NCT02518321

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 7, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

July 3, 2015

Last Update Submit

August 5, 2015

Conditions

Keywords

ToiletingTechnology-Assisted ToiletsRehabilitationAssistive DevicesActivities of Daily Living

Outcome Measures

Primary Outcomes (2)

  • Psychosocial Impact of Assistive Devices Scale (PIADS)

    Scale used to assess participants' subjective feelings of adaptability, competence, and self-esteem

    up to 12 weeks

  • Cleanliness Scale

    A new scale being piloted to measure cleanliness of the anal/genital regions

    up to 12 weeks

Study Arms (2)

Standard Toileting First

EXPERIMENTAL

This group will complete the standard toileting trial before the TAT toileting trial.

Device: Technology-Assisted Toileting

TAT Toileting First

EXPERIMENTAL

This group will complete the TAT toileting trial before the standard toileting trial.

Device: Technology-Assisted Toileting

Interventions

Also known as: bidet toilets, smart toilets, TOTO Washlet
Standard Toileting FirstTAT Toileting First

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hillel Finestone, MD

    Bruyère Continuing Care, Bruyère Research Institute, Elisabeth Bruyère Hospital, University of Ottawa.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hillel Finestone, MD

CONTACT

David Yachnin, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2015

First Posted

August 7, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

August 7, 2015

Record last verified: 2015-07