Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden
NCT ID: NCT04283123
Last Updated: 2025-08-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2016-12-01
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Telephone-Based Support for Caregivers of Patients With Dementia
NCT00052104
Improving Hospital-to-Home Care Transitions for High-risk Younger Adult Patients
NCT02532296
Short Message System (SMS) for Caregivers of Suicidal Patients to Prevent Recidivism of Suicide Attempts
NCT03069560
Social Support and Stress Reduction for Caregivers of Young Adults With IDD
NCT05938998
Self-Management Behaviors of Caregivers of the Chronically Critically Ill
NCT03065829
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
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.
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.
Waitlist Control
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention
Waitlist control
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
No Intervention
Waitlist control
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* (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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Susan Stark
Associate Professor of Occupational Therapy, Neurology and Social Work
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susan Stark, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201610044
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.