Evaluating the Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden
Phase: NA
Conditions: Caregiver Burnout
Sponsor: Washington University School of Medicine

February 2020 
 
 
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Evaluating the Feasibility of an Automated Bidet 
Intervention to Decrease Caregiver Burden 
(NCT04283123) 
 
Study Protocol 
 
 
 

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Table of Contents 
WORLD HEALTH ORGANIZATION DATA SET ..................................................................3 
ORGANIZATIONAL STRUCTURE AND RESPONSIBILITIES ..........................................5 
STUDY OBJECTIVES ..................................................................................................................5 
BACKGROUND & STUDY RATIONALE ................................................................................5 
STUDY DESIGN ............................................................................................................................6 
PARTICIPANTS............................................................................................................................6 
INFORMED CONSENT ...............................................................................................................7 
STUDY INTERVENTION ............................................................................................................7 
RANDOMIZATION ......................................................................................................................8 
DATA COLLECTION ..................................................................................................................8 
STATISTICAL ANALYSES ........................................................................................................9 
POTENTIAL BENEFITS, RISKS, AND ALTERNATIVES ....................................................9 
MINIMIZATION OF RISKS AND CONFIDENTIALITY ......................................................9 
ADVERSE EVENT REPORTING AND SAFETY MONITORING .......................................9 
PREMATURE STUDY TERMINATION .................................................................................10 
INDEMNITY ................................................................................................................................10 
ETHICS AND DISSEMINATION .............................................................................................10 
REFERENCES .............................................................................................................................10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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World Health Organization Data Set 
Primary Registry 
and Trial 
Identifying Number 
ClinicalTrials.gov: NCT04283123 
Date of 
Registration  
February 14, 2020 
Secondary 
Identifying 
Numbers 
IRB ID#: 201610044 
Source(s) of 
Monetary Support 
TOTO USA, Inc 
 
Primary Sponsor 
Washington University School of Medicine 
Secondary 
Sponsor(s) 
 
N/A 
Contact for Public 
Queries 
Susan Stark, PhD, OTR/L 
sstark@wustl.edu 
314-273-4114 
Program in Occupational Therapy 
Washington University School of Medicine 
5232 Oakland Ave 
St. Louis, MO 63110 
United States  
 
Contact for 
Scientific Queries 
Susan Stark, PhD, OTR/L 
sstark@wustl.edu 
314-273-4114 
Program in Occupational Therapy 
Washington University School of Medicine 
5232 Oakland Ave 
St. Louis, MO 63110 
United States  
 
Public Title 
Feasibility of an Automated Bidet Intervention to Decrease Caregiver 
Burden 
 
Scientific Title 
 
Evaluating the Feasibility of an Automated Bidet Intervention to Decrease 
Caregiver Burden   
Countries of 
Recruitment 
United States 
Health Condition(s) 
or Problem(s) 
Caregiver Burnout   

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Intervention(s) 
 
Study arm 1: 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. 
• 
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. 
Study arm 2: Waitlist Control 
• 
Caregivers will wait for 30 days and then will be offered the 
intervention. 
• 
No intervention. 
 
Key Inclusion and 
Exclusion 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:  
(1) Caregivers scoring 10 or above on the Short Blessed Test, indicating 
possible cognitive impairment 
 
Study Type 
 
Randomized waitlist control feasibility study 
 
Date of First 
Enrollment 
December 20, 2016 
Target Sample Size 
10 
Recruitment Status 
Complete  
Primary 
Outcome(s) 
 
1. Number of participants recruited  
2. Number of caregivers retained  
3. Ability to install the automated bidets, including any modifications needed  
4. Caregivers’ or care recipients’ ability to operate the bidet  
5. Acceptability 
6. Preliminary efficacy: reduction of physical barriers to toileting 
7. Preliminary efficacy: Performance 
8. Preliminary efficacy: Satisfaction 
9. Preliminary efficacy: Self-efficacy  
10. Adverse events 
 

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Organizational Structure and Responsibilities 
Susan Stark, Ph.D., OTR/L FAOTA is the principal investigator and will manage and oversee 
all aspects of this project. She will ensure compliance with quality-assurance requirements as 
stipulated by human subjects, and submit appropriate materials as needed throughout the 
study.  
 
Rebecca Bollinger, OTD/S will coordinate this study by developing study materials, reporting 
adverse and serious events for all participants, recruiting, screening, and enrolling participants, 
as well as implementing quality control procedures, and assisting in data management and 
analysis. She will also develop materials for regulating bodies with assistance from study staff.  
 
Emily Somerville, MS, OTR/L will supervise and train staff during this study.  
   
