Can Technology-Assisted Toilets Improve Hygiene and Indep... | NCT02518321

Studies
Can Technology-Assisted Toilets Improve Hygiene and Independence in Geriatric Rehabilitation? A Cohort Study

NCT02518321

Sponsor

Bruyère Health Research Institute.

Status

Unknown status

Last Update Posted

Aug 7, 2015Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Geriatric Rehabilitation

Interventions

Technology-Assisted Toileting

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Jul 3, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2015

Last Update Posted Date

Aug 7, 2015Estimated

Name	Class
University of Ottawa	OTHER
Bruyère Academic Medical Organization	UNKNOWN
TOTO USA	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Technology-Assisted Toileting	Device		Standard Toileting First TAT Toileting First	bidet toilets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hillel Finestone, MD	Contact	(613) 562-6094		hfinestone@bruyere.org
David Yachnin, BA	Contact	6133149017		dyachnin@bruyere.com

Overall Officials

Name	Affiliation	Role
Hillel Finestone, MD	Bruyère Continuing Care, Bruyère Research Institute, Elisabeth Bruyère Hospital, University of Ottawa.	Principal Investigator

Locations

Not provided