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Use of Continence Care Protocol in UK Nursing Homes.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06100458
Enrollment
49
Registered
2023-10-25
Start date
2022-12-01
Completion date
2023-02-02
Last updated
2023-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence, Urinary Incontinence Due to Cognitive Impairment

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.

Interventions

OTHERSkin 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.

Sponsors

Lincolnshire Community Health Services NHS Trust
CollaboratorOTHER
Essity Hygiene and Health AB
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in leakage rate28 daysChange in absorbing product leakage rate between baseline and follow up period

Secondary

MeasureTime frameDescription
Subject care profile28 daysThe 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.
Change in skin health score28 daysChange 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026