Marian Keglovits, OTD, MSCI, OTR/L will train staff and assist with assessments and 
statistical analysis performed for this project.  
 
Yi-Ling Hu, MS will assist with data analysis for this study and maintain randomization codes. 
Study Objectives 
The objective of this feasibility study is 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. 
Background & Study Rationale  
Informal caregivers are unpaid family members or friends that provide over 30 billion hours of 
care annually for older adults (Chari, Engberg, Ray, & Mehrotra, 2015). They assist with 
activities of daily living (ADLs) and instrumental activities of daily living (IADLs), enabling their 
loved one to remain at home (Darragh et al., 2015; National Alliance for Caregiving and AARP 
Public Policy Institute, 2015). However, they often receive little to no training, especially for 
assisting with toileting, and are at an increased risk for physical injury, stress, and burnout 
(Darragh et al., 2015; National Alliance for Caregiving and AARP Public Policy Institute, 2015). 
This jeopardizes their loved ones’ ability to age in place. Care recipients are more likely to be 
placed in a nursing home if they have difficulties completing ADLs such as toileting (Luppa et 
al., 2010). 
 
 
Informal caregivers report that assisting with toileting and managing incontinence are some of 
the most difficult ADLs (Darragh et al., 2015; King, Holliday, & Andrews, 2018; National Alliance 
for Caregiving and AARP Public Policy Institute, 2015). Informal caregivers with low self-efficacy 
or beliefs about their ability to assist with toileting tasks are at risk of experiencing depression or 
burnout (Bandura, 1982; Gilliam & Steffen, 2006; Grano, Lucidi, & Violani, 2017). Thus, a 
potential solution is an automated bidet system, a toilet seat with built-in cleaning features, to 
replace physical support provided by a caregiver for toileting. Automated bidet systems have 
been shown to reduce caregivers’ use of non-neutral postures by 15% and severe trunk flexion 
by 32% (King et al., 2019). In another study, participants reported an increase in competence, 
adaptability, and self-esteem after using an automated bidet system compared to their regular 
toileting routine (Yachnin, Gharib, Jutai, & Finestone, 2017). Automated bidet systems have the 
potential to increase caregivers’ self-efficacy, increase caregivers’ satisfaction, reduce the 
amount of physical assistance needed for toileting, and decrease caregivers’ risk for injury when 
assisting with toileting.  

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Study Design  
In this randomized waitlist control feasibility study, ten informal caregivers and care recipient 
dyads will be recruited to the study and randomly assigned to either the treatment group or the 
waitlist control group. The treatment group will participate in the intervention immediately, 
receiving the automated bidet system and training, while the control group waits to receive the 
automated bidet. After completion of this phase, control participants will be provided with the 
automated bidet system and subsequent training. Outcome measures will be collected at 
pretest and posttest (30 days post-intervention for the treatment group or 30 days post-
enrollment for the control group), and at follow-up for the waitlist control group (30 days post-
installation). Assessments will be used to evaluate the feasibility of the feasibility, acceptability, 
and preliminary efficacy of this OT intervention to reduce the amount of assistance needed from 
caregivers. Overview of the study’s major steps is shown in Figure 1.  
Figure 1: Study Flow Diagram 
 
Participants 
Ten informal caregivers will be recruited to participate in this study from a study registry, 
clinicians, exercise groups, and word of mouth in St. Louis, Missouri. 
 
Informal caregivers will be contacted by phone and screened for eligibility. Caregivers will be 
eligible for this study if they: (1) provide unpaid care and lived with a care recipient aged 55 

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years or older; (2) have assisted with toileting for at least 6 months; (3) do not have an 
automated bidet; (4) have a working toilet and bathroom outlet; and (5) their care recipient is 
willing to participate. Participants will be excluded if they score a 10 or above on the Short 
Blessed Test, indicating a possible cognitive impairment.  
Informed Consent  
Written informed consent to participate in the study will be obtained before any assessments are 
conducted. If eligible, an occupational therapist (OT) will schedule a time to obtain consent at 
the potential participant’s home. All elements of consent will be reviewed with caregivers prior to 
enrolling in the study, including the purpose of the study, risks, benefits, alternatives to the 
study, how confidentiality will be maintained, the PI’s contact information, no consequences to 
withdrawal, and how study results will be shared. Participants will be given a copy of the signed 
consent for their records.  
 
A written waiver of consent/exempt information sheet will be presented in person to all care 
recipients at the initial interview prior to administering the IHOPE-Assist. The OT will review the 
exempt information sheet with the care recipient during the consent visit in a private setting, 
including the purpose of the study, study procedures, and how confidentiality will be maintained. 
If the care recipient does not want to participate in the performance-based component of the 
evaluation, which includes toileting activities normally done in the home with the assistance of a 
caregiver, then the caregiver and care recipient will not be enrolled in the research study.  
 
