Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

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: Caregiver Burnout
• Intervention / Treatment: Behavioral: Automated Bidet; Other: No Intervention

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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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.	Behavioral: 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.
Active Comparator: Waitlist Control; Caregivers will wait for 30 days and then will be offered the intervention.	Other: No Intervention; Waitlist control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants recruited	Recruit 10 caregivers	5 months
Number of caregivers retained	Retain 10 caregivers	At study completion (2 months [treatment] or 3 months [waitlist control])
Ability to install the automated bidets, including any modifications needed	Installation of the automated bidets and a record of any modifications needed	30 days post-installation
Caregivers' or care recipients' ability to operate the bidet	Demonstrate ability to operate the bidet successfully	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	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)], and impact on caregiver outcomes (rated on a scale of 1 to 5 with higher scores indicating better performance, satisfaction, and self-efficacy)	2 months (treatment) or 3 months (waitlist control)
Adverse events	Number of adverse events	At study completion (2 months [treatment] or 3 months [waitlist control])

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

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 (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Occupational Therapy; Assistive Technology; Informal Caregivers; Toileting
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 201610044

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