Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment
Study Overview
Brief Summary
The purpose of this study is to determine whether a prototype toilet device that we have developed can accurately and automatically track human fluid output from renal and gastrointestinal systems in the hospital. The device includes components that can be outfitted onto existing toilets.
In this study, participants' hospital rooms will be outfitted with the prototype toilet device. Participants will use the toilet as usual throughout the duration of their inpatient stay. Sometimes output will be measured by the device, and other times output will be measured manually by nurses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled to undergo an allogeneic or autologous hematopoietic stem cell transplant for any cancer or non-cancer illness through the Duke ABMT clinic OR currently undergoing treatment for HF in the Duke Cardiology Clinic with order of strict I/O monitoring
- •Age 18-80 years
- •Karnofsky Performance Scale (KPS) ≥ 70 if a BMT patient
- •Able to read/write English
Exclusion Criteria
- •Inability to use toilet device due to physical constraints, e.g. waste excreted through stoma or catheter.
- •Physician recommendation that patient does not use standard urine/stool collection hat during days 1-2 of HCT conditioning OR during HF treatment.
- •Women who are pregnant
- •Patient height < 5'3" if they are a patient within the Duke Cardiology Clinic
- •Disabled individuals using wheelchairs or transfer devices to use bathroom
Arms & Interventions
Device
Patients use toilet device to measure fluid output and self-report event types
Intervention: Electronic Device for Toilet (Device)
Control
Collection in standard hats + nurses visually assessing fluid volumes
Outcomes
Primary Outcomes
Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment
Time Frame: Up to 14 days
Secondary Outcomes
- Correlation between daily patient fluid balance (difference between fluid input and output in mL) as measured by device measurements or standard of care nurse assessment and the change in daily weight(Up to 14 days)
- Mean absolute error of urine volume (in mL) as measured by device(Up to 14 days)
- Time (in mins) spent handling/recording patient waste(First 3 days of patient's HCT conditioning)
- Time (in mins) between nurse logging of patient urination in electronic medical records and device-based logging of patient urination(Up to 14 days)
- Percent of patients who indicated device satisfaction as measured by patient survey(Day 3 of HCT conditioning)
- Percent of nurses who indicated device satisfaction as measured by nurse survey(After transition to Stage 2 - about 3 days after patient begins HCT conditioning)
- Number of patient falls as measured by patient report(Up to 17 days)