Clinical trial NCT05247047: The Effect of the TENA SmartCare Change Indicator on Care Efficiency and Skin Health in Long Term Care Facilities
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Essity Hygiene and Health AB
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Care Efficiency score
timeFrame: 10 weeks.
measure: Daily Skin Health score
timeFrame: 10 weeks.
Secondary outcomes:
measure: Number of continence care product checks
timeFrame: 10 weeks.
measure: Number of continence care product changes
timeFrame: 10 weeks.
measure: Number of continence care toilet visits
timeFrame: 10 weeks.
measure: Number of continence care clothing changes
timeFrame: 10 weeks.
measure: Number of continence care bed linen changes
timeFrame: 10 weeks.
measure: The time spent on continence care episodes
timeFrame: 10 weeks.
measure: Skin health score
timeFrame: 10 weeks.
measure: Quality of life and level of utility
timeFrame: 10 weeks.
measure: Quality of life according to the QoL-AD
timeFrame: 10 weeks.
measure: Level of agitation and responsive behavior.
timeFrame: 10 weeks.
measure: Number of sleep interruptions due to continence care
timeFrame: 10 weeks.
measure: Total absorption value
timeFrame: 10 weeks.
measure: Caregiver work engagement
timeFrame: 10 weeks.
measure: Caregiver work conditions
timeFrame: 10 weeks.
measure: Time spent in a saturated continence care product
timeFrame: 10 weeks
measure: Number of unnecessary checks.
timeFrame: 10 weeks
measure: Qualitative data on implementation, uptake, opportunities and barriers to use.
timeFrame: 10 weeks.
measure: Safety data for the device.
timeFrame: 10 weeks.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Krefeld
country: Germany
facility: Hochschule Niederrhein University of Applied Sciences
Study officials:
affiliation: University of Alberta
name: Adrian Wagg, MD
role: PRINCIPAL_INVESTIGATOR
References: