The Integration of Sensor Technology Into Incontinence Materials: a Single-group Pretest-posttest Study in a Nursing Home Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Frequency of skin irritations
研究概览
简要总结
The smart diaper aims to (1) detect humidity, (2) be capable of sending real-time indication of the saturation to the healthcare workers when urine loss occurs and (3) generate alerts when the diaper requires changing. Potential benefits of the smart diaper compared to incontinence management products without sensor technology include: workload reduction, increased comfort for residents and staff, more person-centred care, increased quality of care, less skin damage and economic (e.g. less costs due to less excessive diaper changes), and/or environmental (e.g. less waste) gains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident of nursing home
- •Urinary incontinence or double incontinence (Katz score incontinence ≥ 3) by day and night. (Score assessed in one week interval before start study period 1 and 2 "D1")
- •Wearing adult diapers as incontinence material, size M.
- •Unable to change diaper independently when saturated or leaking (Katz score toileting ≥ 3). (Score assessed in one week interval before start study period 1 and 2 "D1")
- •Written informed consent from resident or resident's legal representative.
- •Dutch speaking
排除标准
- •Residents who are receiving end-of-life care
- •Residents with a Mini-Mental State Examination (MMSE)-score of < 24
- •Residents with a dominant belly sleeping position
研究组 & 干预措施
Residents
5 residents - fase 1 Intervention device: smart diaper (diaper, sensor and strips, without alerting system).
15 residents -fase 2, of which 5 residents of study phase 1 Intervention device: smart diaper (diaper, sensor and strips, with alerting system)
干预措施: Smart diapers (Device)
结局指标
主要结局
Frequency of skin irritations
时间窗: 10 days
3\. The frequency of skin irritations related to incontinence (Incontinence-Associated Dermatitis or IAD) in the gluteal/sacral area (assessed daily during each study period\*).
Mean percentage saturation
时间窗: 10 days
The difference between the percentage saturation determined by the smart diaper and the percentage saturation based on the data registered in the frequency volume urine charts (FVUCs) (during each study period\* for each diaper change)
The % of correct warnings
时间窗: 10 days
= warning on saturation of the incontinence material) generated by the sensor. a. Each warning generated by the sensor will be assessed by the nurse (correct/incorrect warning)
次要结局
未报告次要终点