STRIVE试验:在手术前进行虚拟环境中改善健身的结构化训练 (STRIVE) 的多中心实用性内部试验随机对照试验的协议
Daniel I McIsaac1, Puneeta Tandon2, Gurlavine Kidd3
1Anaesthesiology and Pain Medicine, Ottawa Hospital Research Institute Clinical Epidemiology Programme, Ottawa, Ontario, Canada dmcisaac@toh.ca.
BMJ open
|November 7, 2024
概括
这项研究试点为手术患者提供虚拟预康复计划,旨在提供高效,可扩展和可访问的护理. 该试验将评估可行性,包括招募和坚持,以告知未来的大规模研究.
科学领域:
- 在外科手术期间的医学.
- 数字健康干预措施 数字健康干预措施
- 手术结果研究研究.
背景情况:
- 基于家庭,虚拟支持的预康复模式为患者护理提供可扩展的解决方案.
- 虚拟预康复方法仍未得到充分研究,需要进一步研究.
- 本稿概述了一项内部试点随机对照试验 (RCT) 的协议,该试验是虚拟交付的多模式预康复干预.
研究的目的:
- 评估基于家庭的可行性,虚拟支持的多模式预康复计划.
- 评估虚拟预康复干预的招聘,坚持和保留率.
- 确定实施虚拟预康复实用试验的障碍和促进者的障碍.
主要方法:
- 一个务实的,内部的试点RCT,将家庭虚拟预康复与标准护理进行比较.
- 接受选择性胸部,腹部,骨盆和血管手术的参与者将从加拿大五家医院招募.
- 该干预涉及3-12周的运动,营养和通过在线平台提供的心理社会支持.
主要成果:
- 主要可行性结局包括每月招募 (> 6 /中心),干预坚持 (> 75%) 和手术后30天保留 (> 90%).
- 计划采用144名参与者的样本规模,以确保精确估计可行性指标.
- 该研究将跟踪参与者长达1年,数据可能会迁移到全面试验中.
结论:
- 该试验RCT协议旨在严格评估一种新的虚拟预康复交付模型.
- 这种虚拟模型的成功实施可以提高预康复的可访问性和可扩展性.
- 结果将为未来的大规模试验的设计和执行提供信息,调查虚拟预康复对手术结果的影响.
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