Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users: a Randomized Waitlist-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change from baseline in Wheelchair Skills Test Questionnaire at 18 weeks
研究概览
简要总结
Although there have been a small number of studies suggesting the important role that caregivers play in assisting wheelchair users with mobility, there has never been a randomized controlled trial (RCT) looking at the effectiveness or cost-utility of wheelchair skills training for caregivers. The overall goal of this study is to correct this knowledge gap and, triggered by the COVID-19 pandemic of 2020, to conduct the training remotely. The main purpose of this study is to test if providing wheelchair skills training remotely to caregivers of manual wheelchair users enhances caregiver-assisted wheelchair skills ability and confidence in comparison to a control group of participants who are receiving usual care and self-study material on wheelchair skills. The investigators will also study whether the benefits of training are still seen at a 6-week follow-up and assess the health-economic impact of caregiver training.
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
- Single (Outcomes Assessor)
盲法说明
This is a single-blind study. The outcomes assessor will be blind to group allocation. Because of the nature of the study, it will not be possible to blind participants or trainer.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for caregiver and wheelchair user dyad
- •be ≥ 18 years of age
- •able to communicate in English
- •be willing to participate and be committed to setting regularly scheduled times for the study activities
- •will need to have the appropriate connectivity for the remote training and testing (i.e. telephone, limited-access e-mail and internet).
排除标准
- •for caregiver and wheelchair user dyad :
- •fail to complete the baseline (T1) assessment
- •have unstable medical conditions (e.g. angina, seizures) that might make the use of a manual wheelchair dangerous
- •emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant
- •have a medical condition that is likely to deteriorate in the three months following enrollment.
- •Inclusion Criteria for wheelchair user
- •a person who uses a manual wheelchair
- •be expected to continue to use a manual wheelchair at least part-time in the coming months
- •requires no more than minimal assistance for communication and auditory comprehension
- •Inclusion Criteria for caregiver of wheelchair user
- •must be a caregiver (e.g. a family member, friend, volunteer or regular homecare worker) who spends an average total of at least 2 hours per week with the manual wheelchair user that includes manual wheelchair mobility.
研究组 & 干预措施
Treatment
The wheelchair user and caregiver will be trained together on wheelchair skills using remote technology (Zoom for healthcare and/or Facetime).
干预措施: Remote wheelchair skills training (Other)
Control
The wheelchair user and caregiver will receive the same self-study materials provided to the Treatment arm. Usual care, which may include wheelchair skills training for both wheelchair users and caregivers( but which often does not do so to an adequate extent) by wheelchair user's clinical therapist.
结局指标
主要结局
Change from baseline in Wheelchair Skills Test Questionnaire at 18 weeks
时间窗: 18 weeks
Change from baseline in self-reported ability and confidence to perform 33 wheelchair skills. Score ranges from 0-100%, with 0 indicating a poor outcome (not able to do any wheelchair skills and 100% indicating being able to do all the skills).
Change from baseline in Wheelchair Skills Test Questionnaire at 5 weeks
时间窗: 5 weeks
Change from baseline in self-reported ability and confidence to perform 33 wheelchair skills. Score ranges from 0-100%, with 0 indicating a poor outcome (not able to do any wheelchair skills and 100% indicating being able to do all the skills).
次要结局
- Satisfaction with wheelchair skills training over course of study(5 weeks, 18 weeks)
- Change from baseline in quality of life at 18 weeks(18 weeks)
- Cost-effectiveness of training(5 weeks)
- Change from baseline in quality of life at 5 weeks(5 weeks)
研究者
Lee Kirby
Principal Investigator
Nova Scotia Health Authority