The Effectiveness of the Adapted Bridge's Self-management Programme in South African Community-dwelling Stroke Survivors: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 主要终点
- Stroke Self-Efficacy Questionnaire(SSEQ):
研究概览
简要总结
The effectiveness of the adapted Bridge's self-management programme in South African community-dwelling stroke survivors: A randomized controlled trial with two arms will be used, with the intervention group receiving self-management sessions delivered by experienced therapists and usual care and control group will only receive usual care which includes a information booklet.
详细描述
This study aim to determine the effectiveness of the Adapted bridges self-management intervention on South African stroke patients' functional activity, self-efficacy, and participation. Method: This experimental study will make use of a randomized controlled design (RCT), consisting of one hundred and sixty eight stroke survivors recruited from different health care facilities within the Cape Metropolitan area. The study participants will be divided randomly into two groups, with one receiving the intervention - the experimental group - and the other receiving an educational booklet - the control group. Participants will be assessed at baseline, immediately post-intervention (six weeks), three and sixth-month post intervention, using standardized outcome measures (both subjective outcome measures and objective clinical tools). Ethical clearance and permission to conduct the study will be obtained and patient information will be kept confidential. Analyses will be conducted using descriptive statistics of frequencies and percentages for categorical variables and mean and standard deviation for continuous variables. Given the assumptions of equal variance, a two-way full factorial ANOVA will be computed in order to assess interaction between groups and intervention type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double-blinded, participant and assessor blinded, randomised trial.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having a first ever stroke, by a physician, based on the WHO (1988) definition of stroke which is "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin"; ≥18 years of age; of sufficient cognition to participate: having a score of ≥24 points on mini-mental state examination (placing participants at matched mental status) ; are medically stable and; and are within the sub-acute to chronic phase of their rehabilitation (10 weeks to 6-months post stroke).
排除标准
- •Participants will be excluded if they have serious medical conditions such as HIV/AIDS or TB, which could additionally affect the outcomes evaluated in this study. Participants with depression, having recurrent stroke, still receiving in inpatient rehabilitation, with cognitive or receptive language difficulties and are unable to comprehend the intervention will be excluded.
研究组 & 干预措施
intervention group
Will receive one session of up to one-hour per week over a six-week period in self-management in addition to their usual rehabilitation and workbook.
干预措施: self-management (Other)
control group
Will receive booklet consist of home exercises and education besides the usual care
干预措施: Control (Other)
结局指标
主要结局
Stroke Self-Efficacy Questionnaire(SSEQ):
时间窗: baseline to the 6 months after intervention
The SSEQ is a 13 point questionnaire developed by Jones et al (2008) and is aimed to determine the individuals perceived level of self-efficacy in completing a range of relevant functional tasks, such as walking, getting comfortable in bed, as well as several self-management tasks
次要结局
- The Mini-BESTest:(baseline to the 6 months after intervention)
- The Subjective Index of Physical and Social Outcome scale(baseline to the 6 months after intervention)
- National Institute for Health Stroke Scale(baseline to the 6 months after intervention)
- The Rivermead Mobility Index:(baseline to the 6 months after intervention)
- 6-minute walk test(baseline to the 6 months after intervention)
- Rivermead Activities of Daily Living Scale:(baseline to the 6 months after intervention)
- Action Research Arm Test(baseline to the 6 months after intervention)
研究者
Reham Nasir
Principal investigator
University of the Western Cape