Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

NCT04283123 | Completed Results

• 1 other identifier: 201610044
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Caregiver Burnout

Keywords

Assistive Technology; Informal Caregivers; Occupational Therapy; Toileting

Outcome Measures

Primary Outcomes (10)

• Number of Participants Recruited

  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

  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

  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

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

  30 days post-installation

• Acceptability

  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

• Preliminary Efficacy: Performance

  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

  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

  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

  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

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

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

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Behavioral: Automated Bidet

Waitlist Control

ACTIVE COMPARATOR

Caregivers will wait for 30 days and then will be offered the intervention.

Other: No Intervention

Interventions

Automated Bidet BEHAVIORAL

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.

Treatment

No Intervention OTHER

Waitlist control

Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Susan Stark, PhD, OTR/L, FAOTA
• Organization: Washington University School of Medicine in St. Louis

sstark@wustl.edu

(314)273-4114

Study Officials

• Susan Stark, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Occupational Therapy, Neurology and Social Work

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 25, 2020
• Study Start: December 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 27, 2025
• Results First Posted: November 20, 2024

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share