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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE
Enrollment
18
Participants will have an active device (i.e., ultrasound energy is being produced by actuator) attached to their urinary catheter tube.
Participants will have an inactive device (i.e., no ultrasound energy being produced by the actuator) attached to their urinary catheter tube. All other aspects of the sham device (look, weight, feel, sound, and operation) are identical to the active device.
Evangelical Home - Saline
Saline, Michigan, United States
Feasibility as Measured by Recruitment rate
Feasibility was determined by the number of participants enrolled out of the number of participants eligible to participate in the study.
Time frame: Summarized every month for 6 months, or until the recruitment goal is reached.
Device use adherence
Number of patients with at least 80% adherence out of total patients enrolled. Device adherence will be assessed via direct observation by study staff as well as patient/caregiver/clinician-reported (via written documentation or phone/email correspondence).
Time frame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Device accountability
Number of devices used out of the number of devices received. Extra components of the device (i.e., actuators) will be available to the study team; monitoring their use will validate amount and type of resources needed for intervention implementation.
Time frame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
Efficiency of data collection
Time required for survey completion and data abstraction via chart review (actual time/expected time).
Time frame: Summarized every month for at least 6 months, or until the recruitment goal is reached.
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