Urinary System Disorder
Conditions
Brief summary
This clinical trial tests how well the Bag Below Bladder (B3) Buddy device works in securing urinary drainage bags while walking. Keeping a urinary drainage bag below the bladder is the standard of care to maintain urine flow and prevent urine from backing up into the bladder. Despite the use of modern urinary drainage bags for over 60 years, workarounds, including hooking the bag into pants pockets, are being used to secure the bags while walking. The B3 Buddy may help keep the urinary drainage bag at the proper level for drainage while walking.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the acceptability of the B3 Buddy, from the patient's perspective. II. To evaluate the usability of the B3 Buddy, from the clinician's perspective. OUTLINE: Patients are assigned to 1 of 2 groups. PATIENTS: Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study. CLINICIANS: Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.
Interventions
OTHERAssistance
Assist patient with walking approximately 90 feet
OTHEREducational Intervention
Receive a short instructional session
DEVICEMedical Device Usage and Evaluation
Wear the B3 Buddy device
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURERemove
Remove the device and return urinary drainage bag to the standard position
OTHERWalking
Walk approximately 90 feet
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* PATIENT PARTICIPANT: Must be English-speaking * PATIENT PARTICIPANT: Able to comprehend and agree to consent * PATIENT PARTICIPANT: Able to read and complete the Acceptability of Implementation Measure (AIM) survey * PATIENT PARTICIPANT: Be willing to participate using the B3 Buddy device * PATIENT PARTICIPANT: Have an indwelling urinary catheter or urostomy device connected to a drainage bag * PATIENT PARTICIPANT: Have no restrictions in ambulation * CLINICIAN PARTICIPANT: Must be English-speaking * CLINICIAN PARTICIPANT: Able to comprehend and agree to consent * CLINICIAN PARTICIPANT: Able to read and complete the System Usability Scale (SUS) survey * CLINICIAN PARTICIPANT: Be willing to participate using the B3 Buddy device * CLINICIAN PARTICIPANT: Have a professional role in assisting patients in ambulation in normal workday activities
Exclusion criteria
* Those patient participants that have more than one urinary-like drainage bags will be excluded. This exclusion is due to the limited prototype samples available to the research team. Limiting one device for one patient with multiple drainage bags may not allow for accurate assessment of the B3 Buddy device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Device | Up to 17 minutes | The proportion of patients who find the device acceptable will be determined with the Acceptability of Implementation Measure tool. he AIM has 4 Likert items, ranging from 1 (for completely disagree) to 5 (for completely agree). A higher number indicates greater acceptability. If a patient marked 3 or more items with at least a 4, the device was considered acceptable. The device will be considered acceptable if at least 70% of patient participants find the device acceptable, which will be calculated by survey responses. |
| Usability of Device | Up to 20 minutes | Clinicians perception of usability will be determined with the System Usability Scale. The System Usability Scale score ranges from 0 to 100, where 100 represents the highest possible perceived usability. The device will be considered usable if the overall mean score is 68 or greater, which will be calculated by survey responses. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinicians (B3 Buddy) Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study.
Assistance: Assist patient with walking approximately 90 feet
Educational Intervention: Receive a short instructional session
Medical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device
Questionnaire Administration: Ancillary studies
Remove: Remove the device and return urinary drainage bag to the standard position | 20 |
| Patients (B3 Buddy) Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study.
Educational Intervention: Receive a short instructional session
Medical Device Usage and Evaluation: Wear the B3 Buddy device
Questionnaire Administration: Ancillary studies
Walking: Walk approximately 90 feet | 21 |
| Total | 41 |
Baseline characteristics
| Characteristic | Patients (B3 Buddy) | Total | Clinicians (B3 Buddy) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 15 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 26 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 41 Participants | 20 Participants |
| 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 | 0 Participants | 0 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 | 21 Participants | 41 Participants | 20 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 21 participants | 41 participants | 20 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | — |
| Sex: Female, Male Male | 15 Participants | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Acceptability of Device
The proportion of patients who find the device acceptable will be determined with the Acceptability of Implementation Measure tool. he AIM has 4 Likert items, ranging from 1 (for completely disagree) to 5 (for completely agree). A higher number indicates greater acceptability. If a patient marked 3 or more items with at least a 4, the device was considered acceptable. The device will be considered acceptable if at least 70% of patient participants find the device acceptable, which will be calculated by survey responses.
Time frame: Up to 17 minutes
Population: Acceptability of device was only measured for patient arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients (B3 Buddy) | Acceptability of Device | 100 percentage of participants |
Primary
Usability of Device
Clinicians perception of usability will be determined with the System Usability Scale. The System Usability Scale score ranges from 0 to 100, where 100 represents the highest possible perceived usability. The device will be considered usable if the overall mean score is 68 or greater, which will be calculated by survey responses.
Time frame: Up to 20 minutes
Population: Usability of device was only measured for the clinician arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Clinicians (B3 Buddy) | Usability of Device | 90.1 score on a scale |