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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
108
The intervention is a medical device system that consists of a reusable electronic sensor and an application installed on one or more smart phones. The device estimates the saturation level of an absorbing incontinence product used by a study subject. The device is non-invasive and does not have any effect on the function of the absorbing incontinence product.
University of Alberta
Edmonton, Alberta, Canada
Hochschule Niederrhein University of Applied Sciences
Krefeld, Germany
Care Efficiency score
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.
Time frame: 10 weeks.
Daily Skin Health score
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.
Time frame: 10 weeks.
Number of continence care product checks
From the study diary the number of checks of absorbing incontinence products is retrieved. 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 number of checks.
Time frame: 10 weeks.
Number of continence care product changes
From the study diary the number of changes of absorbing incontinence products is retrieved. 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 number of changes.
Time frame: 10 weeks.
Number of continence care toilet visits
From the study diary the number of toilet visits is retrieved. 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 number of toilet visits.
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Time frame: 10 weeks.
Number of continence care clothing changes
From the study diary the number of clothing changes due to leakages is retrieved. 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 number of clothing changes.
Time frame: 10 weeks.
Number of continence care bed linen changes
From the study diary the number of bed linen changes due to leakages is retrieved. 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 number of linen changes.
Time frame: 10 weeks.
The time spent on continence care episodes
From the study diary the total time spent on continence care is retrieved. 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 time spent on continence care.
Time frame: 10 weeks.
Skin health score
Measured by the skin health assessment tool at study completion visit and compared to the end of baseline visit.
Time frame: 10 weeks.
Quality of life and level of utility
Measured using the EQ-5D-5L questionnaire at study completion visit and compared to the end of baseline visit.
Time frame: 10 weeks.
Quality of life according to the QoL-AD
Measured and scored at completion visit and compared to the end of baseline visit.
Time frame: 10 weeks.
Level of agitation and responsive behavior.
Measured via interRAI Aggressive Behavior Scale at study completion visit and compared to the end of baseline visit.
Time frame: 10 weeks.
Number of sleep interruptions due to continence care
From the study diary the number of sleep interruptions are retrieved. 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 number of interruptions.
Time frame: 10 weeks.
Total absorption value
From the study diary the type, number and absorption value of the incontinence care product is retrieved. This data is used to create a total absorption measure. The last week of the 4 week baseline and last week of the 6 week intervention/control time period is to be compared.
Time frame: 10 weeks.
Caregiver work engagement
Using the UWES questionnaire the work engagement of caregivers are measured at a cluster's end-of-trial visit and compared to the end of baseline visit.
Time frame: 10 weeks.
Caregiver work conditions
Measured using the organizational headroom questionnaire at a cluster's end-of-trial visit and compared to the end of baseline visit.
Time frame: 10 weeks.
Time spent in a saturated continence care product
Data from study diary used to retrieve the total hours that occur between an observed fully saturated product and the change of the saturated product. 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 time spent in the saturated product.
Time frame: 10 weeks
Number of unnecessary checks.
Data from study diary used to retrieve the number of unnecessary checks/changes. An unnecessary check/change is defined as, an activity line where a product check was performed but no product change occurred or an activity line where a product change occurred but neither a fully nor partially saturated product was indicated. 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 number of checks/changes.
Time frame: 10 weeks
Qualitative data on implementation, uptake, opportunities and barriers to use.
Response to interviews with caregivers, coded by the investigator and collated into trends and themes. Conducted after completion of study for subjects.
Time frame: 10 weeks.
Safety data for the device.
Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD).
Time frame: 10 weeks.