Caregiver Burnout
Conditions
Keywords
Assistive Technology, Informal Caregivers, Occupational Therapy, Toileting
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.
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).
Interventions
BEHAVIORALAutomated 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.
OTHERNo Intervention
Waitlist control
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Recruited | 5 months | The ability to recruit 10 caregivers who were eligible for the study was used with other variables to assess feasibility |
| Number of Caregivers Retained | At study completion (2 months [treatment] or 3 months [waitlist control]) | Retain 10 caregivers was used with other variables to assess feasibility |
| Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed | 30 days post-installation | Installation of the automated bidets and a record of any modifications needed was used with other variables to assess feasibility |
| Number of Caregivers' or Care Recipients' Who Can Operate the Bidet | 30 days post-installation | Demonstrate ability to operate the bidet successfully which was used with other variables to assess feasibility |
| Acceptability | 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 |
| Preliminary Efficacy: Performance | 2 months (treatment) or 3 months (waitlist control) | 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 |
| Preliminary Efficacy: Satisfaction | 2 months (treatment) or 3 months (waitlist control) | 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 |
| Preliminary Efficacy: Self-efficacy | 2 months (treatment) or 3 months (waitlist control) | 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 |
| Preliminary Efficacy: Physical Environmental Barriers | 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) was used with other variables to assess feasibility |
| Adverse Events | At study completion (2 months [treatment] or 3 months [waitlist control]) | Number of adverse events was used with other variables to assess feasibility |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Waitlist Control Caregivers will wait for 30 days and then will be offered the intervention.
No Intervention: Waitlist control | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Treatment | Total | Waitlist Control |
|---|---|---|---|
| Age, Continuous | 68.40 years STANDARD_DEVIATION 10.29 | 66.40 years STANDARD_DEVIATION 11.87 | 64.40 years STANDARD_DEVIATION 14.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 8 Participants | 3 Participants |
| Region of Enrollment United States | 5 participants | 10 participants | 5 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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
Time frame: 30 days post-installation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Acceptability | The automated bidet system was aesthetically pleasing/looked nice. | 3.60 units on a scale | Standard Deviation 0.55 |
| Treatment | Acceptability | The automated bidet system was easy to use | 3.60 units on a scale | Standard Deviation 0.55 |
| Treatment | Acceptability | The education and training on using the automated bidet system was very helpful | 4.00 units on a scale | Standard Deviation 0 |
| Treatment | 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 |
| Treatment | Acceptability | I feel more confident assisting my loved one with toileting tasks | 3.20 units on a scale | Standard Deviation 0.84 |
| Treatment | 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 |
| Treatment | 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 |
| Treatment | 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 |
| Waitlist Control | Acceptability | The education and training on using the automated bidet system was very helpful | 4.00 units on a scale | Standard Deviation 0 |
| Waitlist Control | 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 |
| Waitlist Control | 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 |
| Waitlist Control | Acceptability | I feel more confident assisting my loved one with toileting tasks | 3.80 units on a scale | Standard Deviation 0.45 |
| Waitlist Control | Acceptability | The automated bidet addressed my concerns for providing assistance with toileting in the home | 3.60 units on a scale | Standard Deviation 0.55 |
| Waitlist Control | Acceptability | The automated bidet system was aesthetically pleasing/looked nice. | 4.00 units on a scale | Standard Deviation 0 |
| Waitlist Control | Acceptability | The automated bidet system was easy to use | 4.00 units on a scale | Standard Deviation 0 |
| Waitlist Control | Acceptability | The presence of my loved one during study visits impacted my ability to answer questions truthfully | 4.00 units on a scale | Standard Deviation 0 |
| Total | Acceptability | The education and training on using the automated bidet system was very helpful | 4.00 units on a scale | Standard Deviation 0 |
| Total | Acceptability | The automated bidet system was easy to use | 3.80 units on a scale | Standard Deviation 0.42 |
| Total | Acceptability | The automated bidet system was aesthetically pleasing/looked nice. | 3.80 units on a scale | Standard Deviation 0.42 |
| Total | 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 0.42 |
