Caregiver BurnoutNCT04283123
Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden
A study testing Automated Bidet in people with Caregiver Burnout, run by Washington University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burnout
- What is being tested?
- Automated Bidet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- Caregivers scoring 10 or above on the Short Blessed Test, indicating possible cognitive impairment
About this study
Official title: 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.
Read the 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).
- Conditions
- Caregiver Burnout
- Being tested
- Automated Bidet, No Intervention
- Keywords
- Assistive Technology, Informal Caregivers, Occupational Therapy, Toileting
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated BidetBehavioural
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.
No InterventionOther
Waitlist control
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Behavioral: Automated Bidet |
| Waitlist Control | Active comparator | Caregivers will wait for 30 days and then will be offered the intervention. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Recruited
The ability to recruit 10 caregivers who were eligible for the study was used with other variables to assess feasibility
Measured: 5 months
Number of Caregivers Retained
Retain 10 caregivers was used with other variables to assess feasibility
Measured: At study completion (2 months [treatment] or 3 months [waitlist control])
Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed
Installation of the automated bidets and a record of any modifications needed was used with other variables to assess feasibility
Measured: 30 days post-installation
Number of Caregivers' or Care Recipients' Who Can Operate the Bidet
Demonstrate ability to operate the bidet successfully which was used with other variables to assess feasibility
Measured: 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
Measured: 30 days post-installation
Preliminary Efficacy: Performance
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
Measured: 2 months (treatment) or 3 months (waitlist control)
Preliminary Efficacy: Satisfaction
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
Measured: 2 months (treatment) or 3 months (waitlist control)
Preliminary Efficacy: Self-efficacy
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
Measured: 2 months (treatment) or 3 months (waitlist control)
Preliminary Efficacy: Physical Environmental Barriers
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
Measured: 2 months (treatment) or 3 months (waitlist control)
Adverse Events
Number of adverse events was used with other variables to assess feasibility
Measured: At study completion (2 months [treatment] or 3 months [waitlist control])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Dec 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Stark, Washington University School of Medicine
- Investigators
- Susan Stark, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283123
- Sponsor's protocol ID
- 201610044
- Status last verified
- Aug 2025
- First submitted
- 14 Feb 2020
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden
- ClinicalTrials.gov ID
- NCT04283123
- Acronym / sponsor ID
- 201610044
- Conditions
- Caregiver Burnout
- Keywords
- Assistive Technology, Informal Caregivers, Occupational Therapy, Toileting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Automated BidetParticipants 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. |
| Waitlist Control | Active comparator | Other: No InterventionCaregivers will wait for 30 days and then will be offered the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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
Key exclusion criteria (1 listed)
- Caregivers scoring 10 or above on the Short Blessed Test, indicating possible cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated BidetDuring 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. | Behavioural | Treatment |
| No InterventionWaitlist control | Other | Waitlist Control |
Primary outcome
Number of Participants Recruited
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days post-installation
Demonstrate ability to operate the bidet successfully which was used with other variables to assess feasibility
Acceptability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Adverse Events
Time frame: At study completion (2 months [treatment] or 3 months [waitlist control])
Number of adverse events was used with other variables to assess feasibility
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Stark, PhD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Automated Bidet in people with Caregiver Burnout, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Recruited (time frame: 5 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.