Effects of Health Education to Reduce Stroke Recurrence by Controlling Modifiable Factors: A Randomized Controlled Trial

ABSTRACT

BACKGROUND Health education could be an effective measure to prevent stroke recurrence; however, the evidence is still ambiguous. The aim of this study was to evaluate the effectiveness of a health education program among stroke patients and their family caregivers to reduce stroke recurrence.

METHODS A parallel (1:1), open-label, prospective randomized controlled trial was conducted at the National Institute of Neuroscience & Hospital in Bangladesh between October 2022 and March 2024. We enrolled stroke patients who were discharged from the inpatient department or attended as an outpatient of the hospital. The primary endpoint was the recurrence rate of stroke within 12 months of intervention. The secondary endpoints were the rate of all adverse events related to stroke that occurred within 12 months of follow-up visits.

RESULTS We analyzed data from 432 patients (216 in each group). We found recurrence was 14 (6.5%) in the IG and 8 (3.7%) in the CG after 28 days of first-stroke attack, and the difference was not significant (p=0.189). We observed stroke-related adverse events 116 (26.9%) (25.0% in IG and 28.7% in CG, p=0.294) including death 95 (22.0%) (18.1% in IG and 25.9% in CG, p=0.041) during 12-month period. Even though stroke patient’s medication adherence was significantly improved at 6-month and 12-month after intervention in IG (p<0.001 and p=0.002, respectively), all events and all causes of death were not significant after adjusted by the severity of stroke (mRS) (p=0.933, p=0.341, respectively).

CONCLUSIONS The findings of this newly approached intervention can be used as the most reliable evidence for epidemiological figures for Bangladesh. Health education could reduce death and enhance medication adherence significantly among stroke patients. This study results suggest the importance of structuring the acute care system and health education programs to integrate into the health system for the management of stroke. However, an accurate diagnostic and follow-up system is crucial.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT05520034

Funding Statement

The study was supported by the research grant from Hiroshima University, Japan

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was approved by the Institutional Review Board and the Ethical Review Board of the NINSH (IRB/ NINSH/2022/151).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

The data supporting the findings of this study are available from the corresponding author upon reasonable request.

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