Reduction of Recurrence of Stroke by Nurse-led Education in Bangladesh

Stroke Clinical Trial

Official title: Effectiveness of Health Education Program Among Patients & Family Caregivers on Modifiable Risk Factors mRS 0 to 4 to Reduce Recurrence of Stroke After Discharge From a Tertiary Hospital in Bangladesh

Status Recruiting

Clinical Trial Summary

Stroke is a major public issue that can be occurred a patient with severe and unbearable disability for a long time. Recurrence of stroke is increasing due to a lack of knowledge and compliance with treatment regarding the modifiable risk factors of stroke and behavioral and lifestyle changes. Nurse-led health education with (self) monitoring of modifiable risk factors and behaviors can be an effective way to create knowledge about the behavioral changes in stroke patients.

The investigators hypothesized that health education among first stroke patients and their family caregivers could reduce the stroke recurrence rate by controlling modifiable risk factors compared to the first stroke patients without health education.

Clinical Trial Description

In Bangladesh, the top cause of death per 100,000 population for both sexes aged all ages in 2019 is stroke. About 79.9 percent of the total patients were suffering from ischemic stroke, and 15.7 percent and 4.6 percent were diagnosed with hemorrhagic and subarachnoid hemorrhage respectively. One study found the cumulative recurrence rate was 14.7% at three months, 15.3% at six months, 17.3% at the ninth month, and 20% at one year (n=150).

This study aims to evaluate the effect of health education among first-stroke patients and their family caregivers for reducing the recurrence of stroke. The investigators also assess the number and rate of all adverse events, changes in values of modifiable risk factors, and change scores in knowledge, lifestyle behavior, medication adherence, and QoL.

In this study, participants will be the first stroke patients who are discharged from the National Institute of Neurosciences & Hospital (NINSH) and the family caregivers of the patients. The written informed consent will be received from the patient when the patient is the main person of self-management of recurrence prevention, if the patient cannot give consent by disability, his/her family caregiver will provide consent.

At baseline, blood specimens such as blood total cholesterol, HDL-cholesterol, HbA1c, and diagnosis including adverse events and blood pressure measurement data will be obtained from the hospital records/patient's chart.

At first, the research assistant (RA) nurse should confirm the written consent form for the participants. Then, the RA nurse will take the baseline data through the interview. The raw data will be stored and locked in secured places in NINSH.

Confidentiality of data is of utmost importance; therefore, every effort will be made to safeguard the identity of participants and protect subject privacy. All hard copies of data will be stored under lock and kept in the NINSH.

The sample size is based on the calculation of a 10% reduction in recurrence rate compared with the control group with a statistical power of 80% at α= 0.05 (2-tailed). Considering the dropout rate of 10%, the final sample size is 432 (2 arms).

To compare the outcomes of the Intervention Group and Control Group, an intention-to-treat (ITT) analysis and a full analysis set (FAN) will be conducted. Descriptive analysis will be done to assess the baseline data. For categorical data, the chi-square (X2) test, and for continuous variables, the t-test, or Mann-Whitney U test will be employed to compare the two groups where appropriate. For secondary endpoints, after adjusting for confounding variables such as age, an analysis of covariance (ANCOVA) will be used to assess the effect of the intervention on the outcomes. To compensate for missing data, the last observation carried forward will be measured. The significance level will be set at P=0.05. Data will be analyzed using SPSS (version 26.0; IBM Corp).

In 5% of the study participants, the quality control team independently will check the collected data on the same day using a field-tested methodology. Detected errors will be corrected immediately at the field site. The findings of the quality control team will be considered for necessary corrections if any major discrepancies are found. ;

Related Conditions & MeSH terms

• Recurrence
• Stroke

• NCT number: NCT05520034
• Study type: Interventional
• Source: Hiroshima University
• Contact: Mahabuba Afrin, PhD
• Phone: +8108057903018
• Email: mahabuba.a32@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2022
• Completion date: March 30, 2024