Telehealth Administration of 13C-Spirulina Gastric Emptying Breath Test (13C-GEBT) Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional
研究概览
简要总结
The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT.
详细描述
This study is intended to demonstrate that the 13C-Spirulina Gastric Emptying Breath Test (GEBT) can be successfully administered via a telehealth platform. Telehealth administration of GEBT is where a trained Cairn employee uses a video link to remotely supervise the completion of the test request form, collection of breath samples, cooking and consumption of the test meal and return of breath samples by the patient to Cairn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, greater than or equal to 18 years of age at the time of signing the consent form, from healthy and intended use population (i.e. symptomatic for gastroparesis). Women of childbearing potential must not be pregnant at the time of GEBT administration.
- •Ability to eat test meal and provide breath samples
- •Access to a microwave oven at home
- •Internet connection and telehealth accessible device (smart phone/tablet/computer with visual and voice capability) at home
- •Environment to sit comfortably and quietly at home
排除标准
- •History or physical exam suggestive of systemic disease such as pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption syndrome
- •History of abdominal surgery except appendectomy
- •Females on hormone replacement therapy other than birth control medications
- •Receipt of any investigational drug within 4 weeks of the study
- •Pregnancy
- •Intolerance or allergy to any component of GEBT meal
- •History of neurological or psychiatric disorders
结局指标
主要结局
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional
时间窗: up to 1 week
Ability to collect GEBT breath samples will be assessed by examination of GEBT results for participants (ensuring adequate CO2 in each sample/delta values follow expected pattern if collected in correct order).
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions
时间窗: up to 1 week
Ability to complete the GEBT test request form will be assessed by a patient questionnaire.
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions
时间窗: up to 1 week
Ability to prepare GEBT will be assessed by a patient questionnaire.
Ability to Successfully Ship Kits/Breath Samples to/From Home
时间窗: Up to 3 weeks
Ability to ship GEBT kits/breath samples to/from home will be assessed by surveying patients regarding shipping and by recording the dates that kits were shipped and received
Ability of a Telehealth Platform to Function Correctly
时间窗: Up to 3 weeks
Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a patient questionnaire
Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility
时间窗: Up to 3 weeks
Any adverse events reported will be reviewed by Cairn's medical director to assess that there is no more than expected frequency of adverse events during administration of GEBT by a telehealth professional than would be expected during administration of GEBT in a clinician's facility. This will be performed by comparing the current rate of events in a physician's office versus under the supervision of a telehealth professional as identified through the risk analyses performed for GEBT administration.
次要结局
未报告次要终点