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Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting

Primary Purpose

Toileting in Adults With Impaired Functional Status, Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, UTI in Adults With Impaired Functional Status

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bidet use
Regular toileting
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Toileting in Adults With Impaired Functional Status focused on measuring Quality of Life, Caregivers, Caregiver burden, Urinary Tract Infections, Bidet, Women's health, Toileting, Hygiene, Activities of Daily Living, Functional impairment, Geriatrics

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Sample 1 (adults with impaired functional status):

Age: 55-95 Sex: Female Ethic background: Reflecting the population at Stanford Hospital and Clinics who meet the inclusion criteria and who agree to participate.

Sample 2 (caregivers of participants in Sample 1) Adults over the age of 21 caring for an adult with impaired functional status who has enrolled in this randomized controlled trial. Sex and ethnic background will reflect the demographic of the caregivers for the population in Sample 1.

Exclusion Criteria:

Participants not meeting the inclusion criteria.

Additional exclusion criteria:

  1. Life expectancy less than 2 years
  2. The inability to read and write English.
  3. Patients with indwelling urinary (e.g. Foley) catheters
  4. Use of any water based cleaning system after toileting at home in the past 12 months (bidet, water pot, douche etc).
  5. Fully incontinent (eg diaper use)
  6. Moderate to severe cognitive impairment (15 or lower on the MOCA)

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Bidet use

Usual Toileting

Caregivers of PT in Arm 1 (bidet use)

Caregivers of PT in Arm 2 (usual toileting)

Arm Description

This arm will have a bidet installed in their home bathroom and be instructed how to use it. This arm will use the bidet for usual toileting for a period of two years.

This group will toilet as usual.

Participants with functional impairment will be randomized into one of two arms (bidet use or usual toileting). Their caregivers will be enrolled and their randomization is "bundled" with the study participant who they care for. This arm will care for participants who have been randomized to bidet.

Participants with functional impairment will be randomized into one of two arms (bidet use or usual toileting). Their caregivers will be enrolled and their randomization is "bundled" with the study participant who they care for. This arm will care for participants who have been randomized to usual toileting.

Outcomes

Primary Outcome Measures

Improved quality of life as measured QoL questionnaire
We are measuring the quality of life using a validated QoL questionnaire which has been slightly modified to include questions around toileting.
Caregiver burden for caregivers of adults with functional limitations as measured by a validated caregiver burden questionnaire.
We will measure caregiver burden using a validated instrument.

Secondary Outcome Measures

Incidence of UTI as measured by enquiry and chart review (female patients only).
Every month we will screen female patients in both arms of the study to ask them if they have had any symptoms of UTI or sought medical attention for UTI. We will also review their chart for diagnosis of UTI or prescription of a medication for UTI. Either self-report of a diagnosis or prescription for a medication of a UTI or a report of UTI in the chart will be considered an incidence of UTI.
Incidence of constipation as measured by self report
We will ask patients on a monthly basis if they have had constipation.
Severity (measured by self report) of constipation
For those patients who report having had constipation, will ask them to rate the severity of their constipation on a monthly basis.

