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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520034
• Other study ID #: 151
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: October 2023
• Source: Hiroshima University
• Contact: Mahabuba Afrin, PhD
• Phone: +8108057903018
• Email: mahabuba.a32[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: March 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For patient

1. Who will be discharged from NINSH to home or who will visit at NINSH right after getting stroke

2. First-time stroke

3. All types of strokes, except subarachnoid haemorrhage

4. modified Rankin Scale (0 - 4)

5. Stroke patient who is 18 years old and above

6. Both males & females

7. Who will provide written consent & willing to participate in the study

For family caregivers

1. Primary caregivers irrespective of sex and aged 18 years old and above, living with the patient who take care of an above patient and who meets all of the inclusion criteria (will be decided by one person)

2. Who will provide written consent & willing to participate in the study

Exclusion Criteria:

Exclusion criteria of patient

1. Who has stroke with the recurrence

2. Stroke subtype: caused by genetic problems or injury/accident

3. Patients with multi-organ failure or terminal stage

4. Participation in other clinical trials

5. Unwillingness to participate in the study

6. Not having a mobile phone at home

7. mRS 5

Exclusion criteria of caregiver

1. Who is not living with the patient

2. Who is under 18 years old

3. Who is mentally unstable and/or cognitively impaired (diagnosed cases)

Related Conditions & MeSH terms

• Recurrence
• Stroke

Intervention

Behavioral:
• Health Education
The participants will receive a 45mins, face-to-face group health education before discharge and during the 6th month by a nurse and a physiotherapist. Participants will be received refresher health education over the phone call , if the patient and family caregiver cannot come for any reason. They will also receive a digital BP machine, a salt-measurement spoon, a medication box, and a recording notebook for monitoring. The intervention group receives health education above and reminder telephone calls provided by research assistant nurses every month (1st month to 3rd month: twice a month, and 4th month to 12th month: once a month)

Locations

Country	Name	City	State
Bangladesh	National Institute of Neurosciences & Hospital	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Hiroshima University	National Institute of Neuro Sciences & Hospital, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (3)

Clarke DJ, Forster A. Improving post-stroke recovery: the role of the multidisciplinary health care team. J Multidiscip Healthc. 2015 Sep 22;8:433-42. doi: 10.2147/JMDH.S68764. eCollection 2015. — View Citation

GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3. — View Citation

Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the recurrence rate of stroke.	Compare the recurrence rate of stroke between the intervention group and the control group	12 months
Secondary	Change of the number of adverse events	Compare the number of all causes of death, and cardiovascular events between the intervention group and the control group. The adverse event refers that all cases that need to be diagnosed: for example, new onset of acute myocardial infarction (AMI) and unstable angina, heart failure (with hospitalization), PAD (peripheral arterial disease: hospitalization)	12 months
Secondary	Change in values of blood pressure level	Compare value of blood pressure (mmHg) between the intervention group and the control group.	12 months
Secondary	Change in value of HbA1c	Compare value of HbA1c (%) between the intervention group and the control group.	12 months
Secondary	Change in non-HDL cholesterol	Compare value of non-HDL cholesterol (mg/dl) (total cholesterol minus HDL cholesterol) between the intervention group and the control group.	12 months
Secondary	Changes in scores in knowledge related to stroke	Compare scores in knowledge related to stroke (the researcher-developed "Knowledge questionnaire of stroke") between the intervention group and the control group. The questionnaire consists of 10 items with "No/Wrong answer", "Yes/Correct answer", and "Don't know" answers. The score ranges from 0-20, and a higher score indicates having better knowledge.	12 months
Secondary	Changes in scores in lifestyle behavior related to stroke	Compare scores in lifestyle behavior related to stroke (the researcher-developed "Lifestyle behavior questionnaire related to stroke") between the intervention group and the control group. The questionnaire consists of 14 items (6 items will not be counted) with a Likert scale with the frequency of behaviors. The score ranges from 0-37, and a higher score indicates having better lifestyle behavior.	12 months
Secondary	Changes in scores in medication adherence	Compare scores of behavior changes in medication adherence measured by a "Medication adherence related questionnaire" between the intervention group and the control group.; The questionnaire consists of 4 items with "Yes=0" and "No=1" answers. The score ranges from 0-4, and a higher score indicates better compliance.	12 months
Secondary	Changes in scores in QoL	Compare behavior changes in QoL measured by a "WHOQOL- BREF Bangla Version-2 items)" between the intervention group and the control group. Each item scores from 1 (very poor/very dissatisfied) to 5 (very good/very satisfied), and ranges (mean of 2 items) from 1 to 5, a higher mean indicates a better QoL.	12 months