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Completed

NCT Number: NCT04283123

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated Bidet

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.

No intervention

Other

Waitlist control

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2020
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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