The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247047
• Other study ID #: WHEELS-ONE
• Status: Completed
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2024
• Source: Essity Hygiene and Health AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 30, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject has urinary incontinence managed with incontinence products with tapes, belted or pull up incontinence product type (products for moderate to heavy incontinence).

2. Subject is a permanent (intended length of stay four months or longer) resident of the nursing home.

3. Subject is unable to consistently communicate toileting needs.

4. Subject is unable to successfully toilet and change the pad without assistance.

5. Subject is using or is willing to use TENA Slip (Stretch) TENA Flex (Belted) and TENA Pants (Underwear) absorbing products for the study.

6. Subject has a waist size appropriate to the available sizes of incontinence products.

7. 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.

8. Subject is part of a continence care regimen, defined as "check and change", using any method.

9. If applicable, subject is to be on a stable regimen of medications for urinary incontinence

10. Subject is over 18 years of age.

Exclusion Criteria:

1. Subject has frequent (daily) faecal incontinence in the pad or having severe problems with faecal incontinence as determined by the investigator.

2. Subject has severe incontinence product related skin problems, as defined by the GLOBIAD categorization 2B (skin loss & infection).

3. Subject has any type of indwelling or external urinary catheter(s).

4. Subject is anuric.

5. Subject is managed using another automated or digital health technology incontinence management device.

6. Subject has responsive behaviors of sufficient severity, in the opinion of the care staff, to make participation impractical.

7. Subject has any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.

8. Subject has a life expectancy of fewer than 3 months or be receiving palliative or terminal care.

9. 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.

10. Subject is dependent on either alcohol or recreational drugs.

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• TENA SmartCare Change Indicator
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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Germany	Hochschule Niederrhein University of Applied Sciences	Krefeld

Sponsors (1)

Lead Sponsor	Collaborator
Essity Hygiene and Health AB

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 collected daily via the study diary.	10 weeks.
Primary	Daily Skin Health score	Skin health score is based on skin health grades 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.	10 weeks.
Secondary	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.	10 weeks.
Secondary	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.	10 weeks.
Secondary	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.	10 weeks.
Secondary	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.	10 weeks.
Secondary	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.	10 weeks.
Secondary	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.	10 weeks.
Secondary	Skin health score	Measured by the skin health assessment tool at study completion visit and compared to the end of baseline visit.	10 weeks.
Secondary	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.	10 weeks.
Secondary	Quality of life according to the QoL-AD	Measured and scored at completion visit and compared to the end of baseline visit.	10 weeks.
Secondary	Level of agitation and responsive behavior.	Measured via interRAI Aggressive Behavior Scale at study completion visit and compared to the end of baseline visit.	10 weeks.
Secondary	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.	10 weeks.
Secondary	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.	10 weeks.
Secondary	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.	10 weeks.
Secondary	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.	10 weeks.
Secondary	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.	10 weeks
Secondary	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	10 weeks
Secondary	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.	10 weeks.
Secondary	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).	10 weeks.