Full Information

First Posted
January 17, 2014
Last Updated
October 17, 2017
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02042157
Brief Title
Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
Official Title
Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Equipment malfunction.
Study Start Date
January 1, 2015 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Our expectations (hypotheses) are: Primary outcome Regular bidet use will improve quality of life around elimination in adults with impaired functional status. Functional status will be measured by activities of daily living (ADL). Regular bidet use by adults with impaired functional status will improve the quality of life around toileting for their caregivers. Secondary Regular bidet use will reduce the incidence, frequency and severity of constipation (as measured by self-report) in adults with impaired functional status. Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult women with impaired functional status.
Detailed Description
The study will assess the use of a bidet (a device that is attached to the toilet which allows a person to wash their genitalia after elimination) in improving toilet related quality of life for functionally impaired individuals as measured by ADLs and caregivers of functionally impaired adults. We also want to see if bidet use is effective in lowering the incidence of urinary tract infections in this high risk population. Functional impairment around toileting has been shown to negatively impact quality of life (QOL) for both patients and their caregivers. We hope to learn if the use of bidet will improve QOL in this population. Urinary tract infections increase the risk of morbidity and mortality in women with impaired functional status. Specifically the risk of hospitalization, sepsis, kidney failure and other complications. There are not currently effective forms of non-pharmaceutical prevention. Bidets are safe, inexpensive and hygienic. Individuals with functional impairment often have difficulty maintaining their hygiene due to frailty and functional limitations. It is our hope that addressing these issues will lead to a reduced incidence of UTI. Constipation is a common problem in elderly adults and in adults with impaired functional status. It is our hope that the bidet will reduce the frequency and severity of constipation (as measured by self report).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toileting in Adults With Impaired Functional Status, Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, UTI in Adults With Impaired Functional Status
Keywords
Quality of Life, Caregivers, Caregiver burden, Urinary Tract Infections, Bidet, Women's health, Toileting, Hygiene, Activities of Daily Living, Functional impairment, Geriatrics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bidet use
Arm Type
Experimental
Arm Description
This arm will have a bidet installed in their home bathroom and be instructed how to use it. This arm will use the bidet for usual toileting for a period of two years.
Arm Title
Usual Toileting
Arm Type
Placebo Comparator
Arm Description
This group will toilet as usual.
Arm Title
Caregivers of PT in Arm 1 (bidet use)
Arm Type
Experimental
Arm Description
Participants with functional impairment will be randomized into one of two arms (bidet use or usual toileting). Their caregivers will be enrolled and their randomization is "bundled" with the study participant who they care for. This arm will care for participants who have been randomized to bidet.
Arm Title
Caregivers of PT in Arm 2 (usual toileting)
Arm Type
Placebo Comparator
Arm Description
Participants with functional impairment will be randomized into one of two arms (bidet use or usual toileting). Their caregivers will be enrolled and their randomization is "bundled" with the study participant who they care for. This arm will care for participants who have been randomized to usual toileting.
Intervention Type
Behavioral
Intervention Name(s)
Bidet use
Intervention Description
Participants used a bidet, a device installed on the toilet that provides fresh water to help clean the bottom and genitalia after having a bowel movement or urinating.
Intervention Type
Other
Intervention Name(s)
Regular toileting
Intervention Description
Patients in the control arm will toilet as usual.
Primary Outcome Measure Information:
Title
Improved quality of life as measured QoL questionnaire
Description
We are measuring the quality of life using a validated QoL questionnaire which has been slightly modified to include questions around toileting.
Time Frame
24 months
Title
Caregiver burden for caregivers of adults with functional limitations as measured by a validated caregiver burden questionnaire.
Description
We will measure caregiver burden using a validated instrument.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Incidence of UTI as measured by enquiry and chart review (female patients only).
Description
Every month we will screen female patients in both arms of the study to ask them if they have had any symptoms of UTI or sought medical attention for UTI. We will also review their chart for diagnosis of UTI or prescription of a medication for UTI. Either self-report of a diagnosis or prescription for a medication of a UTI or a report of UTI in the chart will be considered an incidence of UTI.
Time Frame
24 months
Title
Incidence of constipation as measured by self report
Description
We will ask patients on a monthly basis if they have had constipation.
Time Frame
24 months
Title
Severity (measured by self report) of constipation
Description
For those patients who report having had constipation, will ask them to rate the severity of their constipation on a monthly basis.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sample 1 (adults with impaired functional status): Age: 55-95 Sex: Female Ethic background: Reflecting the population at Stanford Hospital and Clinics who meet the inclusion criteria and who agree to participate. Sample 2 (caregivers of participants in Sample 1) Adults over the age of 21 caring for an adult with impaired functional status who has enrolled in this randomized controlled trial. Sex and ethnic background will reflect the demographic of the caregivers for the population in Sample 1. Exclusion Criteria: Participants not meeting the inclusion criteria. Additional exclusion criteria: Life expectancy less than 2 years The inability to read and write English. Patients with indwelling urinary (e.g. Foley) catheters Use of any water based cleaning system after toileting at home in the past 12 months (bidet, water pot, douche etc). Fully incontinent (eg diaper use) Moderate to severe cognitive impairment (15 or lower on the MOCA)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yusra Hussain, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Links:
URL
http://med.stanford.edu/clinicaltrials/
Description
Search engines for all clinical research taking place at Stanford Medical Center
URL
http://stanfordhospital.org/forPatients/patientServices/agingAdults/
Description
Portal for Stanford Aging Adult Services

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Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting

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