Caregiver Burden for Those Who Care for Adults With Impaired Functional Status Clinical Trial
Official title:
Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
| Verified date | October 2017 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Our expectations (hypotheses) are:
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.
| Status | Terminated |
| Enrollment | 28 |
| Est. completion date | December 31, 2016 |
| Est. primary completion date | December 31, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years to 95 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Stanford University School of Medicine | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 24 months | |
| Primary | 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. | 24 months | |
| Secondary | 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. |
24 months | |
| Secondary | Incidence of constipation as measured by self report | We will ask patients on a monthly basis if they have had constipation. | 24 months | |
| Secondary | 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. | 24 months |