Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Device
Patients use toilet device to measure fluid output and self-report event types
干预措施: Electronic Device for Toilet (Device)
Control
Collection in standard hats + nurses visually assessing fluid volumes
结局指标
主要结局
Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment
时间窗: Up to 14 days
次要结局
- 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)
- 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 of patients who indicated device satisfaction as measured by patient survey(Day 3 of 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)