Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
NCT ID: NCT02042157
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
28 participants
INTERVENTIONAL
2015-01-01
2016-12-31
Brief Summary
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Primary outcome
1. 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).
2. Regular bidet use by adults with impaired functional status will improve the quality of life around toileting for their caregivers.
Secondary
3. Regular bidet use will reduce the incidence, frequency and severity of constipation (as measured by self-report) in adults with impaired functional status.
4. Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult women with impaired functional status.
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Bidet use
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.
Bidet use
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.
Usual Toileting
This group will toilet as usual.
Regular toileting
Patients in the control arm will toilet as usual.
Caregivers of PT in Arm 1 (bidet use)
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.
Bidet use
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.
Caregivers of PT in Arm 2 (usual toileting)
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.
Regular toileting
Patients in the control arm will toilet as usual.
Interventions
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Bidet use
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.
Regular toileting
Patients in the control arm will toilet as usual.
Eligibility Criteria
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Inclusion Criteria
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
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)
21 Years
95 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Mark Cullen
Principal Investigator
Principal Investigators
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Yusra Hussain, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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Related Links
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Search engines for all clinical research taking place at Stanford Medical Center
Portal for Stanford Aging Adult Services
Other Identifiers
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IRB-22588
Identifier Type: -
Identifier Source: org_study_id