Trial Outcomes & Findings for GEBT Telehealth Administration Usability Study (NCT NCT04684992)

NCT ID: NCT04684992

Last Updated: 2021-08-24

Results Overview

Ability to prepare GEBT will be assessed by the telehealth administrator's observation of the patient.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2021-08-24

Participant Flow

Participant milestones

Measure	GEBT Telehealth Administration Usability Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Overall Study STARTED	36
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Age, Categorical <=18 years	0 Participants n=34 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=34 Participants
Age, Categorical >=65 years	3 Participants n=34 Participants
Sex: Female, Male Female	22 Participants n=34 Participants
Sex: Female, Male Male	12 Participants n=34 Participants

PRIMARY outcome

Timeframe: 1 day

Ability to prepare GEBT will be assessed by the telehealth administrator's observation of the patient.

Outcome measures

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions Transfer meal to cooking cup without spilling	34 participants
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions Remove oxygen absorber	34 participants
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions Added correct amount of water	34 participants
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions Egg meal cooked for correct length of time	34 participants
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions Egg flipped middle of cooking	34 participants
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions Egg appeared adequately cooked	34 participants

PRIMARY outcome

Timeframe: up to 1 week

Population: Study participants assessed on a patient questionnaire whether the meal preparation instructions were clear and easy to follow.

Ability to prepare GEBT will be assessed by a patient questionnaire.

Outcome measures

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions	34 participants

PRIMARY outcome

Timeframe: 2-4 days

Ability to complete the GEBT test request form will be assessed by Cairn accessioning personnel upon receipt of returned breath samples.

Outcome measures

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions Test Request Form returned with samples	34 participants
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions Patient Information Entered Correctly	33 participants
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions Pre-meal sample times recorded	33 participants
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions Meal start/end times recorded correctly	34 participants
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions Post-meal sample times recorded	34 participants

PRIMARY outcome

Timeframe: up to 1 week

Population: Participants assessed easy of completing the GEBT test request form.

Ability to complete the GEBT test request form will be assessed by a patient questionnaire.

Outcome measures

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions	34 participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional Telehealth administrator observed condensate	33 participants
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional Post meal samples collected within 5 minutes	33 participants
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional Clinical lab personnel observed condensate	34 participants
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional Adequate %CO2 (>1%)	34 participants
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional Samples follow excretion curve shape	34 participants
Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional Breath samples easy to collect	34 participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Ability to Successfully Ship Kits/Breath Samples to/From Home Kit arrived before test administration	34 participants
Ability to Successfully Ship Kits/Breath Samples to/From Home Breath samples received within 28-days	34 participants

PRIMARY outcome

Timeframe: 1 day

Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a telehealth administrator questionnaire

Outcome measures

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Ability of a Telehealth Platform to Function Correctly No platform issues?	32 participants
Ability of a Telehealth Platform to Function Correctly No lost connection?	32 participants
Ability of a Telehealth Platform to Function Correctly No text reminder issues?	31 participants

PRIMARY outcome

Timeframe: Up to 3 weeks

Population: Participants assessed reliability and ease of use of telehealth platform.

Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a patient questionnaire

Outcome measures

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Ability of a Telehealth Platform to Function Correctly	32 participants

PRIMARY outcome

Timeframe: Up to 3 weeks

Population: There were no adverse events associated with telehealth administration via the telehealth procedure (e.g., burns during microwave cooking or injuries from breath collection apparatus).

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.

Outcome measures

Measure	GEBT Telehealth Administration Usability n=34 Participants Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility	0 AEs associated with telehealth

Adverse Events

GEBT Telehealth Administration Usability

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GEBT Telehealth Administration Usability n=34 participants at risk Establish the usability of a telehealth platform for the administration of GEBT GEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT
Gastrointestinal disorders Excessive burping and nausea	2.9% 1/34 • 3 months
Gastrointestinal disorders Severe bloating and excessive gas	2.9% 1/34 • 3 months
Gastrointestinal disorders Vomiting and dehydration	2.9% 1/34 • 3 months

Additional Information

Chief Scientist and Compliance Officer

Cairn Diagnostics

Phone: 615-376-5464

Email: cwilliams@cairndx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place