NCT07636889

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

May 25, 2026

Last Update Submit

June 5, 2026

Conditions

Keywords

Stroke educationBEFASTknowledgeattitudepracticepatient education

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • Change in action and attitude scores

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

  • Knowledge retention and BEFAST component recognition at one month

    Baseline and 1 month follow-up

Study Arms (1)

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.

Behavioral: BEFAST-Based Stroke Education Module

Interventions

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

BEFAST-Based Stroke Education Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Pengajar Universiti Putra Malaysia/ Hospital Sultan Abdul Aziz Shah UPM

Serdang, Selangor, 43400, Malaysia

Location

MeSH Terms

Conditions

StrokeBehavior

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 9, 2026

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations