Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:18 AM
Study NCT ID:
NCT07440602
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
From FAST to FAST BEE - Video-Based Stroke Mnemonic Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006266', 'term': 'Health Education'}], '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'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Not applicable. Single-group online educational evaluation; no masking planned.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phase 1: Questionnaire validation (pre-roll-out)\n\n* CVI: 8-12 experts (stroke neurology, EM, EMS/public education). 4-point scales for Relevance and Clarity (agreement = 3-4).\n* Cognitive interviews: 8-10 students (think-aloud/probing on Q1-Q6 + video comprehension).\n* Inter-rater reliability: two blinded raters score a 10-20% sample (≥50 responses) on Q1/Q2 using a rubric.\n\nPhase 1 A precedes participant enrolment for Phase 2. Items flagged as I-CVI \\<0.78 or with recurrent cognitive interview issues will be revised and, where feasible, re-checked with 3-5 experts before locking the questionnaire and scoring rubric Phase 1 A2: Child/Adolescent Questionnaire (Ages 13-17) would be separately validated before usage utilising the same methodology.\n\nPhase 2 This is a single-group, post-test educational evaluation. Participants complete the study in one sitting (\\~6-8 minutes), primarily online via an institutional Google Form. If feasible, an equivalent in-person classroom delivery will'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scenario Application (Q2)', 'timeFrame': 'Immediately after video viewing (same sitting)', 'description': 'Score 1 point each for recognizing balance/diplopia as stroke signs and mentioning emergency action. Score range; 0-2'}, {'measure': 'Recall Score (Q1)', 'timeFrame': 'Immediately after video viewing (same sitting)', 'description': 'Number of mnemonic elements correctly recalled (0-7 points: F, A, S, T, B, E (eyes), E (emergency)).'}, {'measure': 'Action Awareness (Q3/Q5b)', 'timeFrame': 'Immediately after video viewing (same sitting)', 'description': 'Likert score (1-5) on intent to call 112; we take the higher of two related items (Q3: "likelihood to call," Q5b: "usefulness for action").'}, {'measure': 'Composite Endpoint - Usefulness Index (0-100%)', 'timeFrame': 'Immediately after video viewing (same sitting)', 'description': 'A weighted score combining recall, scenario, and action awareness (higher indicates better performance).\n\nCalculation: 40%(Q1/7) + 30%(Q2/2) + 30%\\*(max(Q3,Q5b)/5). Interpretation (pilot): Mean ≥70% suggests good mnemonic retention/action; 50-69% mixed results; \\<50% poor retention/application.'}], 'secondaryOutcomes': [{'measure': 'Perceived Usefulness of FAST BEE', 'timeFrame': 'Immediately after video viewing (same sitting)', 'description': "Participants' perceived usefulness of FAST BEE for recognising stroke signs (Q5a) and for remembering to act (Q5b), compared amongst different demographic subgroups."}, {'measure': 'Memorability Comparison: FAST BEE versus BE FAST', 'timeFrame': 'Immediately after video viewing (same sitting)', 'description': "Comparison of participants' perceived memorability of FAST BEE versus the standard BE FAST mnemonic (Q4), analysed amongst different demographic subgroups."}, {'measure': 'Qualitative Feedback on FAST BEE', 'timeFrame': 'Immediately after video viewing (same sitting)', 'description': 'Free-text qualitative feedback on FAST BEE (clarity, suggestions) to refine the mnemonic and video for public and school settings.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke awareness', 'stroke', 'FAST BEE', 'FAST', 'BE FAST', 'Health education / public education'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This online study evaluates immediate learning outcomes after viewing a short animated FAST BEE stroke-education video (1 minute 51 seconds). After providing electronic consent (and for adolescents aged 13-17 years, parental/guardian consent plus participant assent), participants will watch the video and complete a brief online questionnaire.