Duke University
Durham, North Carolina, 27705, United States
Location status: Recruiting
Recruiting
NCT Number: NCT05520346
Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Electronic Device for Toilet
DeviceDevice will be installed on toilet of patients will in hospital to measure all waste output.
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
Time frame: Up to 14 days
-
Mean absolute error of urine volume (in mL) as measured by device
Time frame: Up to 14 days
-
Time (in mins) spent handling/recording patient waste
Time frame: First 3 days of patient's HCT conditioning
-
Levels of chemotherapy drugs detectable on room surfaces as measured by surface testing
Time frame: 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
Time frame: Up to 14 days
-
Percent device can correctly identify diarrhea events
Time frame: Up to 14 days
-
Percent of patients who indicated device satisfaction as measured by patient survey
Time frame: Day 3 of HCT conditioning
-
Percent of nurses who perceived lower chemotherapy exposure as measured by survey
Time frame: 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
Time frame: After transition to Stage 2 - about 3 days after patient begins HCT conditioning
-
Number of patient falls as measured by patient report
Time frame: Up to 17 days
Study contacts
Contact information is provided by the study sponsor or research team.
Amy Bush
CONTACT
Lauren Hill
CONTACT
Sponsors and collaborators
Lead sponsor
Duke University
Other
Registry information
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 29, 2022
- Registry last updated
- Feb 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.