Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

NCT ID: NCT04283123

Last Updated: 2025-08-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-06-30

Brief Summary

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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

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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).

Conditions

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Caregiver Burnout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Automated Bidet

Intervention Type 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.

Waitlist Control

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

Group Type ACTIVE_COMPARATOR

No Intervention

Intervention Type OTHER

Waitlist control

Interventions

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Automated Bidet

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.

Intervention Type BEHAVIORAL

No Intervention

Waitlist control

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Susan Stark

Associate Professor of Occupational Therapy, Neurology and Social Work

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Stark, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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201610044

Identifier Type: -

Identifier Source: org_study_id

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