Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

Caregiver Burnout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04283123
• Other study ID #: 201610044
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: February 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Psychological
• Caregiver Burnout

Intervention

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.

Other:
• No Intervention
Waitlist control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited	Recruit 10 caregivers	5 months
Primary	Number of caregivers retained	Retain 10 caregivers	At study completion (2 months [treatment] or 3 months [waitlist control])
Primary	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
Primary	Caregivers' or care recipients' ability to operate the bidet	Demonstrate ability to operate the bidet successfully	30 days post-installation
Primary	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
Primary	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)
Primary	Adverse events	Number of adverse events	At study completion (2 months [treatment] or 3 months [waitlist control])