All study staff have undergone IRB training. In addition, all staff members have participated in 
cultural competence training and are trained to interview older adults. All study documents will 
be available in multiple formats, are developed in 12-point Arial font, and are written in plain 
language. If a participant needs to be re-consented at any point during the study, the study staff 
will visit the person in home and repeat the consent process. All signed consents will be stored 
in the office of the PI under double locks.  
Study Intervention  
After randomization, the OT will contact all participants to inform them of their group allocation 
(Treatment or Control). A home visit will be scheduled as soon as possible for the participants in 
the treatment group. The waitlist control group will wait 30 days before receiving the automated 
bidet system and subsequent training.  
 
Intervention Procedures. A visit will be scheduled after the pretest visit for installation and 
training on the automated bidet system (TOTO Washlet S300e with remote control). During the 
first intervention visit, the licensed contractor will install the automated bidet. After installation, 
the OT will provide training to the caregiver and care recipient on using the automated bidet 
system and will make modifications to the remote as needed. A second intervention visit will be 
completed 1-2 weeks post-installation to address any new difficulties with using the automated 
bidet system. During the intervention visits, the OT will utilize motivational enhancement and 
active practice, and provide education on programming the remote control for the care 
recipient’s desired temperature, water pressure, and wand position to increase independence 
with toilet hygiene. The caregiver will be instructed to contact the OT if they have any questions. 
 
Control Group Procedures. The procedures for the waitlist control group will be the same as 
above. During the initial 30 days, participants randomized to the control group will wait to 
receive the automated bidet. After completing assessments after the first 30 days, they will 
receive the automated bidet and follow the same intervention procedures described above.   

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Randomization  
Caregivers will be randomized using a 1:1 ratio by gender with a web-based randomization tool, 
Research Electronic Data Capture system (REDCap) after signing the consent (Harris et al., 
2009). Randomization sequence concealment will be achieved by the Research Electronic Data 
Capture (REDCap) system (Harris et al., 2009).     
Data Collection 
Data will be collected at pretest and posttest (30 days post-intervention for the treatment group 
or 30 days post-enrollment for the control group), for the caregiver and care recipient in the 
participants’ homes. Caregivers in the waitlist control group will also complete assessments at 
follow-up (30 days post-installation). 
Covariate Assessments to be collected during the initial screening from the caregiver: 
Demographics. Caregivers will be asked basic demographic information that includes birthdate, 
gender, marital status, ethnicity, income, years of education, years of caregiving, relation to care 
recipient, diagnosis of care recipient, and hours of caregiving provided per week. 
Short Blessed Test (SBT). The SBT is a six-item measure that will be used to assess the 
caregiver’s cognition, memory, and orientation as a screening tool prior to enrolling in the study 
(Katzman et al., 1983). The SBT has good validity. The score for each item is calculated based 
on the number of errors and a weighting factor; these scores are combined to calculate the total 
score. Total scores range from 0-28; higher scores indicate more cognitive impairment. Informal 
caregivers who score 10 or above will not be eligible for the study as that indicates impairments 
consistent with dementia. 
Primary endpoint assessments to be completed by the caregiver throughout the study: 
In-Home Occupational Performance Evaluation for Providing Assistance (I-HOPE Assist). The I-
HOPE Assist is a reliable and valid assessment which measures caregivers’ self-reported 
satisfaction and performance, impact of environmental barriers, and self-efficacy for assistance 
with 43 specific daily activities (Keglovits, Somerville, & Stark, 2015). Caregivers use activity 
cards to identify the top 10 caregiving activities which are difficult or worrisome for them, one of 
which must be toileting. Next, they provide self-ratings of their performance, satisfaction with 
performance and self-efficacy for those activities on a scale of 0 to 5, with higher scores 
indicating better performance, satisfaction, and self-efficacy. For self-care and transfers for 
toileting, the OT will also record barriers to performance and rate the impact of the barrier on the 
caregiver’s performance, yielding scores of barrier severity. This assessment will be used to 
measure changes in caregiver performance, satisfaction, and self-efficacy for providing 
assistance with toileting to evaluate the effects of the automated bidet system intervention on 
caregiver outcomes.  
Process Evaluation. During the final study visit, caregivers will complete an 8-item process 
evaluation to assess the feasibility of the toileting intervention using an automated bidet system. 
Caregivers will rate how much they thought the automated bidet: (1) made assisting with 
toileting easier, (2) improved their confidence, and (3) addressed their concerns for assisting the 
care recipient with toileting. Caregivers will rate agreement with statements about the 
appearance, ease of use, and training and whether they will continue to use the automated 
bidet after the study on a scale of 0 (strongly disagree) to 4 (strongly agree), with higher scores 
indicating greater acceptance of the intervention. Caregivers will also complete a qualitative 

