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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Waitlist Control | Active Comparator | Caregivers will wait for 30 days and then will be offered the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated Bidet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Recruited | The ability to recruit 10 caregivers who were eligible for the study was used with other variables to assess feasibility | 5 months |
| Number of Caregivers Retained | Retain 10 caregivers was used with other variables to assess feasibility | At study completion (2 months [treatment] or 3 months [waitlist control]) |
| Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed | Installation of the automated bidets and a record of any modifications needed was used with other variables to assess feasibility | 30 days post-installation |
| Number of Caregivers' or Care Recipients' Who Can Operate the Bidet | Demonstrate ability to operate the bidet successfully which was used with other variables to assess feasibility | 30 days post-installation |
| 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 | 30 days post-installation |
| Preliminary Efficacy: Performance | 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 | 2 months (treatment) or 3 months (waitlist control) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Stark, PhD | Washington University School of Medicine | Principal Investigator |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Waitlist Control | Caregivers will wait for 30 days and then will be offered the intervention. No Intervention: Waitlist control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Recruited | The ability to recruit 10 caregivers who were eligible for the study was used with other variables to assess feasibility | Posted | Count of Participants | Participants | 5 months |
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Baseline to study completion (2 months [treatment] or 3 months [waitlist control])
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Stark, PhD, OTR/L, FAOTA | Washington University School of Medicine in St. Louis | (314)273-4114 | sstark@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2020 | Nov 21, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| No Intervention | Other | Waitlist control |
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| Preliminary Efficacy: Satisfaction |
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 |
| 2 months (treatment) or 3 months (waitlist control) |
| Preliminary Efficacy: Self-efficacy | 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 | 2 months (treatment) or 3 months (waitlist control) |
| Preliminary Efficacy: Physical Environmental Barriers | 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 | 2 months (treatment) or 3 months (waitlist control) |
| Adverse Events | Number of adverse events was used with other variables to assess feasibility | At study completion (2 months [treatment] or 3 months [waitlist control]) |
| BG001 | Waitlist Control | Caregivers will wait for 30 days and then will be offered the intervention. No Intervention: Waitlist control |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Waitlist Control | Caregivers will wait for 30 days and then will be offered the intervention. No Intervention: Waitlist control |
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| Primary | Number of Caregivers Retained | Retain 10 caregivers was used with other variables to assess feasibility | Posted | Count of Participants | Participants | At study completion (2 months [treatment] or 3 months [waitlist control]) |
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| Primary | Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed | Installation of the automated bidets and a record of any modifications needed was used with other variables to assess feasibility | Posted | Count of Participants | Participants | 30 days post-installation |
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| Primary | Number of Caregivers' or Care Recipients' Who Can Operate the Bidet | Demonstrate ability to operate the bidet successfully which was used with other variables to assess feasibility | Posted | Count of Participants | Participants | 30 days post-installation |
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| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | 30 days post-installation |
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| Primary | Preliminary Efficacy: Performance | 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | 2 months (treatment) or 3 months (waitlist control) |
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|
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| Primary | Preliminary Efficacy: Satisfaction | 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | 2 months (treatment) or 3 months (waitlist control) |
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|
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| Primary | Preliminary Efficacy: Self-efficacy | 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | 2 months (treatment) or 3 months (waitlist control) |
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| Primary | Preliminary Efficacy: Physical Environmental Barriers | 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | 2 months (treatment) or 3 months (waitlist control) |
|
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| Primary | Adverse Events | Number of adverse events was used with other variables to assess feasibility | Posted | Number | adverse events | At study completion (2 months [treatment] or 3 months [waitlist control]) |
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Waitlist Control | Caregivers will wait for 30 days and then will be offered the intervention. No Intervention: Waitlist control | 0 | 5 | 0 | 5 | 0 | 5 |
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| The education and training on using the automated bidet system was very helpful |
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| The automated bidet system made it easier for me to help my loved one with toileting |
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| I feel more confident assisting my loved one with toileting tasks |
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| The automated bidet addressed my concerns for providing assistance with toileting in the home |
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| We will continue to use the automated bidet system after the conclusion of the study |
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| The presence of my loved one during study visits impacted my ability to answer questions truthfully |
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| Posttest |
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| Follow-up |
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| Cohen's d |
| 0.45 |
| 2-Sided |
Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria. |
| Other |
Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria. |
| Posttest |
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| Follow-up |
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| Cohen's d |
| 0.32 |
| 2-Sided |
Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria. |
| Other |
Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria. |
| Posttest |
|
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| Follow-up |
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| Cohen's d |
| 0.12 |
| 2-Sided |
Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria. |
| Other |
Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria. |
| Posttest |
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| Follow-up |
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