Reduction of Recurrence of Stroke by Nurse-led Education in Bangladesh
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
1 other identifier
interventional
432
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Oct 2022
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
October 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedSeptember 15, 2025
September 1, 2025
1.4 years
August 23, 2022
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of the recurrence rate of stroke.
Compare the recurrence rate of stroke between the intervention group and the control group
12 months
Secondary Outcomes (8)
Change of the number of adverse events
12 months
Change in values of blood pressure level
12 months
Change in value of HbA1c
12 months
Change in non-HDL cholesterol
12 months
Changes in scores in knowledge related to stroke
12 months
- +3 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALThe participants provided health education regarding understanding stroke and the risk factors, lifestyle changes related to modifiable factors, (self)-monitoring of daily blood pressure (BP), and compliance with medication and hospital/clinic visits. At 6 and 12 months RA nurses collected data and samples for lab tests from the patient's house if the patient cannot come to NINSH for any reason. We provided all the patients with lab test costs and transportation fees if they visited any healthcare center for any lab test related to our study.
Control Group
NO INTERVENTIONThe participants received a one-time telephone call from research nurses every month to keep in contact (telephone calls did not include health education). At 6 and 12 months RA nurses collected data and samples for lab tests from the patient's house if the patient cannot come to NINSH for any reason. We provided all the patients with lab test costs and transportation fees if they visited any healthcare center for any lab test related to our study.
Interventions
The participants received a 45mins, face-to-face group health education after enrollment and during the 6th month by a RA nurse. Participants received the same health education over the phone call if the patient and family caregiver could not come for any reason. They also received 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)
Eligibility Criteria
You may qualify if:
- Who will provide written consent \& willing to participate in the study
You may not qualify if:
- Who has stroke with the recurrence
- Stroke subtype: caused by genetic problems or injury/accident
- Patients with multi-organ failure or terminal stage
- Participation in other clinical trials
- Unwillingness to participate in the study
- Not having a mobile phone at home
- mRS 5
- Who is not living with the patient
- Who is under 18 years old
- Who is mentally unstable and/or cognitively impaired (diagnosed cases)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Neurosciences & Hospital
Dhaka, 1207, Bangladesh
Related Publications (5)
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.
PMID: 26445548BACKGROUNDKatan 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.
PMID: 29791947BACKGROUNDGBD 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.
PMID: 34487721BACKGROUNDAfrin M, Huq KATME, Khan SU, Das SC, Chowdhury MSJH, Fukuoka Y, Fukushima Y, Moriyama M. Effectiveness of a Health Education Program to Reduce Recurrence of Stroke by Controlling Modifiable Risk Factors in a Specialized Hospital in Bangladesh: Randomized Controlled Trial. JMIR Public Health Surveill. 2025 May 27;11:e72233. doi: 10.2196/72233.
PMID: 40424617DERIVEDAfrin M, Khan SU, Das SC, Huq KATME, Moriyama M. Effectiveness of a Health Education Program for Patients Who Had a Stroke and Their Caregivers by Controlling Modifiable Risk Factors to Reduce Stroke Recurrence in a Tertiary Hospital in Bangladesh: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 15;12:e51178. doi: 10.2196/51178.
PMID: 38100172DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KATM Ehsanul Huq, PhD
Hiroshima University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Two-arm open-label study
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctoral Researcher
Study Record Dates
First Submitted
August 23, 2022
First Posted
August 29, 2022
Study Start
October 2, 2022
Primary Completion
February 28, 2024
Study Completion
March 30, 2026
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share