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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hiroshima University
- Enrollment
- 432
- Locations
- 1
- Primary Endpoint
- Change of the recurrence rate of stroke.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
Two-arm open-label study
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For patient
- •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)
- •Stroke patient who is 18 years old and above
- •Both males & females
- •Who provided written consent & willing to participate in the study
- •For family caregivers
- •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)
- •Who will provide written consent & willing to participate in the study
Exclusion Criteria
- •Exclusion criteria of patient
- •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
- •Exclusion criteria of caregiver
- •Who is not living with the patient
- •Who is under 18 years old
- •Who is mentally unstable and/or cognitively impaired (diagnosed cases)
Arms & Interventions
Intervention group
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.
Intervention: Health Education (Behavioral)
Control Group
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.
Outcomes
Primary Outcomes
Change of the recurrence rate of stroke.
Time Frame: 12 months
Compare the recurrence rate of stroke between the intervention group and the control group
Secondary Outcomes
- Changes in scores in lifestyle behavior related to stroke(12 months)
- Changes in scores in QoL(12 months)
- Changes in scores in medication adherence(12 months)
- Change in non-HDL cholesterol(12 months)
- Changes in scores in knowledge related to stroke(12 months)
- 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)
Investigators
Mahabuba Afrin
Doctoral Researcher
Hiroshima University