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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHiroshima University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Who was discharged from NINSH to home or who visited NINSH right after getting a stroke

First-time stroke

All types of strokes, except subarachnoid haemorrhage

modified Rankin Scale (0 - 4)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Health Education

    Behavioral

    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)

Treatment groups

432 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change of the recurrence rate of stroke.

Compare the recurrence rate of stroke between the intervention group and the control group

Time frame
12 months

Secondary outcomes

1

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)

Time frame
12 months
2

Change in values of blood pressure level

Compare value of blood pressure (mmHg) between the intervention group and the control group.

Time frame
12 months
3

Change in value of HbA1c

Compare value of HbA1c (%) between the intervention group and the control group.

Time frame
12 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hiroshima University

Lead sponsor

National Institute of Neuro Sciences & Hospital, Bangladesh

Collaborator

Source ClinicalTrials.gov
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