Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

Not Applicable

Completed

• Conditions: Caregiver Burnout
• Interventions: Behavioral: Automated Bidet; Other: No Intervention

• Registration Number: NCT04283123
• Lead Sponsor: Washington University School of Medicine

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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-25
• Results First Submitted: 2022-11-22
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Results First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Automated Bidet	Participants assigned to this group will receive an automated bidet (TOTO Washlet S300e with remote control) and an occupational therapy intervention over 3-4 in-home visits.
Waitlist Control	No Intervention	Caregivers will wait for 30 days and then will be offered the intervention.

Primary Outcome Measures

Name	Time	Method
Adverse Events	At study completion (2 months [treatment] or 3 months [waitlist control])	Number of adverse events was used with other variables to assess feasibility
Number of Participants Recruited	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	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	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	30 days post-installation	Demonstrate ability to operate the bidet successfully which was used with other variables to assess feasibility
Acceptability	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	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	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	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	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