Clinical trial NCT04283123: Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden
Official title: Evaluating the Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burnout
Keywords: Assistive Technology
Informal Caregivers
Occupational Therapy
Toileting
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Recruited
timeFrame: 5 months
measure: Number of Caregivers Retained
timeFrame: At study completion (2 months [treatment] or 3 months [waitlist control])
measure: Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed
timeFrame: 30 days post-installation
measure: Number of Caregivers' or Care Recipients' Who Can Operate the Bidet
timeFrame: 30 days post-installation
measure: Acceptability
timeFrame: 30 days post-installation
measure: Preliminary Efficacy: Performance
timeFrame: 2 months (treatment) or 3 months (waitlist control)
measure: Preliminary Efficacy: Satisfaction
timeFrame: 2 months (treatment) or 3 months (waitlist control)
measure: Preliminary Efficacy: Self-efficacy
timeFrame: 2 months (treatment) or 3 months (waitlist control)
measure: Preliminary Efficacy: Physical Environmental Barriers
timeFrame: 2 months (treatment) or 3 months (waitlist control)
measure: Adverse Events
timeFrame: At study completion (2 months [treatment] or 3 months [waitlist control])
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Susan Stark, PhD
role: PRINCIPAL_INVESTIGATOR
References: