Use of Continence Care Protocol in UK Nursing Homes.

Sponsor
Essity Hygiene and Health AB (Industry)
Overall Status
Completed
CT.gov ID
NCT06100458
Collaborator
Lincolnshire Community Health Services NHS Trust (Other)
49
1
2.1
23.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Skin and leakage protocol

Study Design

Study Type:
Observational
Actual Enrollment :
49 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Use of Skin and Leakage Protocol and Its Impact on Continence Care at Nursing Homes in the UK.
Actual Study Start Date :
Dec 1, 2022
Actual Primary Completion Date :
Feb 2, 2023
Actual Study Completion Date :
Feb 2, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Change in leakage rate [28 days]

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

Secondary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lincolnshire Community Health Services NHS Trust Lincoln United Kingdom LN5 7JH

Sponsors and Collaborators

  • Essity Hygiene and Health AB
  • Lincolnshire Community Health Services NHS Trust

Investigators

  • Principal Investigator: Debbie Jeffrey, Lincolnshire Community Health Services National Health Services Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Essity Hygiene and Health AB
ClinicalTrials.gov Identifier:
NCT06100458
Other Study ID Numbers:
  • LASTER
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2023