Trial Outcomes & Findings for Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden (NCT NCT04283123)
NCT ID: NCT04283123
Last Updated: 2025-08-27
Results Overview
The ability to recruit 10 caregivers who were eligible for the study was used with other variables to assess feasibility
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
5 months
Results posted on
2025-08-27
Participant Flow
We contacted 55 informal caregivers from December 2016 to April 2017. Twenty-four(43.6%) expressed interest in participating, but 14 were ineligible (7 did not provide toileting assistance; 3 primarily used a commode or absorbent underwear; 2 had paid caregivers; 1did not meet the age criterion; and 1 care recipient was interested, but the caregiver was not). Ten informal caregivers were enrolled in this study.
Participant milestones
| Measure |
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.
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
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden
Baseline characteristics by cohort
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.40 years
STANDARD_DEVIATION 10.29 • n=93 Participants
|
64.40 years
STANDARD_DEVIATION 14.19 • n=4 Participants
|
66.40 years
STANDARD_DEVIATION 11.87 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 5 monthsThe ability to recruit 10 caregivers who were eligible for the study was used with other variables to assess feasibility
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
All participants combined
|
|---|---|---|---|
|
Number of Participants Recruited
|
5 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: At study completion (2 months [treatment] or 3 months [waitlist control])Retain 10 caregivers was used with other variables to assess feasibility
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
All participants combined
|
|---|---|---|---|
|
Number of Caregivers Retained
|
5 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 days post-installationInstallation of the automated bidets and a record of any modifications needed was used with other variables to assess feasibility
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
All participants combined
|
|---|---|---|---|
|
Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed
|
5 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 days post-installationDemonstrate ability to operate the bidet successfully which was used with other variables to assess feasibility
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
All participants combined
|
|---|---|---|---|
|
Number of Caregivers' or Care Recipients' Who Can Operate the Bidet
|
5 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: 30 days post-installation8-item process evaluation: rated on a scale of 0 (strongly disagree) to 4 (strongly agree) with higher scores indicating greater acceptance of the intervention
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
n=10 Participants
All participants combined
|
|---|---|---|---|
|
Acceptability
The presence of my loved one during study visits impacted my ability to answer questions truthfully
|
3.40 units on a scale
Standard Deviation 1.34
|
4.00 units on a scale
Standard Deviation 0.00
|
3.70 units on a scale
Standard Deviation 0.95
|
|
Acceptability
The automated bidet system was aesthetically pleasing/looked nice.
|
3.60 units on a scale
Standard Deviation 0.55
|
4.00 units on a scale
Standard Deviation 0.00
|
3.80 units on a scale
Standard Deviation 0.42
|
|
Acceptability
The automated bidet system was easy to use
|
3.60 units on a scale
Standard Deviation 0.55
|
4.00 units on a scale
Standard Deviation 0.00
|
3.80 units on a scale
Standard Deviation 0.42
|
|
Acceptability
The education and training on using the automated bidet system was very helpful
|
4.00 units on a scale
Standard Deviation 0.00
|
4.00 units on a scale
Standard Deviation 0.00
|
4.00 units on a scale
Standard Deviation 0.00
|
|
Acceptability
The automated bidet system made it easier for me to help my loved one with toileting
|
3.80 units on a scale
Standard Deviation 0.45
|
3.80 units on a scale
Standard Deviation 0.45
|
3.80 units on a scale
Standard Deviation 0.42
|
|
Acceptability
I feel more confident assisting my loved one with toileting tasks
|
3.20 units on a scale
Standard Deviation 0.84
|
3.80 units on a scale
Standard Deviation 0.45
|
3.50 units on a scale
Standard Deviation 0.71
|
|
Acceptability
The automated bidet addressed my concerns for providing assistance with toileting in the home
|
3.20 units on a scale
Standard Deviation 0.45
|
3.60 units on a scale
Standard Deviation 0.55
|
3.40 units on a scale
Standard Deviation 0.52
|
|
Acceptability
We will continue to use the automated bidet system after the conclusion of the study
|
4.00 units on a scale
Standard Deviation 0.00
|
4.00 units on a scale
Standard Deviation 0.00
|
4.00 units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 2 months (treatment) or 3 months (waitlist control)Population: The I-HOPE Assist was completed with caregivers 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).
