The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
36
Establish the usability of a telehealth platform for the administration of GEBT
Cairn Diagnostics
Brentwood, Tennessee, United States
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions
Ability to prepare GEBT will be assessed by the telehealth administrator's observation of the patient.
Time frame: 1 day
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions
Ability to prepare GEBT will be assessed by a patient questionnaire.
Time frame: up to 1 week
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions
Ability to complete the GEBT test request form will be assessed by Cairn accessioning personnel upon receipt of returned breath samples.
Time frame: 2-4 days
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions
Ability to complete the GEBT test request form will be assessed by a patient questionnaire.
Time frame: up to 1 week
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional
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).
Time frame: up to 1 week
Ability to Successfully Ship Kits/Breath Samples to/From Home
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
Time frame: Up to 3 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ability of a Telehealth Platform to Function Correctly
Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a telehealth administrator questionnaire
Time frame: 1 day
Ability of a Telehealth Platform to Function Correctly
Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a patient questionnaire
Time frame: Up to 3 weeks
Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility
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.
Time frame: Up to 3 weeks