Use of Continence Care Protocol in UK Nursing Homes.

Completed

• Conditions: Urinary Incontinence; Urinary Incontinence Due to Cognitive Impairment
• Interventions: Other: Skin and leakage protocol

• Registration Number: NCT06100458
• Lead Sponsor: Essity Hygiene and Health AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-02-02
• Study Completion: 2023-02-02
• Status Verified: 2023-10
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Protocol arm	Skin and leakage protocol	The skin and leakage protocol was used over a 5 day baseline period. The follow up was done 25 days later by another 5 day period of protocol use to observe any changes in continence care.

Primary Outcome Measures

Name	Time	Method
Change in leakage rate	28 days	Change in absorbing product leakage rate between baseline and follow up period

Secondary Outcome Measures

Name	Time	Method
Change in skin health score	28 days	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.
Subject care profile	28 days	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.

Trial Locations

Locations (1)

Lincolnshire Community Health Services NHS Trust; 🇬🇧 Lincoln, United Kingdom