- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07636889
Effectiveness of a BEFAST-Based Stroke Education Module on Knowledge, Attitudes and Practices Among Stroke Patients at a Malaysian Tertiary Hospital: A Pre-Post Intervention Study
Stroke is a major health problem in Malaysia. Many stroke patients do not know how to recognize stroke symptoms quickly or when to seek emergency help. The BEFAST mnemonic (Balance, Eyes, Face, Arm, Speech, Time) is a simple tool to help people remember stroke warning signs. This study tests whether a single stroke education session based on BEFAST improves knowledge, attitudes, and emergency response intentions among stroke patients admitted to a Malaysian tertiary hospital. The study will use a pre-post intervention design with follow-up at one month. Participants will be the stroke patients admitted to the neurology ward. They will receive a one-hour structured education module covering BEFAST symptoms, risk factors, and the importance of reaching a hospital within 4.5 hours. Education will is delivered by doctors and nurses using presentations, pamphlets, posters, videos, and follow-up WhatsApp messages.
Outcomes will be assessed using a validated questionnaire measuring knowledge, attitudes, and practices at three time points: before the intervention, immediately after, and at one month. Associations between demographic factors and outcomes will also be explored.
연구 개요
상세 설명
Study Overview
This is a single-centre, pre-post intervention study that will be conducted from September 2024 to September 2025 at Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia, a major tertiary hospital. The study will evaluate the effectiveness of a structured BEFAST-based stroke education module on knowledge, attitudes, and practices (KAP) among hospitalised stroke patients.
Study Setting and Population
The study will enroll stroke patients admitted to the neurology ward using consecutive sampling. Participants will be adults (≥18 years) with a confirmed diagnosis of acute stroke (ischemic or hemorrhagic) by MRI or CT scan according to WHO criteria. Patients must be clinically stable, cognitively able to participate, and understand Malay or English.
Exclusion criteria include age under 18 years, significant cognitive impairment, severe aphasia precluding participation, medical instability, pre-existing dementia, severe visual or hearing impairments, and expected discharge within 24 hours.
Sample Size
Based on a power of 80%, significance level of 0.05, and expected effect size of 0.5 for knowledge improvement (derived from meta-analytic findings), the minimum required sample needed is 64 participants. To account for 15% potential dropout and enable subgroup analyses, the target recruitment is 120 patients.
Intervention: BEFAST-Based Stroke Education Module
The structured education module is based on ANGELS Initiative International protocols and is delivered during a single 60-minute session per participant. The intervention will use a multi-modal approach:
- Direct health education: One-hour PowerPoint presentation delivered by doctors during admission
- Nurse-led reinforcement: Education by stroke nurses to all patients during admission
- Ward round reinforcement: Daily BEFAST mnemonic reinforcement by doctors and nurses
- Printed materials: Informative pamphlets in the participant's preferred language (Malay or English)
- Visual aids: Awareness posters displayed in the ward and at bedside lockers
- Digital resources: Educational videos
- Post-discharge follow-up: WhatsApp messages reinforcing key messages
Educational content covers:
- Stroke definitions and types (ischemic vs. hemorrhagic)
- BEFAST mnemonic components (Balance disturbance, Eyes/visual disturbance, Facial drooping, Arm weakness, Speech difficulties, Time to call emergency services)
- Modifiable and non-modifiable risk factors
- Appropriate emergency actions with emphasis on the 4.5-hour therapeutic window for thrombolysis
- Preventive measures and lifestyle modifications
Data Collection Instruments
The study will use a validated questionnaire developed from a previous Malaysian stroke awareness study, aligned with Malaysian clinical practice guidelines.
