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Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283123
Recruitment Status : Completed
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Susan Stark, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Caregiver Burnout Behavioral: Automated Bidet Other: No Intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Treatment
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.
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.

Active Comparator: Waitlist Control
Caregivers will wait for 30 days and then will be offered the intervention.
Other: No Intervention
Waitlist control




Primary Outcome Measures :
  1. Number of participants recruited [ Time Frame: 5 months ]
    Recruit 10 caregivers

  2. Number of caregivers retained [ Time Frame: At study completion (2 months [treatment] or 3 months [waitlist control]) ]
    Retain 10 caregivers

  3. 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

  4. Caregivers' or care recipients' ability to operate the bidet [ Time Frame: 30 days post-installation ]
    Demonstrate ability to operate the bidet successfully

  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 [ 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)], and impact on caregiver outcomes (rated on a scale of 1 to 5 with higher scores indicating better performance, satisfaction, and self-efficacy)

  7. Adverse events [ Time Frame: At study completion (2 months [treatment] or 3 months [waitlist control]) ]
    Number of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283123


Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Susan Stark, PhD Washington University School of Medicine
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Responsible Party: Susan Stark, Associate Professor of Occupational Therapy, Neurology and Social Work, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04283123    
Other Study ID Numbers: 201610044
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Stark, Washington University School of Medicine:
Assistive Technology
Informal Caregivers
Occupational Therapy
Toileting
Additional relevant MeSH terms:
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Burnout, Psychological
Stress, Psychological
Behavioral Symptoms