Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)
Not Applicable
Recruiting
- Conditions
- Fluid Output
- Interventions
- Device: Electronic Device for Toilet
- Registration Number
- NCT05520346
- Lead Sponsor
- Duke University
- 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 room 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 54
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
- Age 18-80 years
- Karnofsky Performance Scale KPS ≥ 70
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device Electronic Device for Toilet Patients use toilet device to measure fluid output and self-report event types
- Primary Outcome Measures
Name Time Method Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment Up to 14 days
- Secondary Outcome Measures
Name Time Method 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 Levels of chemotherapy drugs detectable on room surfaces as measured by surface testing 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 nurses who perceived lower chemotherapy exposure as measured by survey After transition to Stage 2 - about 3 days after patient begins HCT conditioning Percent device can correctly identify diarrhea events 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
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States