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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. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

112

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Total Stroke Knowledge Score
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in action and attitude scores
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. September 2024

Primärer Abschluss (Tatsächlich)

1. September 2025

Studienabschluss (Tatsächlich)

1. September 2025

Studienanmeldedaten

Zuerst eingereicht

25. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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