Clinical trial NCT05520346: Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)
Official title: Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fluid Output
Keywords: toilet device
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment
timeFrame: Up to 14 days
Secondary outcomes:
measure: 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
timeFrame: Up to 14 days
measure: Mean absolute error of urine volume (in mL) as measured by device
timeFrame: Up to 14 days
measure: Time (in mins) spent handling/recording patient waste
timeFrame: First 3 days of patient's HCT conditioning
measure: Levels of chemotherapy drugs detectable on room surfaces as measured by surface testing
timeFrame: First 3 days of patient's HCT conditioning
measure: Time (in mins) between nurse logging of patient urination in electronic medical records and device-based logging of patient urination
timeFrame: Up to 14 days
measure: Percent device can correctly identify diarrhea events
timeFrame: Up to 14 days
measure: Percent of patients who indicated device satisfaction as measured by patient survey
timeFrame: Day 3 of HCT conditioning
measure: Percent of nurses who perceived lower chemotherapy exposure as measured by survey
timeFrame: After transition to Stage 2 - about 3 days after patient begins HCT conditioning
measure: Percent of nurses who indicated device satisfaction as measured by nurse survey
timeFrame: After transition to Stage 2 - about 3 days after patient begins HCT conditioning
measure: Number of patient falls as measured by patient report
timeFrame: Up to 17 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Chenyu Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: