Geriatric RehabilitationNCT02518321
Can Technology-Assisted Toilets Improve Hygiene and Independence in Geriatric Rehabilitation? A Cohort Study
A study testing Technology-Assisted Toileting in people with Geriatric Rehabilitation, run by Bruyère Health Research Institute..
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Rehabilitation
- What is being tested?
- Technology-Assisted Toileting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this 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.
Read more
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.
- Conditions
- Geriatric Rehabilitation
- Being tested
- Technology-Assisted Toileting
- Keywords
- Toileting, Technology-Assisted Toilets, Rehabilitation, Assistive Devices, Activities of Daily Living
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Assisted ToiletingDevice
Also called bidet toilets, smart toilets, TOTO Washlet
| Study group | Role | What they receive |
|---|---|---|
| Standard Toileting First | Experimental | This group will complete the standard toileting trial before the TAT toileting trial. Receives: Device: Technology-Assisted Toileting |
| TAT Toileting First | Experimental | This group will complete the TAT toileting trial before the standard toileting trial. Receives: Device: Technology-Assisted Toileting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial Impact of Assistive Devices Scale (PIADS)
Scale used to assess participants' subjective feelings of adaptability, competence, and self-esteem
Measured: up to 12 weeks
Cleanliness Scale
A new scale being piloted to measure cleanliness of the anal/genital regions
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa, Bruyère Academic Medical Organization, TOTO USA
- Responsible party
- Sponsor
- Investigators
- Hillel Finestone, MD, Principal investigator, Bruyère Continuing Care, Bruyère Research Institute, Elisabeth Bruyère Hospital, University of Ottawa.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518321
- Sponsor's protocol ID
- M16-15-022
- Status last verified
- Jul 2015
- First submitted
- 3 Jul 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Technology-Assisted Toilets Improve Hygiene and Independence in Geriatric Rehabilitation? A Cohort Study
- ClinicalTrials.gov ID
- NCT02518321
- Acronym / sponsor ID
- M16-15-022
- Conditions
- Geriatric Rehabilitation
- Keywords
- Toileting, Technology-Assisted Toilets, Rehabilitation, Assistive Devices, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- University of Ottawa, Bruyère Academic Medical Organization, TOTO USA
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Toileting First | Experimental | Device: Technology-Assisted ToiletingThis group will complete the standard toileting trial before the TAT toileting trial. |
| TAT Toileting First | Experimental | Device: Technology-Assisted ToiletingThis group will complete the TAT toileting trial before the standard toileting trial. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-Assisted ToiletingAlso: bidet toilets, smart toilets, TOTO Washlet | Device | Standard Toileting First, TAT Toileting First |
Primary outcome
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
Cleanliness Scale
Time frame: up to 12 weeks
A new scale being piloted to measure cleanliness of the anal/genital regions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hillel Finestone, MD principal investigator
Bruyère Continuing Care, Bruyère Research Institute, Elisabeth Bruyère Hospital, University of Ottawa.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Assisted Toileting in people with Geriatric Rehabilitation, run by Bruyère Health Research Institute..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hillel Finestone, MD ((613) 562-6094, hfinestone@bruyere.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial Impact of Assistive Devices Scale (PIADS) (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.