NCT05520034

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

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
432

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 2, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

August 23, 2022

Last Update Submit

September 8, 2025

Conditions

Keywords

StrokeCaregiverRecurrence of strokeHealth educationBangladesh

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

EXPERIMENTAL

The 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.

Behavioral: Health Education

Control Group

NO INTERVENTION

The 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)

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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: 26445548BACKGROUND
  • 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.

    PMID: 29791947BACKGROUND
  • 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.

    PMID: 34487721BACKGROUND
  • Afrin 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.

  • Afrin 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.

MeSH Terms

Conditions

StrokeHealth Education

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • KATM Ehsanul Huq, PhD

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahabuba Afrin, PhD

CONTACT

Dr.Subir Chandra Das, MBBS

CONTACT

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
Model Details: Randomized control trial (RCT) study
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

Locations