Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Improved quality of life as measured QoL questionnaire
研究概览
简要总结
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 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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Bidet use (Behavioral)
Usual Toileting
This group will toilet as usual.
干预措施: Regular toileting (Other)
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.
干预措施: Bidet use (Behavioral)
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.
干预措施: Regular toileting (Other)
结局指标
主要结局
Improved quality of life as measured QoL questionnaire
时间窗: 24 months
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.
时间窗: 24 months
We will measure caregiver burden using a validated instrument.
次要结局
- Incidence of UTI as measured by enquiry and chart review (female patients only).(24 months)
- Incidence of constipation as measured by self report(24 months)
- Severity (measured by self report) of constipation(24 months)
研究者
Mark Cullen
Principal Investigator
Stanford University