Urinary Incontinence Due to Cognitive ImpairmentNCT06100458
Use of Continence Care Protocol in UK Nursing Homes.
An observational study of Urinary Incontinence Due to Cognitive Impairment and Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence Due to Cognitive Impairment, Urinary Incontinence
- What is being tested?
- Skin and leakage protocol
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2022to 2 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subject is not using an absorbing incontinence product to manage incontinence.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lincolnshire Community Health Services NHS Trust
Lincoln, LN5 7JH
About this study
Official title: Use of Skin and Leakage Protocol and Its Impact on Continence Care at Nursing Homes in the UK.
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.
- Being tested
- Skin and leakage protocol
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin and leakage protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Skin and leakage protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in leakage rate
Change in absorbing product leakage rate between baseline and follow up period
Measured: 28 days
Secondary outcomes (2)
Subject care profile
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.
Measured: 28 days
Change in skin health score
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Dec 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence Due to Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lincolnshire Community Health Services NHS Trust
- Responsible party
- Sponsor
- Investigators
- Debbie Jeffrey, Principal investigator, Lincolnshire Community Health Services National Health Services Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100458
- Sponsor's protocol ID
- LASTER
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Skin and Leakage Protocol and Its Impact on Continence Care at Nursing Homes in the UK.
- ClinicalTrials.gov ID
- NCT06100458
- Acronym / sponsor ID
- LASTER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Collaborators
- Lincolnshire Community Health Services NHS Trust
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protocol arm | – | Other: Skin and leakage protocolThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Subject is not using an absorbing incontinence product to manage incontinence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin and leakage protocolThe 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. | Other | Protocol arm |
Primary outcome
Change in leakage rate
Time frame: 28 days
Change in absorbing product leakage rate between baseline and follow up period
2 secondary outcomes
Subject care profile
Time frame: 28 days
Change in skin health score
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debbie Jeffrey principal investigator
Lincolnshire Community Health Services National Health Services Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence Due to Cognitive Impairment and Urinary Incontinence, run by Essity Hygiene and Health AB at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in leakage rate (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.