Use of Continence Care Protocol in UK Nursing Homes.

Urinary Incontinence Clinical Trial

Official title:

Use of Skin and Leakage Protocol and Its Impact on Continence Care at Nursing Homes in the UK.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06100458
• Other study ID #: LASTER
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: February 2, 2023

Study information

• Verified date: October 2023
• Source: Essity Hygiene and Health AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective cohort study. In the investigation the clinical use of the Skin and leakage protocol (SLEP) is to be investigated. The SLEP is a generic digital diary form filled out to give information about the current status of continence care among care home residents. The SLEP tracks the number of leakage occurrences and daily skin health over a period of time with the purpose of assisting care staff in making decisions regarding continence care. The SLEP has been introduced at several United kingdom National Health Service care homes and with this investigation the investigators want to retrospectively analyse the data to determine the clinical usefulness of the form.

The primary objective of the study is to describe any changes in product leakage rate at the baseline and follow up time period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is diagnosed with urinary incontinence managed with an absorbing incontinence product.

• The skin and leakage protocol have been used in the care of the subject and there is data from at least two measurements.

• Subject is cared for in a Residential care home using the skin and leakage protocol.

• Subject is over 18 years of age.

Exclusion Criteria:

• Subject is not using an absorbing incontinence product to manage incontinence.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Other:
• Skin and leakage protocol
The skin and leakage protocol have been developed by the sponsor with the aim to offer a tool that can aid care providers in identifying problems in continence care and follow up the effect of any care interventions to remedy these problems. The protocol is a digital diary tool that tracks both the instances of urine leaking out of an absorbing incontinence product onto clothes and bedsheets, and any apparent skin changes in the area covered by the product. The protocol is in clinical use at the care homes were the subjects are residing.

Locations

Country	Name	City	State
United Kingdom	Lincolnshire Community Health Services NHS Trust	Lincoln

Sponsors (2)

Lead Sponsor	Collaborator
Essity Hygiene and Health AB	Lincolnshire Community Health Services NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in leakage rate	Change in absorbing product leakage rate between baseline and follow up period	28 days
Secondary	Subject care profile	The care needs profiles of the subjects using the skin and leakage protocol. According to specific criteria for degree of confusion and mobility subjects can be assigned one of 6 different profiles. The profiles are arranged on a scale from 1-6 were 1 is lowest level of care need and 6 is the highest.	28 days
Secondary	Change in skin health score	Change in skin health assessment score between the baseline and follow up period. The skin assessment is conducted on a scale from 1-5 were 1 represents no presence of skin irritation and 5 represents severe skin problems.	28 days