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临床试验/NCT04283123
NCT04283123已完成不适用

Evaluating the Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

Washington University School of Medicine0 个研究点目标入组 10 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
主要终点
Number of Participants Recruited

研究概览

简要总结

This study evaluates the feasibility, including acceptability and preliminary efficacy, of an automated bidet intervention to make it easier for caregivers to assist with toileting.

详细描述

Informal caregivers provide over 30 billion hours of care to older adults each year. They often assist with toileting tasks which are often identified as one of the most physically and emotionally demanding activities of daily living. Caregivers receive limited training and support which increases their risk for injury and burnout. One potential strategy to reduce or replace the physical support needed from a caregiver is the used of an automated bidet system. It remains unknown whether an automated bidet can be used successfully with older adults and their caregivers at home. The objective of this feasibility study was to assess the acceptability and preliminary efficacy of a toileting intervention using an automated bidet system and training by an occupational therapy practitioner (OT) to reduce the amount of physical assistance required from caregivers.

The investigators will recruit 10 informal caregivers and randomize them to the treatment or waitlist control group. Caregivers in the treatment group will receive the automated bidet right away while those in the waitlist control group will not receive any treatment during that time. After 30 days, both groups will participate in a post-test assessment visit. The waitlist control group will then be offered the intervention and invited to participate in a final session after 30 days to complete assessments and a process evaluation (30 days post follow-up).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) provided unpaid care and lived with a care recipient aged 55 years or older
  • (2) assisted with toileting for at least 6 months
  • (3) did not have an automated bidet
  • (4) had a working toilet and bathroom outlet, and (5) their care recipient was willing to participate

排除标准

  • Caregivers scoring 10 or above on the Short Blessed Test, indicating possible cognitive impairment

结局指标

主要结局

Number of Participants Recruited

时间窗: 5 months

The ability to recruit 10 caregivers who were eligible for the study was used with other variables to assess feasibility

Number of Caregivers Retained

时间窗: At study completion (2 months [treatment] or 3 months [waitlist control])

Retain 10 caregivers was used with other variables to assess feasibility

Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed

时间窗: 30 days post-installation

Installation of the automated bidets and a record of any modifications needed was used with other variables to assess feasibility

Number of Caregivers' or Care Recipients' Who Can Operate the Bidet

时间窗: 30 days post-installation

Demonstrate ability to operate the bidet successfully which was used with other variables to assess feasibility

Acceptability

时间窗: 30 days post-installation

8-item process evaluation: rated on a scale of 0 (strongly disagree) to 4 (strongly agree) with higher scores indicating greater acceptance of the intervention

Preliminary Efficacy: Performance

时间窗: 2 months (treatment) or 3 months (waitlist control)

In-Home Occupational Performance Evaluation for Providing Assistance impact on caregiver outcomes rated on a scale of 1 to 5 with higher scores indicating better performance was used with other variables to assess feasibility

Preliminary Efficacy: Satisfaction

时间窗: 2 months (treatment) or 3 months (waitlist control)

In-Home Occupational Performance Evaluation for Providing Assistance: impact on caregiver outcomes rated on a scale of 1 to 5 with higher scores indicating better satisfaction was used with other variables to assess feasibility

Preliminary Efficacy: Self-efficacy

时间窗: 2 months (treatment) or 3 months (waitlist control)

In-Home Occupational Performance Evaluation for Providing Assistance: impact on caregiver outcomes rated on a scale of 1 to 5 with higher scores indicating better self-efficacy was used with other variables to assess feasibility

Preliminary Efficacy: Physical Environmental Barriers

时间窗: 2 months (treatment) or 3 months (waitlist control)

In-Home Occupational Performance Evaluation for Providing Assistance: reduction of physical barriers to toileting (rated on a scale from 0 (independent) to 5 (no activity/dependent) was used with other variables to assess feasibility

Adverse Events

时间窗: At study completion (2 months [treatment] or 3 months [waitlist control])

Number of adverse events was used with other variables to assess feasibility

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Stark

Associate Professor of Occupational Therapy, Neurology and Social Work

Washington University School of Medicine

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