跳至主要内容
临床试验/NCT06613503
NCT06613503招募中不适用

Testing the Effectiveness of the AI-Supporter in Reducing Urinary Tract Infections, Incontinence-associated Dermatitis and Caregiving Costs for Incontinence Patients

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
white blood cells

研究概览

简要总结

The "AI Supporter," an intelligent excretion management robot, leverages artificial intelligence-based vision recognition to autonomously detect and cleanse affected areas, followed by drying and changing the diaper, thereby reducing caregiver strain and enhancing care quality. This study aims to assess the efficacy of the "AI Supporter" in decreasing the incidence of urinary tract infections and incontinence-associated dermatitis among incontinent patients, in addition to exploring its cost-effectiveness.

Adopting an experimental (two groups) and longitudinal design, this research utilizes both convenience and random sampling strategies. The study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary and/or fecal incontinence. Participants will intermittently use the AI Supporter over a 14-day period. Measurement tools include routine urine analysis.

详细描述

Background: As Taiwan progresses medically, the aging demographic has become a significant challenge, leading to an escalation in the disabled population. The lack of caregiving manpower represents a critical bottleneck in the provision of long-term care. Diaper changing, a daily and labor-intensive task for caregivers, involves bending motions that pose a risk of musculoskeletal injuries. Consequently, the imperative development of automated caregiving technologies has emerged. The "AI Supporter," an intelligent excretion management robot, leverages artificial intelligence-based vision recognition to autonomously detect and cleanse affected areas, followed by drying and changing the diaper, thereby reducing caregiver strain and enhancing care quality.

Objective

This study aims to assess the efficacy of the "AI Supporter" in decreasing the incidence of urinary tract infections and incontinence-associated dermatitis among incontinent patients, in addition to exploring its cost-effectiveness.

Methods: Adopting an experimental (two groups) and longitudinal design, this research utilizes both convenience and random sampling strategies. Scheduled from November 2024 to October 2025 at a residential long-term care facility in Central Taiwan, the study anticipates recruiting 60 female subjects who have been confined to bed for more than three months with urinary and/or fecal incontinence. Participants will intermittently use the AI Supporter over a 14-day period. Measurement tools include routine urine analysis, incontinence-associated dermatitis rating scales, pressure sore assessments, skin pH measurements, caregiver hours, and cost analyses pertaining to diapers and the AI Supporter. The principal analytical method employed will be Generalized Estimating Equations (GEE), with statistical significance defined at p < 0.05.

Expected Outcomes: The AI Supporter is expected to significantly reduce the occurrence of urinary tract infections and incontinance-associated dermatitis in patients, concurrently alleviating caregiver workload and diminishing associated costs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants must have been bedridden for at least 3 months and have urinary and/or fecal incontinence.
  • Female participants aged over 20 years old.
  • Participants must be capable of wearing the AI-supporter device during the study period.

排除标准

  • Participants with severe skin conditions unrelated to incontinence.
  • Participants with current urinary tract infections or incontinence-associated dermatitis at the time of enrollment.
  • Participants who are unable to provide informed consent or have a legal representative to do so.

结局指标

主要结局

white blood cells

时间窗: 14 days after intervention

urine analysis

Bacterial count

时间窗: 14 days after intervention

urine analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effectiveness of the AI-Supporter in Reducing... | 临床试验