| Total | 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 |
| Total | Acceptability | The automated bidet addressed my concerns for providing assistance with toileting in the home | 3.40 units on a scale | Standard Deviation 0.52 |
| Total | Acceptability | I feel more confident assisting my loved one with toileting tasks | 3.50 units on a scale | Standard Deviation 0.71 |
| Total | Acceptability | The presence of my loved one during study visits impacted my ability to answer questions truthfully | 3.70 units on a scale | Standard Deviation 0.95 |
Primary
Adverse Events
Number of adverse events was used with other variables to assess feasibility
Time frame: At study completion (2 months [treatment] or 3 months [waitlist control])
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Adverse Events | 0 adverse events |
| Waitlist Control | Adverse Events | 0 adverse events |
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
Time frame: 30 days post-installation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Caregivers' or Care Recipients' Who Can Operate the Bidet | 5 Participants |
| Waitlist Control | Number of Caregivers' or Care Recipients' Who Can Operate the Bidet | 5 Participants |
Primary
Number of Caregivers Retained
Retain 10 caregivers was used with other variables to assess feasibility
Time frame: At study completion (2 months [treatment] or 3 months [waitlist control])
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Caregivers Retained | 5 Participants |
| Waitlist Control | Number of Caregivers Retained | 5 Participants |
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
Time frame: 5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Recruited | 5 Participants |
| Waitlist Control | Number of Participants Recruited | 5 Participants |
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
Time frame: 30 days post-installation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed | 5 Participants |
| Waitlist Control | Number of Participants With Ability to Install the Automated Bidets, Including Any Modifications Needed | 5 Participants |
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
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Preliminary Efficacy: Performance | Pretest | 3.20 units on a scale | Standard Deviation 1.3 |
| Treatment | Preliminary Efficacy: Performance | Posttest | 4.20 units on a scale | Standard Deviation 0.45 |
| Waitlist Control | Preliminary Efficacy: Performance | Pretest | 4.20 units on a scale | Standard Deviation 0.84 |
| Waitlist Control | Preliminary Efficacy: Performance | Posttest | 3.40 units on a scale | Standard Deviation 0.89 |
| Waitlist Control | Preliminary Efficacy: Performance | Follow-up | 4.40 units on a scale | Standard Deviation 0.55 |
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
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Preliminary Efficacy: Physical Environmental Barriers | Pretest | 10.20 units on a scale | Standard Deviation 3.7 |
| Treatment | Preliminary Efficacy: Physical Environmental Barriers | Posttest | 8.20 units on a scale | Standard Deviation 3.11 |
| Waitlist Control | Preliminary Efficacy: Physical Environmental Barriers | Posttest | 8.60 units on a scale | Standard Deviation 3.36 |
| Waitlist Control | Preliminary Efficacy: Physical Environmental Barriers | Pretest | 9.00 units on a scale | Standard Deviation 3.39 |
| Waitlist Control | Preliminary Efficacy: Physical Environmental Barriers | Follow-up | 6.40 units on a scale | Standard Deviation 2.7 |
| Total | Preliminary Efficacy: Physical Environmental Barriers | Posttest | 8.40 units on a scale | Standard Deviation 3.06 |
| Total | Preliminary Efficacy: Physical Environmental Barriers | Follow-up | 6.40 units on a scale | Standard Deviation 2.7 |
| Total | Preliminary Efficacy: Physical Environmental Barriers | Pretest | 9.60 units on a scale | Standard Deviation 3.41 |
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
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Preliminary Efficacy: Satisfaction | Pretest | 3.20 units on a scale | Standard Deviation 1.48 |
| Treatment | Preliminary Efficacy: Satisfaction | Posttest | 4.40 units on a scale | Standard Deviation 0.55 |
| Waitlist Control | Preliminary Efficacy: Satisfaction | Pretest | 3.40 units on a scale | Standard Deviation 1.14 |
| Waitlist Control | Preliminary Efficacy: Satisfaction | Posttest | 3.00 units on a scale | Standard Deviation 0.71 |
| Waitlist Control | Preliminary Efficacy: Satisfaction | Follow-up | 4.60 units on a scale | Standard Deviation 0.55 |
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
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Preliminary Efficacy: Self-efficacy | Pretest | 3.20 units on a scale | Standard Deviation 1.3 |
| Treatment | Preliminary Efficacy: Self-efficacy | Posttest | 4.60 units on a scale | Standard Deviation 0.55 |
| Waitlist Control | Preliminary Efficacy: Self-efficacy | Posttest | 3.60 units on a scale | Standard Deviation 0.55 |
| Waitlist Control | Preliminary Efficacy: Self-efficacy | Follow-up | 4.80 units on a scale | Standard Deviation 0.45 |
| Waitlist Control | Preliminary Efficacy: Self-efficacy | Pretest | 3.60 units on a scale | Standard Deviation 1.52 |