远程进行临床试验:从一个分散的多中心随机对照试验中吸取的经验教训,评估慢性病的数字健康干预
Gurneet Kaur Sohansoha1,2,3, Noemi Vadaszy3, Ella C Ford1,2,4
1Leicester Kidney Lifestyle Team, Department of Population Health Sciences, University of Leicester, Leicester, United Kingdom.
PLOS digital health
|February 20, 2026
概括
分散临床试验 (DCT) 可以有效地招募许多参与者. 然而,研究人员报告了意想不到的挑战,强调了未来DCT设计需要仔细规划的必要性.
科学领域:
- 临床试验 临床试验
- 数字健康数字健康
- 慢性病研究 慢性病研究
背景情况:
- 分散临床试验 (DCT) 在研究交付方面提供了潜在的效率和成本效益.
- 针对慢性病的My Kidneys & Me数字健康干预使用多中心随机DCT (SMILE-K) 进行了评估.
研究的目的:
- 评估SMILE-K DCT的招聘结果和研究人员的经验.
- 为未来分散的临床试验的设计和实施提供信息.
主要方法:
- 在SMILE-K试验中,完全采用了远程处理,包括在线结果测量.
- 对招聘和保留的定量数据进行了描述性分析.
- 与研究人员进行的半结构面试探索了远程试验过程的经验,并以主题分析.
主要成果:
- 招募了420名参与者;远程预约后通过邮件发送的邀请传单取得了最大的成功.
- 研究人员认为DCT对环境友好,并允许多样化的参与.
- 预期和实际的招聘率之间存在差异,员工面临着不可预期的挑战.
结论:
- DCT可以实现较高的参与者招聘数量.
- 邮寄邀请传单后远程预约是一个有效的招聘策略.
- 未来的DCT设计需要仔细考虑招聘和参与因素,解决员工发现的挑战.
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