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

Overview

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 rooms 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.

Interventions

• Device Electronic Device for Toilet
  Device will be installed on toilet of patients will in hospital to measure all waste output.

Primary outcome measures

• 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 outcome measures (10)

• 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]

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 OR currently undergoing treatment for HF in the Duke Cardiology Clinic with order of strict I/O monitoring
• Age 18-80 years
• Karnofsky Performance Scale (KPS) ≥ 70 if a BMT patient
• 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 OR during HF treatment.
• Women who are pregnant
• Patient height < 5'3" if they are a patient within the Duke Cardiology Clinic
• Disabled individuals using wheelchairs or transfer devices to use bathroom

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Duke University — Durham

Identifiers

NCT: NCT05520346 · Pro00107848

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