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Toilet Training and Adults With Learning Disabilities

Primary Purpose

Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Toilet alarm
Sponsored by
Glasgow Caledonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Incontinence, Learning disabilities

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Glasgow Caledonian UniversityRecruiting
  • Glasgow Caledonian UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

30 adults with learning disabilities with incontinence will be offered a 12-week personalised toilet training plan, which promotes prompted voiding in a toilet

Outcomes

Primary Outcome Measures

Number of instances of incontinence
The intervention should promote less instances of incontinence
Number of instances of successful voiding in a toilet
The intervention should promote more instances of successful voiding in a toilet

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
November 15, 2022
Sponsor
Glasgow Caledonian University
Collaborators
University of Kent
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1. Study Identification

Unique Protocol Identification Number
NCT05626062
Brief Title
Toilet Training and Adults With Learning Disabilities
Official Title
Toileting Assessment and Toilet Training for Adults With Learning Disabilities With Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2022 (Actual)
Primary Completion Date
September 27, 2023 (Anticipated)
Study Completion Date
November 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glasgow Caledonian University
Collaborators
University of Kent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Incontinence, Learning disabilities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A feasibility sample of 30 adults with learning disabilities with incontinence
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
30 adults with learning disabilities with incontinence will be offered a 12-week personalised toilet training plan, which promotes prompted voiding in a toilet
Intervention Type
Device
Intervention Name(s)
Toilet alarm
Intervention Description
A Malem toilet alarm (wristworn, discretely in underwear, or bed mat) will be used to promote prompred voiding in a toilet
Primary Outcome Measure Information:
Title
Number of instances of incontinence
Description
The intervention should promote less instances of incontinence
Time Frame
12 weeks
Title
Number of instances of successful voiding in a toilet
Description
The intervention should promote more instances of successful voiding in a toilet
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Glasgow Caledonian University
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G4 0BA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Finlayson, PhD
Phone
0141 331 3083
Email
Janet.Finlayson@gcu.ac.uk
Facility Name
Glasgow Caledonian University
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0BA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Finlayson, PHD
Phone
0141 331 3083
Email
Janet.Finlayson@gcu.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Toilet Training and Adults With Learning Disabilities

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