A Post-market Cluster Randomized Controlled Trial of the Effect of the TENA SmartCare Change Indicator on Continence Care Efficiency and Skin Health in Long Term Care Facilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Care Efficiency score
研究概览
简要总结
The purpose of this post market clinical investigation is to demonstrate the performance and safety of the TENA SmartCare Change Indicator when used in a nursing home setting.
详细描述
The TENA SmartCare Change Indicator is intended for use on individuals suffering from Urinary Incontinence who are cared for in a nursing home environment, by one or more professional caregivers. The TENA SmartCare Change Indicator is an accessory to TENA absorbing incontinence products. This clinical investigation is intended to demonstrate that use of TENA SmartCare Change Indicator has the ability to increase continence care efficiency at the nursing home by reducing the time needed in daily handling of absorbing incontinence products. Furthermore, this reduction in needed care does not have a detrimental effect on skin health. Secondarily, the investigation have multiple outcomes regarding number of checks, changes and leaks and also quality of life for subjects and qualitative measures for caregivers. Furthermore, the safety will continuously be monitored through analyzing device-related adverse events reported during the investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has urinary incontinence managed with incontinence products with tapes, belted or pull up incontinence product type (products for moderate to heavy incontinence).
- •Subject is a permanent (intended length of stay four months or longer) resident of the nursing home.
- •Subject is unable to consistently communicate toileting needs.
- •Subject is unable to successfully toilet and change the pad without assistance.
- •Subject is using or is willing to use TENA Slip (Stretch) TENA Flex (Belted) and TENA Pants (Underwear) absorbing products for the study.
- •Subject has a waist size appropriate to the available sizes of incontinence products.
- •Subject is willing and able to provide informed consent to participate or if unable to provide consent have a legal representative who is willing and able to provide informed consent on behalf of the subject.
- •Subject is part of a continence care regimen, defined as "check and change", using any method.
- •If applicable, subject is to be on a stable regimen of medications for urinary incontinence
- •Subject is over 18 years of age.
排除标准
- •Subject has frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.
- •Subject has severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss & infection).
- •Subject has any type of indwelling or external urinary catheter(s).
- •Subject is anuric.
- •Subject is managed using another automated or digital health technology incontinence management device.
- •Subject has responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical.
- •Subject has any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
- •Subject has a life expectancy of fewer than 3 months or be receiving palliative or terminal care.
- •Subject has participated in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the clinical investigation.
- •Subject is dependent on either alcohol or recreational drugs.
研究组 & 干预措施
Device
Clusters in this arm will start using the device and use it for 6 weeks.
干预措施: TENA SmartCare Change Indicator (Device)
Control
Clusters in this arm will not receive the device it will continue with usual care with no changes.
结局指标
主要结局
Care Efficiency score
时间窗: 10 weeks.
Care efficiency is the weighted sum of the pre-defined care events divided by the number of recorded diary days of the subject in question. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily care efficiency score (min/day). Data is collected daily via the study diary.
Daily Skin Health score
时间窗: 10 weeks.
Skin health score is based on skin health grades (from 0, no skin problems to 4, very seveer skin problems) that have been reported by the caregiver in the study diary. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily skin health score.
Care Efficiency score
时间窗: 10 weeks.
Care efficiency is the weighted sum of the pre-defined care events divided by the number of recorded diary days of the subject in question. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily care efficiency score (min/day). Data is collected daily via the study diary.
Daily Skin Health score
时间窗: 10 weeks.
Skin health score is based on skin health grades (from 0, no skin problems to 4, very seveer skin problems) that have been reported by the caregiver in the study diary. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared. Data is presented as average daily skin health score.
次要结局
- Level of agitation and responsive behavior.(10 weeks.)
- Number of continence care product checks(10 weeks.)
- Number of continence care product changes(10 weeks.)
- Number of continence care toilet visits(10 weeks.)
- Number of continence care clothing changes(10 weeks.)
- Number of continence care bed linen changes(10 weeks.)
- The time spent on continence care episodes(10 weeks.)
- Skin health score(10 weeks.)
- Quality of life and level of utility(10 weeks.)
- Quality of life according to the QoL-AD(10 weeks.)
- Number of sleep interruptions due to continence care(10 weeks.)
- Total absorption value(10 weeks.)
- Caregiver work engagement(10 weeks.)
- Caregiver work conditions(10 weeks.)
- Time spent in a saturated continence care product(10 weeks)
- Number of unnecessary checks.(10 weeks)
- Qualitative data on implementation, uptake, opportunities and barriers to use.(10 weeks.)
- Safety data for the device.(10 weeks.)