Feasibility Testing of a Urinary Drainage Bag Securement Device to Improve Patient and Clinician Ambulation Experiences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Acceptability of Device
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Assistance (Other)
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.
干预措施: Educational Intervention (Other)
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.
干预措施: Medical Device Usage and Evaluation (Other)
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.
干预措施: Remove (Procedure)
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.
干预措施: Educational Intervention (Other)
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.
干预措施: Medical Device Usage and Evaluation (Device)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Walking (Other)
结局指标
主要结局
Acceptability of Device
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Karen Meade
Principal Investigator
Ohio State University Comprehensive Cancer Center