- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05626062
Toilet Training and Adults With Learning Disabilities
November 15, 2022 updated by: Glasgow Caledonian University
Toileting Assessment and Toilet Training for Adults With Learning Disabilities With Incontinence
Incontinence is common in adults with learning disabilities (LDs).
Behavioural toilet training in conjunction with toilet alarms is recommended for people with LDs, but there is a paucity of research, thus evidence-based practise, on behavioural toilet training for adults with LDs.
The aim of this study is to assess the toileting needs and issues of 30 adults with LDs with incontinence, and determine whether a 12-week individualised positive behavioural support training intervention, with the use of toilet alarms, promotes continence.
Study Overview
Detailed Description
Adults with learning disabilities with incontinence are being invited to participate in a 12-week personalised, positive toilet training plan, following assessment of their toileting needs.
Primary outcome measures will be: number of incidences of incontinence, and number of instances of successful voiding in a toilet.
Toilet alarms will be used to encourage prompted voiding in a toilet.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lanarkshire
-
Glasgow, Lanarkshire, United Kingdom, G4 0BA
- Recruiting
- Glasgow Caledonian University
-
Contact:
- Janet Finlayson, PHD
- Phone Number: 0141 331 3083
- Email: Janet.Finlayson@gcu.ac.uk
-
-
Scotland
-
Glasgow, Scotland, United Kingdom, G4 0BA
- Recruiting
- Glasgow Caledonian University
-
Contact:
- Janet Finlayson, PHD
- Phone Number: 0141 331 3083
- Email: Janet.Finlayson@gcu.ac.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults with learning disabilities with incontince across all levels of learning disabilities (mild to profound)
Exclusion Criteria:
- Cannot sit on a toilet for up to 3 minutes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
30 adults with learning disabilities with incontinence will be offered a 12-week personalised toilet training plan, which promotes prompted voiding in a toilet
|
A Malem toilet alarm (wristworn, discretely in underwear, or bed mat) will be used to promote prompred voiding in a toilet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of instances of incontinence
Time Frame: 12 weeks
|
The intervention should promote less instances of incontinence
|
12 weeks
|
Number of instances of successful voiding in a toilet
Time Frame: 12 weeks
|
The intervention should promote more instances of successful voiding in a toilet
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2022
Primary Completion (Anticipated)
September 27, 2023
Study Completion (Anticipated)
November 27, 2023
Study Registration Dates
First Submitted
November 15, 2022
First Submitted That Met QC Criteria
November 15, 2022
First Posted (Actual)
November 23, 2022
Study Record Updates
Last Update Posted (Actual)
November 23, 2022
Last Update Submitted That Met QC Criteria
November 15, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R4451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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