Clinical trial NCT05520034: Reduction of Recurrence of Stroke by Nurse-led Education in Bangladesh
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Caregiver
Recurrence of stroke
Health education
Bangladesh
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: National Institute of Neuro Sciences & Hospital, Bangladesh
First posted: 2022-08-29
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial (RCT) study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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 were the first stroke patients who were discharged from the National Institute of Neurosciences \& Hospital (NINSH) and the family caregivers of the patients. Written informed consent is 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 provided consent.

At baseline, blood specimens such as blood total cholesterol, HDL-cholesterol, HbA1c, and diagnosis including adverse events and blood pressure measurement data were 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 took the baseline data through the interview. The raw data is stored and locked in secured places in NINSH.

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

The sample size was 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) were conducted. Descriptive analysis was 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 was employed to compare the two groups where appropriate. For secondary endpoints, after adjusting for confounding variables such as age, an analysis of covariance (ANCOVA) was used to assess the effect of the intervention on the outcomes. To compensate for missing data, the last observation carried forward was 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 checked the collected data on the same day using a field-tested methodology. Detected errors were corrected immediately at the field site. The findings of the quality control team are considered for necessary corrections if any major discrepancies are found.

Eligibility criteria: For patient

1. Who was discharged from NINSH to home or who visited NINSH right after getting a 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 provided 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)

Primary outcomes:
measure: Change of the recurrence rate of stroke.
timeFrame: 12 months
Secondary outcomes:
measure: Change of the number of adverse events
timeFrame: 12 months
measure: Change in values of blood pressure level
timeFrame: 12 months
measure: Change in value of HbA1c
timeFrame: 12 months
measure: Change in non-HDL cholesterol
timeFrame: 12 months
measure: Changes in scores in knowledge related to stroke
timeFrame: 12 months
measure: Changes in scores in lifestyle behavior related to stroke
timeFrame: 12 months
measure: Changes in scores in medication adherence
timeFrame: 12 months
measure: Changes in scores in QoL
timeFrame: 12 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: National Institute of Neurosciences & Hospital
Study officials:
affiliation: Hiroshima University
name: KATM Ehsanul Huq, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.