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.

Study Overview

• Status: Recruiting
• Conditions: Fluid Output
• Intervention / Treatment: Device: Electronic Device for Toilet

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Hill; Phone Number: 919-668-2369; Email: lauren.hill@duke.edu
• Study Contact Backup: Name: Amy Bush; Phone Number: +1 919 668 1085; Email: amy.bush@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University
      • Contact: Chenyu Lin; Phone Number: 919-668-1000; Email: chenyu.lin@duke.edu
      • Contact: Phone Number: +1 919 684 8964

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Chenyu Lin, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: toilet device
• Other Study ID Numbers: Pro00107848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No