Use of Continence Care Protocol in UK Nursing Homes.

NCT06100458 | Completed

• 1 other identifier: LASTER
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence Due to Cognitive Impairment; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Change in leakage rate

  Change in absorbing product leakage rate between baseline and follow up period

  28 days

Secondary Outcomes (2)

• Subject care profile

  28 days

• Change in skin health score

  28 days

Study Arms (1)

Protocol arm

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.

Other: Skin and leakage protocol

Interventions

Skin and leakage protocol OTHER

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.

Protocol arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects to be evaluated will be subjects of the selected Care homes who meet all the required Inclusion and Exclusion criteria and who's data is available on the appropriate databases. Subjects will be considered eligible to participate in the study if: All eligible subjects, that data is available for, cared for at the selected care homes and subjected to the protocol are to be assessed. Typically, all residents that use containment products are assessed at the care home.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead
• Lincolnshire Community Health Services NHS Trust: collaborator

Study Sites (1)

Lincolnshire Community Health Services NHS Trust

Lincoln, LN5 7JH, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Debbie Jeffrey

  Lincolnshire Community Health Services National Health Services Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 25, 2023
• Study Start: December 1, 2022
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

GB (1)