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临床试验/NCT05520034
NCT05520034招募中不适用

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

Hiroshima University2 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2022年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
432
试验地点
2
主要终点
Change of the recurrence rate of stroke.

研究概览

简要总结

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.

详细描述

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 will be the first stroke patients who are discharged from the National Institute of Neurosciences & Hospital (NINSH) and the family caregivers of the patients. The written informed consent will be 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 will provide consent.

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

Two-arm open-label study

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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)

结局指标

主要结局

Change of the recurrence rate of stroke.

时间窗: 12 months

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

次要结局

  • 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)
  • Changes in scores in lifestyle behavior related to stroke(12 months)
  • Changes in scores in QoL(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahabuba Afrin

Doctoral Researcher

Hiroshima University

研究点 (2)

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