The effect of the TENA SmartCare Change Indicator on care efficiency and skin health in long term care facilities
Information about the intervention that will be tested in the study
Administration
The medical device is a system consisting of a reusable electronic sensor attached to the outside of the incontinence product and a smartphone application. The system estimates the urine saturation level of an absorbent TENA incontinence product used by a dependent end user. The device intends to assist caregivers in deciding when to change the absorbent incontinence product without manual checks.
Is the intervention already on the market for another medical condition?
No
Will all participants receive the same intervention?
Participants will be selected at random to either receive one of the following options:
- TENA SmartCare Change Indicator
- Continue with usual care (control).
Information about participating in the study
What are the researchers trying to find out?
The purpose of the interventional, post-market clinical investigation is to demonstrate the effect of the TENA SmartCare Change Indicator on care efficiency and skin health of urinary incontinent nursing home residents.
How long will the study last?
About 3 months.
What your involvement will entail?
- The study will be carried out at your nursing home
- There will be in total 4 study visits
- In the study, half of the residents will use the device and the other half will continue with their usual care routine
- Your skin health in the pad area will be checked by someone from the study team at each of their visits
- There will also be a questionnaire where you will be asked to answer questions regarding things you are able to do for yourself and your quality of life
- Information regarding your continence care tasks performed as part of your standard care will be collected by your caregiver.
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be 18 years old and older
- Have urinary incontinence managed with incontinence products with tapes, belted or pull up incontinence product type. It should be products for moderate to heavy incontinencea
- Live in a nursing home (for at least 4 months)
- Be unable to consistently communicate toileting needs
- Be unable to successfully toilet and change the pad without assistance
- Use or is willing to use TENA Slip TENA Flex and TENA Pants absorbing products for the study
- Be a waist size appropriate to the available sizes of incontinence products.
Who cannot participate in the study?
People cannot take part in the study if they have:
- Severe problems with faecal incontinence
- Anuria (no urine production)
- Use of another incontinence management device
- Life expectancy of less than 3 months
- Participation in a recent investigational study of a drug, biologic, or medical device
- History of alcohol and/or substance abuse or dependence.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Clinicaltrials.gov identifier
NCT05247047
Study contact information
Fredrik Agholme +46730323634 fredrik.agholme@essity.com
Arne Böhling +4915221425063 arne.bohling@essity.com
Link to full text
https://clinicaltrials.gov/ct2/show/NCT05247047
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on March 2023.
The pharmaceutical company running this trial has reviewed this document.
