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StrokeNCT07636889

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

A study testing BEFAST-Based Stroke Education Module in people with Stroke, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
BEFAST-Based Stroke Education Module
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteMalaysia
Study dates
1 Sep 2024to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Hospital Pengajar Universiti Putra Malaysia/ Hospital Sultan Abdul Aziz Shah UPM

    Serdang, Selangor, 43400

Other trials in Malaysia

About this 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.

Read the detailed description

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.

Conditions
Stroke
Being tested
BEFAST-Based Stroke Education Module
Keywords
Stroke education, BEFAST, knowledge, attitude, practice, patient education
Medical subject headings
Stroke, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEFAST-Based Stroke Education ModuleBehavioural

    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
Study groups in NCT07636889
Study groupRoleWhat they receive
BEFAST-Based Stroke Education InterventionExperimentalAll 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.
Receives: Behavioral: BEFAST-Based Stroke Education Module

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Total Stroke Knowledge Score

    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.

    Measured: Baseline (pre-intervention) to immediately post-intervention (immediately after the 60-minute education session)

Secondary outcomes (2)
  1. Change in action and attitude scores

    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.

    Measured: Baseline, immediately post-intervention, and 1 month follow-up

  2. Knowledge retention and BEFAST component recognition at one month

    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).

    Measured: Baseline and 1 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start1 Sep 2024
  3. Primary completion1 Sep 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Participants received a single 60-minute BEFAST-based stroke education module during hospital admission. Outcomes were assessed before the intervention, immediately after, and at one month follow-up. No control group was used.
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07636889
Sponsor's protocol ID
HSAASStrokeEducation
Status last verified
Jun 2026
First submitted
25 May 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing BEFAST-Based Stroke Education Module in people with Stroke, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total Stroke Knowledge Score (time frame: Baseline (pre-intervention) to immediately post-intervention (immediately after the 60-minute education session)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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