评估脏的安全性和性能You App 慢性脏病:意大利多中心,随机,开放标签,市场前研究的协议
Cesira Cafiero1, Marco Gnesi2, Anna Rita Maurizi3
1Nephrology, Dialysis and Transplantation Unit of the University Hospital Consortium, Bari, Italy.
JMIR research protocols
|February 25, 2026
概括
这项研究评估了 KidneYou,这是一款为慢性病 (CKD) 患者提供营养,体力活动和正念计划的数字工具. 结果将显示,与标准护理相比,这种非药理学方法是否能改善健康结果.
科学领域:
- 科和数字健康
- 综合医学治疗慢性疾病
背景情况:
- 慢性病 (CKD) 涉及长期损伤,可能导致衰竭.
- 保守管理包括营养计划 (NP),体育活动 (PA) 和正念计划 (MP) 来减缓进展.
- KidneYou是一个集成NP,PA和MP的数字医疗设备,用于非药物治疗的CKD管理.
研究的目的:
- 评估数字医疗设备KidneYou的疗效和安全性.
- 为了比较KidneYou的个性化NP,PA计划和MP与慢性病患者的标准护理.
主要方法:
- 一个多中心的,开放的,随机的试验,将KidneYou (数字NP,PA,MP) 与标准方法 (纸质日记) 进行比较.
- 该研究的持续时间为3个月.
- 主要终点:实现至少三个条件中的一个 (10%的阿佐图里亚减少,15%的6分钟步行测试改善,或10%的感知压力减少).
主要成果:
- 数据分析正在进行中.
- 招聘发生在2022年7月至2024年4月.
- 预计结果将在2026年初公布.
结论:
- 这项试验将为未来关于用于CKD管理的数字设备的研究提供信息.
- 这些发现可能表明KidneYou有潜力改善患者的治疗结果,并促进更健康的生活方式.
- 这项研究旨在建立一种非药理学方法,以实现更有效的CKD自我管理.
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