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

BACKGROUNDHealth 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. METHODSA 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. RESULTSWe 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 patients 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). CONCLUSIONSThe 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. CLINICAL TRIAL REGISTRATIONhttps://clinicaltrials.gov/ct2/show/NCT05520034.