TENA SmartCare 变更指示器对老年养老院居民尿失禁护理效率和皮肤健康影响的上市后群组随机对照试验
A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents.
机构信息
Division of Geriatric Medicine, Department of Medicine, University of Alberta, Edmonton, AB, Canada.
Essity Hygiene & Health AB, 405 03, Gothenburg, Sweden.
出版信息
Trials. 2023 Feb 3;24(1):80. doi: 10.1186/s13063-022-07031-z.
BACKGROUND
Urinary continence care for residents of nursing homes who are unable to communicate their toileting needs usually involves care aides manually checking continence products (pads) to determine the level of urine saturation prior to changing. The TENA SmartCare Change Indicator is a medical device which estimates urine saturation and notifies caregivers of the optimal time for pad changes. This study will seek to examine the effect of the TENA SmartCare Change Indicator on urinary continence care efficiency and skin health, in comparison to usual care.
METHODS
This cluster randomized controlled trial (NCT05247047) involving older nursing home residents with urinary incontinence unable to consistently indicate their toileting needs, and their care aides, will compare technology-based and usual continence care over a period of 8 weeks. Co-primary endpoints of superiority in continence care efficiency and non-inferiority in the maintenance of skin health will be assessed. Secondary outcomes will examine the resident quality of life, sleep quality, responsive behaviours, changes in pad use and leakage episodes outside the pad. Change in care aide work engagement, job satisfaction and rushed tasks will be assessed. Benefits and challenges with the use of the device for continence care will be identified from the perspectives of the care staff.
DISCUSSION
Urinary continence assessment and care in nursing homes is reported as suboptimal and threatening to dignity. Data on the utility and effect of technological solutions for improving urinary continence care are few and conflicting. If shown effective, this technological solution has the potential to improve the care for older residents and improve the working lives of caregiving staff who look after this most vulnerable section of the population.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05247047. Registration date is Feb 18, 2022.
背景
对于无法表达如厕需求的养老院居民，其尿失禁护理通常涉及护理人员手动检查失禁产品（垫），以确定更换前的尿液饱和程度。TENA SmartCare 变更指示器是一种医疗器械，可估计尿液饱和程度，并在更换垫子的最佳时间通知护理人员。本研究旨在比较 TENA SmartCare 变更指示器与常规护理对尿失禁护理效率和皮肤健康的影响。
方法
这项涉及有尿失禁且无法始终如一地表示如厕需求的老年养老院居民及其护理人员的聚类随机对照试验（NCT05247047），将在 8 周的时间内比较基于技术和常规的失禁护理。主要优势终点是评估护理效率，次要终点是评估皮肤健康的非劣效性。次要结果将评估居民的生活质量、睡眠质量、反应行为、垫使用变化和垫外漏尿事件。还将评估护理人员工作投入、工作满意度和匆忙任务的变化。将从护理人员的角度评估该设备在失禁护理中的使用的益处和挑战。
讨论
养老院的尿失禁评估和护理被报道为不尽如人意，并威胁到尊严。关于改善尿失禁护理的技术解决方案的实用性和效果的数据很少且存在冲突。如果被证明有效，这种技术解决方案有可能改善对老年居民的护理，并改善照顾这一最脆弱人群的护理人员的工作生活。
试验注册
ClinicalTrials.gov NCT05247047。注册日期为 2022 年 2 月 18 日。
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