Use of Continence Care Protocol in UK Nursing Homes.

NCT ID: NCT06100458

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-02-02

Brief Summary

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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

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Conditions

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Urinary Incontinence Due to Cognitive Impairment Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Skin and leakage protocol

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lincolnshire Community Health Services NHS Trust

OTHER

Sponsor Role collaborator

Essity Hygiene and Health AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Debbie Jeffrey

Role: PRINCIPAL_INVESTIGATOR

Lincolnshire Community Health Services National Health Services Trust

Locations

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Lincolnshire Community Health Services NHS Trust

Lincoln, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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LASTER

Identifier Type: -

Identifier Source: org_study_id

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