一种多组件复杂干预,用于慢性心力衰竭患者的支持性随访:一项随机对照试点研究 (UTILE项目)
Petra Schäfer-Keller1,2, Denis Graf3, Kris Denhaerynck4
1Institute of Applied Research in Health, School of Health Sciences Fribourg, HES-SO University of Applied Sciences and Arts Western Switzerland, Fribourg, Switzerland. petra.schaefer-keller@hefr.ch.
Pilot and feasibility studies
|June 27, 2023
概括
这项试点研究表明,对于心力衰竭患者来说,一种新的干预措施是可行的和可以接受的. 需要进一步的研究,以提高全面试验的干预忠实度.
科学领域:
- 心脏病学 心脏病学
- 临床试验 临床试验
- 医疗保健服务研究 医疗服务研究
背景情况:
- 心力衰竭 (HF) 带来了显著的症状负担,发病率,死亡率和生活质量 (QoL) 的降低.
- 为了应对高频管理中的这些挑战,开发了一种新的多元组件复杂干预措施.
- 这项研究旨在评估这种干预措施的可行性和潜在结果,以指导未来的研究.
研究的目的:
- 评估针对心力衰竭 (HF) 患者的新型多组件复杂干预的可行性.
- 评估潜在的患者报告和干预的临床结果.
- 为未来在瑞士进行全规模随机对照试验 (RCT) 的设计提供信息.
主要方法:
- 一项试点随机对照试验 (RCT) 在二级护理医院环境中进行.
- 患有HF的参与者被随机分配到通常的护理 (对照组,CG) 或接受通常护理加上新干预的干预组 (IG).
- 可行性通过招聘率,学习护士时间,消耗,咨询细节,可接受性和忠诚度来评估. 患者报告的结局 (自我护理,KCCQ-12) 和临床结局 (死亡率,住院) 在3个月的随访期被测量.
主要成果:
- 在62周内,招募了60名患有HF的参与者,招募率为46.15%,退出率为31.7%.
- 该干预表明了高可接受性和0.71.7的平均忠实度. 与CG相比,IG观察到自我护理管理的显著改善 (科恩d = 0.59).
- 虽然KCCQ-12效应大小小小,但更少的IG参与者经历了健康状况恶化. 在IG中,住院病例和住院日数较低.
结论:
- 新的多组分干预,研究方法和结果测量被发现是可行的,并且可以接受心力衰竭患者.
- 应为未来的全面试验实施增强干预忠实性的策略.
- 这些发现支持向更大,多中心的RCT进行进展,以确认干预的有效性.
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