Educational Tool for Stroke Prevention

(BEAT STROKE Trial)

Overseen By Diana Ayan, Pharm MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

2400 Participants Needed

Trial Summary

What is the purpose of this trial?

The WSO Brain and hEart globAl iniTiative - STROKE (BEAT-STROKE) is a cluster randomized controlled trial, testing whether an educational and implementation Neurocardiology tool can improve adherence to best practice recommendations for secondary stroke prevention of cardioembolic strokes, as defined by the WSO Systematic Review and Synthesis of Global Stroke Guidelines or more recent high-quality evidence published after the last stroke guidelines1

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on educational tools for stroke prevention, so it's best to ask the trial coordinators for more details.

What data supports the effectiveness of the treatment Neurocardiology Tool for stroke prevention?

Educational programs for stroke patients, like the one described in the research, have been shown to improve patient knowledge, medication adherence, and blood pressure control, which are important for preventing future strokes. This suggests that educational tools, such as the Neurocardiology Tool, could be effective in helping patients manage their health better after a stroke. ^{1 2 3 4 5}

Is the Educational Tool for Stroke Prevention safe for humans?

There is no specific safety data available for the Educational Tool for Stroke Prevention or its other names like Neurocardiology Tool. However, general studies on stroke patients show that adverse events (unintended harm from medical care) are common, but the specific safety of this tool has not been evaluated in the provided research. ^{6 7 8 9 10}

How is the Neurocardiology Tool treatment different from other stroke prevention treatments?

The Neurocardiology Tool is unique because it focuses on using educational technologies to improve patient understanding and compliance with stroke prevention strategies, unlike traditional treatments that may not emphasize patient education as much. This approach includes multimodal education through SMS, print, and audio-visual materials to help patients manage their risk factors more effectively. ^{11 12 13 14 15}

Eligibility Criteria

The WSO BEAT STROKE trial is for individuals who have had a stroke, specifically those with conditions like Patent Foramen Ovale or Atrial Fibrillation. It aims to see if following certain guidelines can prevent another stroke.

Inclusion Criteria

I have had a stroke or a transient ischemic attack.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Sites receive the educational and implementation Neurocardiology tool to improve adherence to best practice recommendations for secondary stroke prevention

6 months

Follow-up

Participants are monitored for major adverse cardiovascular events and Neurocardiology Score improvements

12 months

Treatment Details

Interventions

• Neurocardiology Tool

Trial Overview This study tests an educational tool designed to help doctors stick to the best practices for preventing strokes that come from heart-related issues. Some participants will use this tool, while others won't, to compare outcomes.

Participant Groups

Group I: Intervention arm Active Control 1 Intervention

Sites randomized in this arm will receive the educational and implementation Neurocardiology tool with the aim of improving adherence to best practice recommendations for secondary stroke prevention of cardioembolic strokes, as defined by the WSO Systematic Review and Synthesis of Global Stroke Guidelines or more recent high-quality evidence published after the last stroke guidelines.

Group II: No intervention Placebo Group 1 Intervention

This group will not receive any of the educational and/or implementation Neurocardiology until the data collection is completed.

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

W.L.Gore & Associates

Industry Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

An educational program for hypertensive patients after a stroke significantly improved their knowledge about their condition, with correct response rates increasing from 77.9% to 94.1% after the intervention.

The program also led to better medication adherence and more frequent self-measurement of blood pressure, indicating that education can play a crucial role in managing health post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a hypertension-based patient education program in a stroke center. Ben Nasr, N., Rouault, A., Cornillet, N., et al.[2021]

In a study of 468 stroke patients, severe adverse events were found to be significantly more common in those who died compared to those who were discharged, with 76.5% of events occurring in deceased patients.

Major adverse events, particularly those related to medical procedures and nursing activities, were strongly associated with death, highlighting the need for improved safety measures in stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and death in stroke patients admitted to the emergency department of a tertiary university hospital. Daud-Gallotti, R., Dutilh Novaes, HM., Lorenzi, MC., et al.[2019]

A collaborative calibration process among teams from 4 dental institutions led to an 82.2% agreement rate in identifying adverse events (AEs) in dental care, highlighting the importance of teamwork in improving patient safety.

The study found that categorizing the severity of AEs had a higher agreement rate (82.2%) compared to identifying the events themselves, suggesting that training and consensus-building are crucial for accurately assessing AEs in dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Consensus for a Shared Definition of Adverse Events: A Case Study in the Profession of Dentistry. Franklin, A., Kalenderian, E., Hebballi, N., et al.[2023]

In a study of 150 stroke patients, 170 adverse events (AEs) and no-harm incidents were identified, affecting over half of the patients, highlighting the high incidence of patient harm in stroke care.

The most common AEs included ischemic strokes and urinary tract infections, with a significant portion of medication events being preventable, indicating a need for improved safety measures in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. Nowak, B., Schwendimann, R., Lyrer, P., et al.[2022]

The study developed the IschAEmic Stroke Calculator, an online tool that predicts the incidence of adverse events (AEs) in acute stroke trials based on patient characteristics, using data from the Virtual International Stroke Trials Archive (VISTA).

This calculator identifies 48 common AEs and allows researchers to compare predicted incidences with observed data, aiding in the interpretation of trial safety and potentially guiding preventive measures in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Tool to Improve Stratification of Adverse Events in Stroke Clinical Trials. Hesse, K., MacIsaac, RL., Abdul-Rahim, AH., et al.[2021]

A comprehensive multilingual patient education package, including SMS, videos, and workbooks, was developed to improve medication compliance and reduce stroke risk factors in patients with recent strokes, involving input from 355 stakeholders.

The educational materials were found to be highly understandable, with an average assessment score of over 95%, and no implementation issues were reported by patients or research coordinators after one month, indicating readiness for further testing in a randomized control trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Development of Structured Semi-interactive Stroke Prevention Package for Secondary Stroke Prevention. Kate, MP., Verma, SJ., Arora, D., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a hypertension-based patient education program in a stroke center. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Implementation of the comprehensive assessment toolbox for stroke in a medical system. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Use of a patient-centred educational exchange (PCEE) to improve patient's self-management of medicines after a stroke: a randomised controlled trial study protocol. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effect of recommended positioning on stroke outcome at six months: a randomized controlled trial. [2017]

5. China pubmed.ncbi.nlm.nih.gov

Effectiveness of an educational program on improving healthcare providers' knowledge of acute stroke: A randomized block design study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events and death in stroke patients admitted to the emergency department of a tertiary university hospital. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Building Consensus for a Shared Definition of Adverse Events: A Case Study in the Profession of Dentistry. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence of No-Harm Incidents and Adverse Events in Hospitalized Patients with Ischemic Stroke or TIA: A Cohort Study Using Trigger Tool Methodology. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Online Tool to Improve Stratification of Adverse Events in Stroke Clinical Trials. [2021]

10. Austria pubmed.ncbi.nlm.nih.gov

A complication conference for internal quality control at the Neurosurgical Department of the University of Heidelberg. [2019]

11. Brazil pubmed.ncbi.nlm.nih.gov

Educational technologies for health education on stroke: an integrative review. [2022]

12. India pubmed.ncbi.nlm.nih.gov

Systematic Development of Structured Semi-interactive Stroke Prevention Package for Secondary Stroke Prevention. [2022]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

MyRisk_Stroke Calculator: A Personalized Stroke Risk Assessment Tool for the General Population. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Utilising interactive technology for stroke patient education: a systematic review. [2023]

15. Switzerland pubmed.ncbi.nlm.nih.gov

In Search of a Gold Standard Tool for Assessing Knowledge of Stroke: A Systematic Review. [2023]