统计分析计划,以重复为重点的社区支持,以避免再接收和改善中风后的参与随机对照临床试验
Monique F Kilkenny1,2, Muideen T Olaiya1, Janette Cameron1
1Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia.
Trials
|January 23, 2024
概括
针对康复的社区支持,以避免再入院和改善中风后的参与 (ReCAPS) 试验测试了一种数字健康干预措施,以减少中风后的非计划性医院访问. 本统计分析计划概述了评估其有效性的方法.
科学领域:
- 神经学 神经学
- 数字健康数字健康
- 医疗保健服务研究 医疗服务研究
背景情况:
- 脑卒中后不规划的医院呈现往往源于医院到家的过渡支持不足.
- 针对康复的社区支持以避免再接收和改善中风后参与 (ReCAPS) 试验解决了这一差距.
- 开发了一项为期12周的自我管理干预,包括个性化的目标设定和数字消息传递.
研究的目的:
- 提交ReCAPS试验的统计分析计划.
- 概述评估数字健康支持套餐在减少中风后计划外送医院治疗有效性的方法.
主要方法:
- 1:1随机化,按年龄和基线残疾分层.
- 890名参与者的样本大小计算为10%的绝对减少计划外医院呈现.
- 对分层变量调整后的逻辑回归将分析主要结果 (90天内计划外出医院).
- 治疗意向分析将用于主要结果.
主要成果:
- 主要结局:在随机化后90天内自我报告的计划外医院呈现 (急诊室/入院).
- 二次结果将使用适当的回归模型进行评估.
- 统计学意义将通过p值≤0.05来确定.
结论:
- 统计分析计划确保对ReCAPS试验结果的透明报告.
- 预计ReCAPS试验将提供关于数字健康干预措施对中风后护理有效性的新证据.
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