Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)

Study Overview
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Brief Summary
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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.

Official Title
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Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)

Conditions
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Fluid Output

Intervention / Treatment
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* Device: Electronic Device for Toilet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Patients use toilet device to measure fluid output and self-report event types | Device: Electronic Device for Toilet<br>* Device will be installed on toilet of patients will in hospital to measure all waste output.<br>|
| No Intervention: Control<br>Collection in standard hats + nurses visually assessing fluid volumes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 perceived lower chemotherapy exposure as measured by survey |  | After transition to Stage 2 - about 3 days after patient begins 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toilet device