The self-administered questionnaire comprises two parts with "yes"/"no" responses:
Part 1: Sociodemographic characteristics (age, gender, ethnicity, education, employment, marital status) and medical history (smoking, alcohol, diabetes, hypertension, previous heart attack or stroke)
Part 2 (KAP domains):
Knowledge (0-50 points): Organs affected, causes, risk factors, warning signs (BEFAST components), preventability, effects on daily activities
Attitudes (0-4 points): Preferences for conventional, traditional, faith-based, or combined treatment approaches
Actions (0-6 points): Intended emergency responses and time sensitivity of seeking care
Data Collection Timeline
Assessments occur at three time points:
- Pre-intervention: During hospital admission, before any education
- Immediate post-intervention: Immediately following the 60-minute educational session
- One-month follow-up: Telephone interview to assess knowledge retention and behavioural implementation
Statistical Analysis
Analyses will be performed using SPSS version 29.0. Descriptive statistics will summarize baseline characteristics. McNemar's test will compare pre-post changes in individual KAP items. Wilcoxon signed-rank test will compare pre-post KAP domain scores and total scores. Multiple linear regression will examine associations between demographic factors and KAP outcomes. Statistical significance will be set at p < 0.05.
Ethical approval was obtained from the Ethics Committee Involving Human Subjects Universiti Putra Malaysia (Reference No: JKEUPM-2024-257). Written informed consent will be obtained from all participants before enrolment. All procedures are performed in accordance with the Declaration of Helsinki and Malaysian Good Clinical Practice guidelines.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Selangor
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Serdang, Selangor, 말레이시아, 43400
- Hospital Pengajar Universiti Putra Malaysia/ Hospital Sultan Abdul Aziz Shah UPM
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Over 18 years old
- Diagnosed with acute stroke (either ischemic or hemorrhagic) confirmed via MRI or CT scan according to WHO criteria
- Clinically stable as determined by the attending neurologist using standardized assessment protocols
- Cognitively able to participate
- Able to understand Malay or English language as confirmed through structured communication assessment
Exclusion Criteria:
- Under 18 years of age
- Significant cognitive impairment preventing informed consent
- Severe aphasia precluding meaningful participation as assessed by speech-language pathologists
- Too medically unstable to participate as determined by the clinical team
- Previous documented diagnosis of dementia or other neurodegenerative conditions
- Severe visual or hearing impairments preventing educational material comprehension
- Expected to be discharged within 24 hours of admission
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: BEFAST-Based Stroke Education Intervention
All enrolled stroke patients received a single 60-minute structured stroke education module based on the BEFAST mnemonic (Balance, Eyes, Face, Arm, Speech, Time).
The intervention was delivered during hospital admission using multiple modalities: direct health education by doctors and nurses, PowerPoint presentations, informative pamphlets in Malay or English, ward posters, educational videos, daily BEFAST reinforcement during ward rounds, and follow-up WhatsApp messages after discharge.
Outcomes were assessed pre-intervention, immediately post-intervention, and at one month follow-up.
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A structured, single-session (60-minute) stroke education module delivered to hospitalized stroke patients. The content includes:
Delivery methods:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Total Stroke Knowledge Score
기간: Baseline (pre-intervention) to immediately post-intervention (immediately after the 60-minute education session)
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Total knowledge score measured by a validated 50-point questionnaire assessing stroke definition, causes, risk factors, warning signs (BEFAST components), preventability, and effects on daily activities.
Higher scores indicate better knowledge.
The score range is 0-50.
The primary analysis compares pre-intervention and immediate post-intervention scores using Wilcoxon signed-rank test.
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Baseline (pre-intervention) to immediately post-intervention (immediately after the 60-minute education session)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in action and attitude scores
기간: Baseline, immediately post-intervention, and 1 month follow-up
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Action score (0-6 points; higher = better emergency responses) and attitude score (0-4 points; higher = stronger preference for medical treatment).
Measured by validated questionnaire.
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Baseline, immediately post-intervention, and 1 month follow-up
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Knowledge retention and BEFAST component recognition at one month
기간: Baseline and 1 month follow-up
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Total knowledge score (0-50 points) retention, recognition of each BEFAST warning sign (Balance, Eyes, Face, Arm, Speech, Time), identification of modifiable risk factors (hypertension, diabetes, smoking, etc.), and reduction in inappropriate emergency actions (pharmacy visits, traditional healing, spiritual healing).
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Baseline and 1 month follow-up
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HSAASStrokeEducation
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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뇌졸중에 대한 임상 시험
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Institut National de la Santé Et de la Recherche...모병