Evaluation of Quality-of-Life Improvements Using UroShield for Patients Living in Long Term Care Facilities With Indwelling Urinary Catheters - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol.
The main questions the investigators aim to answer focus on implementation and practicality:
- Recruitment feasibility and time to recruit
- How well do participants adhere to device protocol?
- How often do device components (i.e., actuators and drivers) have to be replaced?
- How much time is required for data collection and what sources or methods for data collection are used?
Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow.
详细描述
The UroShield® device works by generating ultrasonic waves to interfere with attachment of bacteria inside the catheter, preventing biofilm formation and subsequent infections.
This double-blind pilot study aims to recruit 10-20 participants with urinary catheters (urethral or suprapubic catheters) living in nursing homes (NHs) in Michigan. Participants providing consent will be randomized to either the treatment or control group and will have either an active treatment UroShield® device attached or a sham UroShield® device attached to the external tubing of their urinary catheter. Participants will wear the device continuously for a maximum of 90 days. Assessments of pain and quality-of-life will be conducted by study staff over a maximum of 6 study visits, along with clinical data collection via medical record review. A urine sample and catheter sample will also be collected by study staff at each catheter change (approximately every 30 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age 18+
- •Indwelling urinary catheter (urethral or suprapubic) in place
- •Written informed consent (and assent, when applicable) obtained from participant or participant's legal representative
- •Able to comply with the requirements of the study
排除标准
- •Pregnant or breastfeeding women
- •Antibiotic use in past 10 days
- •Ineligible catheter type in place (e.g., antimicrobial coated, 3-way catheter, condom catheter, nephrostomy tube, wicking device)
- •Participation in another drug or device study in past 30 days
- •History of poor compliance to medical treatment regimens
- •Conditions that may severely compromise their ability to complete the study
研究组 & 干预措施
Active UroShield
Active UroShield Device
干预措施: Active UroShield (Device)
Sham UroShield
Inactive UroShield device
干预措施: Sham UroShield (Device)
结局指标
主要结局
Recruitment rate
时间窗: Summarized every month for 6 months, or until the recruitment goal is reached.
Number of patients enrolled out of number of patients eligible to participate in the study.
Feasibility as Measured by Recruitment rate
时间窗: Summarized every month for 6 months, or until the recruitment goal is reached.
Feasibility was determined by the number of participants enrolled out of the number of participants eligible to participate in the study.
次要结局
- Efficiency of data collection(Summarized every month for at least 6 months, or until the recruitment goal is reached.)
- Device accountability(Summarized every month for at least 6 months, or until the recruitment goal is reached.)
- Device use adherence(Summarized every month for at least 6 months, or until the recruitment goal is reached.)
研究者
Lona Mody
Principal Investigator, Professor of Internal Medicine
University of Michigan