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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment [Срок оценки: Up to 14 days]

Вторичные конечные точки (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 [Срок оценки: Up to 14 days]
• Mean absolute error of urine volume (in mL) as measured by device [Срок оценки: Up to 14 days]
• Time (in mins) spent handling/recording patient waste [Срок оценки: First 3 days of patient's HCT conditioning]
• Levels of chemotherapy drugs detectable on room surfaces as measured by surface testing [Срок оценки: 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 [Срок оценки: Up to 14 days]
• Percent device can correctly identify diarrhea events [Срок оценки: Up to 14 days]
• Percent of patients who indicated device satisfaction as measured by patient survey [Срок оценки: Day 3 of HCT conditioning]
• Percent of nurses who perceived lower chemotherapy exposure as measured by survey [Срок оценки: 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 [Срок оценки: After transition to Stage 2 - about 3 days after patient begins HCT conditioning]
• Number of patient falls as measured by patient report [Срок оценки: Up to 17 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Duke University — Durham

Идентификаторы

NCT: NCT05520346 · Pro00107848

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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