针对患有复杂先天性心脏病的学龄儿童的多模式个性化执行功能干预 (E-Fit):随机对照可行性研究的方案
Alenka Sarah Schmid1, Melanie Ehrler1,2,3, Flavia Wehrle1,2,4
1Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland.
BMJ open
|November 9, 2023
概括
这项研究测试了E-Fit的可行性,这是一种针对患有复杂先天性心脏病 (CHD) 和执行功能 (EF) 挑战的儿童的新型个性化干预. 结果将指导未来的试验,改善EF在这个脆弱的人群.
科学领域:
- 儿童心脏病学 儿童心脏病学
- 神经发育障碍 神经发育障碍
- 康复医学 康复医学 康复医学
背景情况:
- 患有先天性心脏病 (CHD) 的儿童经常经历执行功能 (EF) 障碍.
- 目前针对复杂心血管疾病EF缺陷的干预措施的有效性有限.
- 为了应对这些挑战,开发了一种新的,个性化的多式联通干预 (E-Fit).
研究的目的:
- 评估E-Fit干预对患有复杂心脏病和EF损伤的儿童的可行性.
- 收集关于招聘,坚持和参与者/提供者经验的数据.
- 为未来随机对照试验 (RCT) 的设计提供信息,调查E-Fit的有效性.
主要方法:
- 一个单中心,单盲,随机控制的可行性研究.
- 招收了40名患有心脏病和显著EF损伤的儿童 (10-12岁).
- 干预组接受了基于计算机的个性化培训,远程指导和游戏;对照组遵循通常的例行程序.
主要成果:
- 可行性将通过坚持,招聘率和参与者/提供者的反来衡量.
- 该研究旨在评估E-Fit在患有心脏病的儿童中改善EF的潜力.
- 收集的数据将决定一个更大的RCT的可行性.
结论:
- E-Fit干预表明,作为改善复杂心血管疾病儿童执行功能的可行方法,它是有前途的.
- 可行性调查结果将指导开发一个全面的RCT.
- 这项研究解决了儿童慢性心脏病中有效的EF干预措施的关键需求.
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