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临床试验/NCT03856749
NCT03856749已完成不适用

Effectiveness of Wheelchair Skills Training for Caregivers of Manual Wheelchair Users: a Randomized Waitlist-controlled Trial

Lee Kirby2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年12月4日最近更新:
适应症

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
2
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

入选标准

  • 未提供

排除标准

  • 未提供

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

发起方
Lee Kirby
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lee Kirby

Principal Investigator

Nova Scotia Health Authority

研究点 (2)

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