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

Duke University

Status: Enrolling

Conditions: Fluid Output

Treatments: Device: Electronic Device for Toilet

Study type: Interventional

Funder types: Other

Identifiers

NCT05520346

Pro00107848

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Device

Experimental group

Description:

Patients use toilet device to measure fluid output and self-report event types

Treatment:

Device: Electronic Device for Toilet

Control

No Intervention group

Description:

Collection in standard hats + nurses visually assessing fluid volumes