A Randomised Controlled Study to Compare the Effects of Standardised Care Plus Conventional Care Versus Conventional Care Only on the Outcomes of Stroke Survivors (HIV+ and HIV-) and Their Family Caregivers in Harare and Chitungwiza
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- Quality of life of stroke patients and family caregivers using the Euroqol - Five Dimensions (EQ-5D)
研究概览
简要总结
The burden of stroke has continued to increase in Zimbabwe in the last 3 decades. resulting in increased burden of care to family caregivers. Caregivers who had cared for survivors for periods exceeding 3 months indicated desire to be taught about basic care before they were discharged from hospital and a curriculum of training based on a targeted needs analysis was developed. One arm of the study will receive caregivers training as the intervention and the other arm will be the control. The outcome of both the caregivers and survivors will be compared based on selected tools. Data will be collected at baseline (at most 2 weeks after suffering a stroke) the participants will be followed up at 3 and 12 months post stroke.
详细描述
SUMMARY
TITLE A randomised controlled study to compare the effects of standardised care plus conventional care versus conventional care only on the outcomes of stroke survivors (HIV+ and HIV-) and family caregivers in Harare and Chitungwiza.
RESEARCH QUESTION 1. What are the effects of a standardised care plus conventional care versus conventional care only on the outcomes of stroke survivors and family caregivers in Harare and Chitungwiza?
RATIONALE FOR RESEARCH
Randomising the participants (people that have survived a stroke and their family caregivers) into trained and untrained groups and following them up using standardised measurement tools will highlight the effect that training has on the quality of life of the stroke survivors and their caregivers as well as function and community reintegration of survivors and burden of care among the caregivers. It is expected this will provide evidence for the need to provide an intervention program that will support family caregivers and improve the outcomes of both. It is against this background that this study aims to determine the effect that a standardised caregiver training program has on the outcomes and quality of life of the caregivers and stroke survivors in Harare and Chitungwiza.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •List of Inclusion Criteria:
- •First ever confirmed clinical diagnosis of stroke. All patients diagnosed of stroke and who are 18 years and above will be recruited.
- •The stroke patients are likely to return home with residual disability
- •Both males and females are eligible and should be residing in Harare and Chitungwiza communities during the period of study.
- •Stroke survivors must have a family caregiver
- •HIV status may or may not be known
- •Care giver is willing and able to provide support after discharge
- •Fulfills the research definition of a family care giver
排除标准
- •Stroke patients with other diagnoses of neurological origin and a previous neurological disorder and orthopedic conditions that hamper treatment are not eligible to participate.
- •Patients with a history of psychiatric illness will be excluded.
研究组 & 干预措施
Intervention using standardised care
Caregiver training /standardised care: where the participants (caregivers)s are trained on caring for relative who has survived a stroke once only for one hour using a developed curriculum.
Plus Conventional care: where the participants continue to receive the usual care as offered in protocols for treatment of stroke in Zimbabwe.
干预措施: Caregiver training (Other)
Control
No training offered to caregivers but conventional care only where the people who have survived a stroke receive the usual care as offered in protocols for treatment of stroke in Zimbabwe.
结局指标
主要结局
Quality of life of stroke patients and family caregivers using the Euroqol - Five Dimensions (EQ-5D)
时间窗: Change from baseline EQ-5D at 12 months
Health related quality of life tested using the Euroqol - Five Dimensions (EQ-5D)
次要结局
- burden of care of family caregivers(Change from baseline Caregiver Strain Index (CSI) at 12 months)
- Functional outcome of stroke patients(Change from baseline Functional Independence Measure (FIM) at 12months)
- Community reintegration of stroke patients(At 3 months and 12 months)
研究者
Farayi Kaseke
Research Director
University of Zimbabwe