一项针对1型糖尿病青少年和年轻成年人的临床医疗转型准备计划:SHIFT随机临床试验的研究协议
Laura J Caccavale1, Randi Streisand2,3, Jessica Gokee LaRose4
1Children's Hospital of Richmond at Virginia Commonwealth University, Department of Pediatrics, Richmond, VA, 23298, United States of America.
Contemporary clinical trials communications
|June 18, 2025
概括
这项研究测试了T1D (SHIFT) 转型支持健康改善计划,以帮助1型糖尿病 (T1D) 的青少年和年轻人在过渡到成人护理期间管理他们的健康.
科学领域:
- 儿科内分泌学 儿科内分泌学
- 临床试验 临床试验
- 医疗保健的转型 医疗保健的转型
背景情况:
- 83%患有1型糖尿病 (T1D) 的青少年和年轻人 (AYA) 的血糖控制不理想,增加并发症风险.
- 需要有效的策略来改善AYA在过渡到成人医疗之前改善T1D管理.
- 在T1D (SHIFT) 转型支持健康改善试验中,通过基于临床的干预来解决这一差距.
研究的目的:
- 评估SHIFT过渡准备干预对T1D的AYA的初步疗效.
- 评估干预对血糖结果,过渡准备和自我管理行为的影响.
- 为了为这个人群提供未来更大规模的医疗保健转型试验信息.
主要方法:
- 一项随机临床试验,涉及50名AYA (16-22岁) 与T1D及其护理人员.
- 参与者随机分配到6个月的SHIFT计划或通常的增强治疗 (TAU+).
- 干预包括精神教育,技能培养,行为自我管理支持和加强从业者沟通;在基线,6个月,9个月和12个月进行评估.
主要成果:
- 在研究完成后,将报告初步的疗效发现.
- 血红蛋白A1c,过渡准备和糖尿病自我管理行为是主要的结果指标.
- 这项研究被注册为NCT05639088.8.
结论:
- SHIFT试验的结果将指导未来的研究,以优化T1D的AYA的医疗保健过渡.
- 成功的过渡准备对于改善这一人口群的长期健康结果至关重要.
- 这项研究设计为开发基于证据的过渡干预提供了基础.
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