education', 'type': 'BEHAVIORAL', 'description': 'Half of subjects will be randomized to receive typical discharge education, per the institutional guidelines for standard of care education for stroke patients.', 'armGroupLabels': ['Standard of care discharge education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Christopher Favilla, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurology', 'investigatorFullName': 'Christopher Favilla', 'investigatorAffiliation': 'University of Pennsylvania'}}}}