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Completed

NCT Number: NCT06100458

Use of Continence Care Protocol in UK Nursing Homes.

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.

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Key information

Conditions

Urinary Incontinence Due to Cognitive Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lincolnshire Community Health Services NHS Trust

Lincoln, LN5 7JH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in leakage rate

    Time frame: 28 days

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

Secondary outcomes

  1. Subject care profile

    Time frame: 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.

  2. Change in skin health score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Collaborators

  • Lincolnshire Community Health Services NHS Trust

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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