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

NCT05247047 | Completed

• 1 other identifier: WHEELS-ONE
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 2

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 weeks.

Secondary Outcomes (18)

• 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.

Study Arms (2)

Device

EXPERIMENTAL

Clusters in this arm will start using the device and use it for 6 weeks.

Device: TENA SmartCare Change Indicator

Control

NO INTERVENTION

Clusters in this arm will not receive the device it will continue with usual care with no changes.

Interventions

TENA SmartCare Change Indicator DEVICE

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.

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2P4, Canada

Location

Hochschule Niederrhein University of Applied Sciences

Krefeld, 47805, Germany

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Wagg, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cluster

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: October 7, 2022
• Primary Completion: December 15, 2023
• Study Completion: January 30, 2024
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CA (1); DE (1)