Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

August 25, 2025 updated by: Susan Stark, Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Waitlist Control
Caregivers will wait for 30 days and then will be offered the intervention.
Waitlist control
Experimental: Treatment
Participants assigned to this group will receive an automated bidet (TOTO Washlet S300e with remote control) and an occupational therapy intervention over 2-3 in-home visits.
During the first intervention visit, a licensed contractor will install the bidets in participants' homes. The OT will then educate and train the caregiver and care recipient to successfully use the bidet, and make any modifications to the remote as needed. Throughout the intervention, the OT will use motivational enhancement strategies. The OT will make minor modifications to the remote as needed. A second intervention visit will occur 1-2 weeks post-installation to address any new difficulties. Check-in phone calls will be offered to the caregiver and care recipient if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 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
30 days post-installation
Number of Participants Recruited
Time Frame: 5 months
The ability to recruit 10 caregivers who were eligible for the study was used with other variables to assess feasibility
5 months
Number of Caregivers Retained
Time Frame: At study completion (2 months [treatment] or 3 months [waitlist control])
Retain 10 caregivers was used with other variables to assess feasibility
At study completion (2 months [treatment] or 3 months [waitlist control])
Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed
Time Frame: 30 days post-installation
Installation of the automated bidets and a record of any modifications needed was used with other variables to assess feasibility
30 days post-installation
Number of Caregivers' or Care Recipients' Who Can Operate the Bidet
Time Frame: 30 days post-installation
Demonstrate ability to operate the bidet successfully which was used with other variables to assess feasibility
30 days post-installation
Preliminary Efficacy: Performance
Time Frame: 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
2 months (treatment) or 3 months (waitlist control)
Preliminary Efficacy: Satisfaction
Time Frame: 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
2 months (treatment) or 3 months (waitlist control)
Preliminary Efficacy: Self-efficacy
Time Frame: 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
2 months (treatment) or 3 months (waitlist control)
Preliminary Efficacy: Physical Environmental Barriers
Time Frame: 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
2 months (treatment) or 3 months (waitlist control)
Adverse Events
Time Frame: At study completion (2 months [treatment] or 3 months [waitlist control])
Number of adverse events was used with other variables to assess feasibility
At study completion (2 months [treatment] or 3 months [waitlist control])

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susan Stark, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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