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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02518321
Other study ID # M16-15-022
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 3, 2015
Last updated August 5, 2015
Start date August 2015
Est. completion date March 2016

Study information

Verified date July 2015
Source Bruyere Research Institute
Contact Hillel Finestone, MD
Phone (613) 562-6094
Email hfinestone@bruyere.org
Is FDA regulated No
Health authority Canada: Ministry of Health & Long Term Care, Ontario
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date March 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

1. over the age of 65

2. inpatients at the EBH GRU

3. can communicate effectively in English or French

4. are able to remain balanced while sitting on a toilet

5. are able to physically use the remote control

6. are able to wipe themselves, but they do not need to be able to wipe themselves effectively

Exclusion Criteria:

1. are cognitively unable to provide informed consent

2. are severely aphasic

3. are undergoing treatment that interferes with toileting

4. have any conditions that increase perineal sensitivity such as ulcers, wounds, or infections

5. require two people to assist them in transferring to and from the toilet

6. are under isolation precautions

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Technology-Assisted Toileting


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Bruyere Research Institute Bruyère Academic Medical Organization, TOTO USA, University of Ottawa

Outcome

Type Measure Description Time frame Safety issue
Primary Psychosocial Impact of Assistive Devices Scale (PIADS) Scale used to assess participants' subjective feelings of adaptability, competence, and self-esteem up to 12 weeks No
Primary Cleanliness Scale A new scale being piloted to measure cleanliness of the anal/genital regions up to 12 weeks No
See also
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