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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

5 giugno 2026 aggiornato da: Hospital Pengajar Universiti Putra Malaysia

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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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:

  1. Direct health education: One-hour PowerPoint presentation delivered by doctors during admission
  2. Nurse-led reinforcement: Education by stroke nurses to all patients during admission
  3. Ward round reinforcement: Daily BEFAST mnemonic reinforcement by doctors and nurses
  4. Printed materials: Informative pamphlets in the participant's preferred language (Malay or English)
  5. Visual aids: Awareness posters displayed in the ward and at bedside lockers
  6. Digital resources: Educational videos
  7. Post-discharge follow-up: WhatsApp messages reinforcing key messages

Educational content covers:

  1. Stroke definitions and types (ischemic vs. hemorrhagic)
  2. BEFAST mnemonic components (Balance disturbance, Eyes/visual disturbance, Facial drooping, Arm weakness, Speech difficulties, Time to call emergency services)
  3. Modifiable and non-modifiable risk factors
  4. Appropriate emergency actions with emphasis on the 4.5-hour therapeutic window for thrombolysis
  5. 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:

  1. Pre-intervention: During hospital admission, before any education
  2. Immediate post-intervention: Immediately following the 60-minute educational session
  3. 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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

112

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • Hospital Pengajar Universiti Putra Malaysia/ Hospital Sultan Abdul Aziz Shah UPM

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Over 18 years old
  2. Diagnosed with acute stroke (either ischemic or hemorrhagic) confirmed via MRI or CT scan according to WHO criteria
  3. Clinically stable as determined by the attending neurologist using standardized assessment protocols
  4. Cognitively able to participate
  5. Able to understand Malay or English language as confirmed through structured communication assessment

Exclusion Criteria:

  1. Under 18 years of age
  2. Significant cognitive impairment preventing informed consent
  3. Severe aphasia precluding meaningful participation as assessed by speech-language pathologists
  4. Too medically unstable to participate as determined by the clinical team
  5. Previous documented diagnosis of dementia or other neurodegenerative conditions
  6. Severe visual or hearing impairments preventing educational material comprehension
  7. Expected to be discharged within 24 hours of admission

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

A structured, single-session (60-minute) stroke education module delivered to hospitalized stroke patients. The content includes:

  1. Stroke definitions and types (ischemic vs. hemorrhagic)
  2. BEFAST mnemonic for symptom recognition (Balance disturbance, Eyes/visual disturbance, Facial drooping, Arm weakness, Speech difficulties, Time to call emergency services)
  3. Modifiable and non-modifiable risk factors for stroke
  4. Appropriate emergency actions with emphasis on the 4.5-hour therapeutic window for thrombolysis
  5. Preventive measures and lifestyle modifications

Delivery methods:

  1. One-hour PowerPoint presentation by doctors during admission
  2. Direct education by stroke nurses
  3. Daily BEFAST reinforcement by doctors and nurses during ward rounds
  4. Informative pamphlets in participant's preferred language (Malay or English)
  5. Awareness posters in the ward and at bedside lockers
  6. Educational videos
  7. Follow-up WhatsApp messages after discharge

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Total Stroke Knowledge Score
Lasso di tempo: Baseline (pre-intervention) to immediately post-intervention (immediately after the 60-minute education session)
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.
Baseline (pre-intervention) to immediately post-intervention (immediately after the 60-minute education session)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in action and attitude scores
Lasso di tempo: Baseline, immediately post-intervention, and 1 month follow-up
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.
Baseline, immediately post-intervention, and 1 month follow-up
Knowledge retention and BEFAST component recognition at one month
Lasso di tempo: Baseline and 1 month follow-up
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).
Baseline and 1 month follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2024

Completamento primario (Effettivo)

1 settembre 2025

Completamento dello studio (Effettivo)

1 settembre 2025

Date di iscrizione allo studio

Primo inviato

25 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data (IPD) will not be shared publicly due to participant confidentiality and ethical restrictions approved by the Universiti Putra Malaysia Ethics Committee. The informed consent obtained from participants did not include provisions for public data sharing. While data may be available from the corresponding author upon reasonable request, no formal IPD sharing plan exists.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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