Skip to main content
OpenTrials
Completed

NCT Number: NCT05247047

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Care Efficiency score

    Time frame: 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.

  2. Daily Skin Health score

    Time frame: 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.

Secondary outcomes

  1. Number of continence care product checks

    Time frame: 10 weeks.

    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.

  2. Number of continence care product changes

    Time frame: 10 weeks.

    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.

  3. Number of continence care toilet visits

    Time frame: 10 weeks.

    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.

  4. Number of continence care clothing changes

    Time frame: 10 weeks.

    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.

  5. Number of continence care bed linen changes

    Time frame: 10 weeks.

    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.

  6. The time spent on continence care episodes

    Time frame: 10 weeks.

    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.

  7. Skin health score

    Time frame: 10 weeks.

    Measured by the skin health assessment tool at study completion visit and compared to the end of baseline visit.

  8. Quality of life and level of utility

    Time frame: 10 weeks.

    Measured using the EQ-5D-5L questionnaire at study completion visit and compared to the end of baseline visit.

  9. Quality of life according to the QoL-AD

    Time frame: 10 weeks.

    Measured and scored at completion visit and compared to the end of baseline visit.

  10. Level of agitation and responsive behavior.

    Time frame: 10 weeks.

    Measured via interRAI Aggressive Behavior Scale at study completion visit and compared to the end of baseline visit.

  11. Number of sleep interruptions due to continence care

    Time frame: 10 weeks.

    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.

  12. Total absorption value

    Time frame: 10 weeks.

    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.

  13. Caregiver work engagement

    Time frame: 10 weeks.

    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.

  14. Caregiver work conditions

    Time frame: 10 weeks.

    Measured using the organizational headroom questionnaire at a cluster's end-of-trial visit and compared to the end of baseline visit.

  15. Time spent in a saturated continence care product

    Time frame: 10 weeks

    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.

  16. Number of unnecessary checks.

    Time frame: 10 weeks

    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.

  17. Qualitative data on implementation, uptake, opportunities and barriers to use.

    Time frame: 10 weeks.

    Response to interviews with caregivers, coded by the investigator and collated into trends and themes. Conducted after completion of study for subjects.

  18. Safety data for the device.

    Time frame: 10 weeks.

    Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), serious adverse device effects (SADE), and device deficiency (DD).

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 18, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.