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interview to determine whether the number and length of visits were sufficient.  
Statistical Analyses 
Descriptive statistics will be used to examine demographic characteristics and feasibility 
outcomes. A Wilcoxon-signed rank test will be used to examine secondary outcomes to 
compare groups. Qualitative interviews will be analyzed using a grounded theory approach and 
constant comparative analysis. 
Potential Benefits, Risks, and Alternatives 
Benefits. Participants may or may not benefit from being in this study. The information from this 
study may help researchers to better understand and address the needs of caregivers in the 
future.       
 
Risks. Visits may result in feeling tired or disrupted. In addition, some questions, or 
demonstrations performing activities caregivers assist with, may touch on emotionally sensitive 
issues that could cause anxiety, embarrassment, or other forms of emotional stress. 
Participants will be told that their involvement in this research study is voluntary and that they 
may choose not to participate or to withdraw their consent at any time. Participants who 
undergo the study visits will be given the option to take a break or reschedule the visit at any 
time. All research-related information will be kept confidential and accessible only to authorized 
members of the research team. 
Minimization of Risks and Confidentiality 
To protect against and minimize potential risks, participants will be carefully screened and 
evaluated for eligibility by the research coordinator. To avoid or minimize symptoms of fatigue or 
emotional distress during visits, participants will be instructed to notify the rater or interventionist 
if they experience any discomfort. They will also be periodically questioned about their tolerance 
for the tests/intervention. Testing and interviews will be terminated if participants develop fatigue 
or emotional distress.  
 
To help protect participants’ confidentiality, an ID number will be assigned to each participant. 
All data collected from a participant will be labeled with that ID number. All participant electronic 
and hard-copy data will be kept under double-lock protection. All hard-copy forms that contain 
personal identifiers (e.g., name, address, phone number) will be stored in a separate, locked file 
drawer under double-lock protection. No publication or presentation of the study data will 
uniquely identify or provide sufficient information to uniquely identify participants. 
 
To guard against unauthorized data access, all shared-use computer systems at Washington 
University School of Medicine are protected with passwords, which are changed at 4-month 
intervals. Only individuals with a particular "need to know" status are given access, and system 
privileges are carefully restricted. All personal computers to be used in the Administrative Unit 
are located within a secure area, and the system is locked when not in use. SAS and SPSS 
software packages will be used for data management and analysis. Datasets generated from 
these programs will be password protected, which will make accessing study data difficult even 
in the event that unauthorized computer access occurs.  
Adverse Event Reporting and Safety Monitoring 
All SAEs will be reported to the Human Research Protection Office in the following time frames: 
(a) death–immediately, (b) life-threatening–within 7 calendar days, (c) all other SAEs–within 15 

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calendar days using the Electronic Serious Adverse Event Reporting System. Should an SAE 
occur that increases the risk to the participants, the study will be stopped, an investigation will 
be conducted, and a findings report will be generated before the study is resumed. 
 
Dr. Stark will be responsible for reviewing study progress and outcomes including recruitment, 
data quality, safety, and efficacy. Quarterly reports will be reviewed by the principal investigator. 
Because risk in the proposed study is considered minimal, the data monitoring plan will include 
continuous, close monitoring by the study investigator with prompt reporting of any AEs. Ms. 
Bollinger will monitor the study for AEs, adherence to the protocol, and safety. 
Premature Study Termination 
Preliminary study data will be monitored by the data management team for any potentially 
harmful outcomes. If interim data raise significant safety concerns, the trial will be ended early.  
Indemnity 
Washington University School of Medicine is responsible for any non-negligent damage incurred 
as a result of participating in this study. The indemnity is renewed on an annual basis. 
Washington University School of Medicine assures that it will continue renewal of the indemnity 
for the duration of the trial.  
Ethics and Dissemination 
The informed consent forms will be reviewed and approved by the Washington University IRB 
with respect to scientific content and compliance with applicable research and human subjects 
regulations. All study personnel involved in the conduct of this research will receive the required 
education on the protection of human participant rights.  
References 
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122-147. doi:10.1037/0003-066x.37.2.122 
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elder-care in the United States: New estimates from the american time use survey. 
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(2015). Musculoskeletal discomfort, physical demand, and caregiving activities in 
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