search
Back to results

Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

Primary Purpose

Caregiver Burnout

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Automated Bidet
No Intervention
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caregiver Burnout focused on measuring Assistive Technology, Informal Caregivers, Occupational Therapy, Toileting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment

    Waitlist Control

    Arm Description

    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.

    Caregivers will wait for 30 days and then will be offered the intervention.

    Outcomes

    Primary Outcome Measures

    Number of participants recruited
    Recruit 10 caregivers
    Number of caregivers retained
    Retain 10 caregivers
    Ability to install the automated bidets, including any modifications needed
    Installation of the automated bidets and a record of any modifications needed
    Caregivers' or care recipients' ability to operate the bidet
    Demonstrate ability to operate the bidet successfully
    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
    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)
    Adverse events
    Number of adverse events

    Secondary Outcome Measures

    Full Information

    First Posted
    February 14, 2020
    Last Updated
    February 20, 2020
    Sponsor
    Washington University School of Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04283123
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2016 (Actual)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caregiver Burnout
    Keywords
    Assistive Technology, Informal Caregivers, Occupational Therapy, Toileting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Waitlist Control
    Arm Type
    Active Comparator
    Arm Description
    Caregivers will wait for 30 days and then will be offered the intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Automated Bidet
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    No Intervention
    Intervention Description
    Waitlist control
    Primary Outcome Measure Information:
    Title
    Number of participants recruited
    Description
    Recruit 10 caregivers
    Time Frame
    5 months
    Title
    Number of caregivers retained
    Description
    Retain 10 caregivers
    Time Frame
    At study completion (2 months [treatment] or 3 months [waitlist control])
    Title
    Ability to install the automated bidets, including any modifications needed
    Description
    Installation of the automated bidets and a record of any modifications needed
    Time Frame
    30 days post-installation
    Title
    Caregivers' or care recipients' ability to operate the bidet
    Description
    Demonstrate ability to operate the bidet successfully
    Time Frame
    30 days post-installation
    Title
    Acceptability
    Description
    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
    Time Frame
    30 days post-installation
    Title
    Preliminary efficacy
    Description
    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)
    Time Frame
    2 months (treatment) or 3 months (waitlist control)
    Title
    Adverse events
    Description
    Number of adverse events
    Time Frame
    At study completion (2 months [treatment] or 3 months [waitlist control])

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susan Stark, PhD
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

    We'll reach out to this number within 24 hrs