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
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
All participants combined
|
|---|---|---|---|
|
Preliminary Efficacy: Performance
Pretest
|
3.20 units on a scale
Standard Deviation 1.30
|
4.20 units on a scale
Standard Deviation 0.84
|
—
|
|
Preliminary Efficacy: Performance
Posttest
|
4.20 units on a scale
Standard Deviation 0.45
|
3.40 units on a scale
Standard Deviation 0.89
|
—
|
|
Preliminary Efficacy: Performance
Follow-up
|
—
|
4.40 units on a scale
Standard Deviation 0.55
|
—
|
PRIMARY outcome
Timeframe: 2 months (treatment) or 3 months (waitlist control)Population: The I-HOPE Assist was completed with caregivers 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).
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
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
All participants combined
|
|---|---|---|---|
|
Preliminary Efficacy: Satisfaction
Pretest
|
3.20 units on a scale
Standard Deviation 1.48
|
3.40 units on a scale
Standard Deviation 1.14
|
—
|
|
Preliminary Efficacy: Satisfaction
Posttest
|
4.40 units on a scale
Standard Deviation 0.55
|
3.00 units on a scale
Standard Deviation 0.71
|
—
|
|
Preliminary Efficacy: Satisfaction
Follow-up
|
—
|
4.60 units on a scale
Standard Deviation 0.55
|
—
|
PRIMARY outcome
Timeframe: 2 months (treatment) or 3 months (waitlist control)Population: The I-HOPE Assist was completed with caregivers 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).
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
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
All participants combined
|
|---|---|---|---|
|
Preliminary Efficacy: Self-efficacy
Posttest
|
4.60 units on a scale
Standard Deviation 0.55
|
3.60 units on a scale
Standard Deviation 0.55
|
—
|
|
Preliminary Efficacy: Self-efficacy
Pretest
|
3.20 units on a scale
Standard Deviation 1.30
|
3.60 units on a scale
Standard Deviation 1.52
|
—
|
|
Preliminary Efficacy: Self-efficacy
Follow-up
|
—
|
4.80 units on a scale
Standard Deviation 0.45
|
—
|
PRIMARY outcome
Timeframe: 2 months (treatment) or 3 months (waitlist control)Population: The I-HOPE Assist was completed with caregivers 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).
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
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
n=10 Participants
All participants combined
|
|---|---|---|---|
|
Preliminary Efficacy: Physical Environmental Barriers
Pretest
|
10.20 units on a scale
Standard Deviation 3.70
|
9.00 units on a scale
Standard Deviation 3.39
|
9.60 units on a scale
Standard Deviation 3.41
|
|
Preliminary Efficacy: Physical Environmental Barriers
Posttest
|
8.20 units on a scale
Standard Deviation 3.11
|
8.60 units on a scale
Standard Deviation 3.36
|
8.40 units on a scale
Standard Deviation 3.06
|
|
Preliminary Efficacy: Physical Environmental Barriers
Follow-up
|
—
|
6.40 units on a scale
Standard Deviation 2.70
|
6.40 units on a scale
Standard Deviation 2.70
|
PRIMARY outcome
Timeframe: At study completion (2 months [treatment] or 3 months [waitlist control])Number of adverse events was used with other variables to assess feasibility
Outcome measures
| Measure |
Treatment
n=5 Participants
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.
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
n=5 Participants
Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control
|
Total
All participants combined
|
|---|---|---|---|
|
Adverse Events
|
0 adverse events
|
0 adverse events
|
—
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susan Stark, PhD, OTR/L, FAOTA
Washington University School of Medicine in St. Louis
Phone: (314)273-4114
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place