在多发性硬化症中增加身体活动的行为干预的随机对照试验项目:忠诚度监测和结果
Stephanie L Silveira1, Ariel Kidwell-Chandler2, Trinh L T Huynh2
1Department of Management, Policy, and Community Health, University of Texas Health Science Center at Houston, Houston, TX, USA.
Behavioral medicine (Washington, D.C.)
|September 17, 2024
概括
这项研究评估了在多发性硬化症 (MS) 患者体力活动临床试验中的治疗忠实性. 通过全面监测实现了高准确度,确保了MS患者可靠的干预交付.
科学领域:
- 行为医学是一种行为医学.
- 临床试验 临床试验
- 多发性硬化症研究研究
背景情况:
- 治疗忠实性对于行为医学临床试验的可靠性和有效性至关重要.
- 评估和确保真实性对于准确解释试验结果至关重要.
研究的目的:
- 报告预先计划的忠实性监测协议的结果,用于多发性硬化症 (BIPAMS) 身体活动行为干预的第三阶段临床试验.
- 为更广泛地采用标准协议提供了解解密治疗忠实性监测的见解.
主要方法:
- 实施了一项全面的忠诚度监测协议,纳入了NIH行为变化联盟的五个领域.
- 数据来源包括教练呼叫检查清单,日志,专家审计,参与者参与度量和团队会议.
- 培训了10名教练来提供研究协议,包括定向和行为辅导电话.
主要成果:
- 这项研究涉及269名参与者 (135名在BIPAMS中,134名在WellMS控制中) 在24周内.
- 观察到辅导电话的完成率很高 (11.81/13对于BIPAMS,8.19/9对于WellMS).
- 计划审计的很大一部分完成了 (62%为BIPAMS,55%为WellMS),由于COVID-19大流行病而出现了偏差.
结论:
- BIPAMS忠实性监测协议的有效实施和遵守得到了证明.
- 获得的见解可以促进在行为医学试验中广泛使用标准化治疗忠实性监测.
- 确保高治疗准确性对于多发性硬化症等疾病中临床研究的完整性至关重要.
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