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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- 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.
- 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:
- Stroke definitions and types (ischemic vs. hemorrhagic)
- BEFAST mnemonic for symptom recognition (Balance disturbance, Eyes/visual disturbance, Facial drooping, Arm weakness, Speech difficulties, Time to call emergency services)
- Modifiable and non-modifiable risk factors for stroke
- Appropriate emergency actions with emphasis on the 4.5-hour therapeutic window for thrombolysis
- Preventive measures and lifestyle modifications
Delivery methods:
- One-hour PowerPoint presentation by doctors during admission
- Direct education by stroke nurses
- Daily BEFAST reinforcement by doctors and nurses during ward rounds
- Informative pamphlets in participant's preferred language (Malay or English)
- Awareness posters in the ward and at bedside lockers
- Educational videos
- Follow-up WhatsApp messages after discharge
| Study group | Role | What they receive |
|---|---|---|
| BEFAST-Based Stroke Education Intervention | Experimental | 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. Receives: Behavioral: BEFAST-Based Stroke Education Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted9 Jun 2026
- Study start1 Sep 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital Pengajar Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07636889
- Acronym / sponsor ID
- HSAASStrokeEducation
- Conditions
- Stroke
- Keywords
- Stroke education, BEFAST, knowledge, attitude, practice, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hospital Pengajar Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| BEFAST-Based Stroke Education Intervention | Experimental | Behavioral: BEFAST-Based Stroke Education ModuleAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEFAST-Based Stroke Education ModuleA 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 | Behavioural | BEFAST-Based Stroke Education Intervention |
Primary outcome
Change in Total Stroke Knowledge Score
Time frame: 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.
2 secondary outcomes
Change in action and attitude scores
Time frame: Baseline, immediately post-intervention, and 1 month follow-up
Knowledge retention and BEFAST component recognition at one month
Time frame: Baseline and 1 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.