\n\nThe questionnaire assesses (1) recall of FAST BEE elements, (2) ability to apply FAST BEE to a stroke scenario involving balance and double vision, and (3) intention to take emergency action (calling emergency services).', 'detailedDescription': 'Traditional stroke-recognition campaigns commonly teach the FAST mnemonic (Face, Arm, Speech, Time to call emergency services). While FAST captures frequent stroke presentations, it may not highlight symptoms that can occur in posterior circulation strokes, such as sudden imbalance (ataxia/vertigo) or visual disturbance (blurred vision/double vision). The FAST BEE mnemonic (Face, Arm, Speech, Time, Balance, Eyes, Emergency) was developed by the World Stroke Organization Prehospital Care Task Force to address this gap by adding Balance and Eyes checks and reinforcing emergency action.\n\nThis study is an educational, minimal-risk evaluation using an ultra-brief (1 minute 51 seconds) animated FAST BEE video embedded in an online survey to standardise exposure and assess immediate learning outcomes. The study is conducted via institutional Google Forms as an online-only activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults (aged ≥18)who are able to give consent.\n\nAbility to view and understand the video (in English) and complete the online\n\nMinors (\\<18 years, \\>13 years) only if accompanied by documented parental/guardian consent and child assent, in accordance with ICMR guidelines.\n\nExclusion Criteria:\n\nDeclines participation or exits before completing the survey.\n\nDuplicate or blank submissions: responses with identical timestamps/data or \\>50% missing primary endpoint items will be removed.\n\nFor minors: lack of parental consent or child assent.'}, 'identificationModule': {'nctId': 'NCT07440602', 'acronym': 'FAST BEE', 'briefTitle': 'From FAST to FAST BEE - Video-Based Stroke Mnemonic Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Jubilee Mission Medical College and Research Institute'}, 'officialTitle': 'A Questionnaire-Based Evaluation of Knowledge Recall, Application, and Action Awareness After Viewing the FAST BEE Stroke Education Video', 'orgStudyIdInfo': {'id': '10/26/IEC/JMMC&RI'}, 'secondaryIdInfos': [{'id': 'U1111-1334-4700', 'type': 'OTHER', 'domain': 'World Health Organisation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FAST BEE Video Educational Intervention', 'description': 'Participants complete electronic informed consent, view a 1 minute 51 second FAST BEE animated educational video (Face, Arm, Speech, Time, Balance, Eyes, Emergency), and immediately complete a structured online questionnaire assessing recall, scenario application, and action awareness (6-8 minutes total). The study is conducted online via institutional Google Form.', 'interventionNames': ['Other: FAST BEE Stroke Education Video (1 minute 51 seconds)']}], 'interventions': [{'name': 'FAST BEE Stroke Education Video (1 minute 51 seconds)', 'type': 'OTHER', 'otherNames': ['FAST BEE animated video', 'FAST BEE questionnaire'], 'description': 'A 1 minute 51 second animated educational video introducing the FAST BEE mnemonic (Face, Arm, Speech, Time, Balance, Eyes, Emergency). The video depicts stroke scenarios including balance problems and double vision and emphasises calling emergency services (112) at "Time" and again at the end. The video is embedded within a Google Form (online-only) for standardised exposure. Immediately after viewing, participants complete a questionnaire assessing recall, scenario application, and action awareness.', 'armGroupLabels': ['FAST BEE Video Educational Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thrissur', 'state': 'Kerala', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Jubilee Mission Medical Collage & Research Institute', 'geoPoint': {'lat': 10.51667, 'lon': 76.21667}}], 'centralContacts': [{'name': 'Dr.Siju.V Abraham, M.B.B.S,M.D', 'role': 'CONTACT', 'email': 'sijuvabraham@gmail.com', 'phone': '+91 9447754321'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jubilee Mission Medical College and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in the Department of Emergency Medicine', 'investigatorFullName': 'Siju V Abraham, MD', 'investigatorAffiliation': 'Jubilee Mission Medical College and Research Institute'}}}}