- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02518321
Can Technology-Assisted Toilets Improve Hygiene and Independence in Geriatric Rehabilitation? A Cohort Study
Toileting is a private activity of daily living. Geriatric rehabilitation patients are often unable to toilet themselves independently, leading to embarrassment and loss of self-esteem. Relationships with their caregivers may also become strained. Furthermore, improper toileting hygiene can lead to skin irritation, breakdown and infection.
Technology-assisted toilets (TATs) clean and dry the anal and vaginal regions using a stream of water and a fan. They can therefore potentially eliminate the need for patients to be able to wipe themselves. TATs are operated using wall-mounted remote controls. This study will examine the potential benefits of TAT use in geriatric rehabilitation patients.
Forty patients aged ≥65 years referred for treatment of physical impairments to the Geriatric Rehabilitation Unit (GRU) of the Elisabeth Bruyère Hospital (EBH) will be recruited for this study. Participants will have a bowel movement on two occasions, once using toilet paper and once using the TAT. The Psychosocial Impact of Assistive Devices Scale (PIADS), a validated questionnaire, will be used to analyze participants' toileting experience. Participants will be visually evaluated for cleanliness before and after each testing session.
The investigators hypothesize that participants will report that, in comparison with use of a standard toilet, toileting using the TAT: 1) is easier to use, 2) improves psychological well-being and 3) is more effective at cleaning than regular wiping techniques.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hillel Finestone, MD
- Phone Number: (613) 562-6094
- Email: hfinestone@bruyere.org
Study Contact Backup
- Name: David Yachnin, BA
- Phone Number: 6133149017
- Email: dyachnin@bruyere.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- over the age of 65
- inpatients at the EBH GRU
- can communicate effectively in English or French
- are able to remain balanced while sitting on a toilet
- are able to physically use the remote control
- are able to wipe themselves, but they do not need to be able to wipe themselves effectively
Exclusion Criteria:
- are cognitively unable to provide informed consent
- are severely aphasic
- are undergoing treatment that interferes with toileting
- have any conditions that increase perineal sensitivity such as ulcers, wounds, or infections
- require two people to assist them in transferring to and from the toilet
- are under isolation precautions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard Toileting First
This group will complete the standard toileting trial before the TAT toileting trial.
|
Other Names:
|
Experimental: TAT Toileting First
This group will complete the TAT toileting trial before the standard toileting trial.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychosocial Impact of Assistive Devices Scale (PIADS)
Time Frame: up to 12 weeks
|
Scale used to assess participants' subjective feelings of adaptability, competence, and self-esteem
|
up to 12 weeks
|
Cleanliness Scale
Time Frame: up to 12 weeks
|
A new scale being piloted to measure cleanliness of the anal/genital regions
|
up to 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hillel Finestone, MD, Bruyère Continuing Care, Bruyère Research Institute, Elisabeth Bruyère Hospital, University of Ottawa.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- M16-15-022
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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