GEBT Telehealth Administration Usability Study

• Sponsor: Cairn Diagnostics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04684992
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 12.3

Study Details

Study Description

Brief Summary

The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Device: GEBT Telehealth Administration Usability	N/A

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Telehealth Administration of 13C-Spirulina Gastric Emptying Breath Test (13C-GEBT) Usability Study
• Actual Study Start Date: Dec 11, 2020
• Actual Primary Completion Date: Mar 10, 2021
• Actual Study Completion Date: Mar 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GEBT Telehealth Administration Usability Establish the usability of a telehealth platform for the administration of GEBT	Device: GEBT Telehealth Administration Usability; Establish the usability of a telehealth platform for the administration of GEBT

Outcome Measures

Primary Outcome Measures

1. Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions [1 day]

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

2. Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions [up to 1 week]

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

3. Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions [2-4 days]

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

4. Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions [up to 1 week]

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

5. Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional [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).

6. Ability to Successfully Ship Kits/Breath Samples to/From Home [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

7. Ability of a Telehealth Platform to Function Correctly [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

8. Ability of a Telehealth Platform to Function Correctly [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

9. Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairn Diagnostics	Brentwood	Tennessee	United States	37027

Sponsors and Collaborators

• Cairn Diagnostics

Investigators

• Principal Investigator: Alex Ryder, MD, PhD, Cairn Diagnostics

Study Documents (Full-Text)

• Study Protocol - Dec 14, 2020

More Information

Publications

None provided.

• Responsible Party: Cairn Diagnostics
• ClinicalTrials.gov Identifier: NCT04684992
• Other Study ID Numbers: PRO-CD-046
• First Posted: Dec 28, 2020
• Last Update Posted: Aug 24, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Cairn Diagnostics: Gastroenterology; Gastric emptying breath test; Telehealth
• Additional relevant MeSH terms: Gastroparesis

Study Results

Participant Flow

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Period Title: Overall Study
STARTED	36
COMPLETED	34
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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 Participants	34
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	31 91.2%
>=65 years	3 8.8%
Sex: Female, Male (Count of Participants)
Female	22 64.7%
Male	12 35.3%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions
Description	Ability to prepare GEBT will be assessed by the telehealth administrator's observation of the patient.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Measure Participants	34
Transfer meal to cooking cup without spilling	34 100%
Remove oxygen absorber	34 100%
Added correct amount of water	34 100%
Egg meal cooked for correct length of time	34 100%
Egg flipped middle of cooking	34 100%
Egg appeared adequately cooked	34 100%

2. Primary Outcome

Title	Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions
Description	Ability to prepare GEBT will be assessed by a patient questionnaire.
Time Frame	up to 1 week

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Measure Participants	34
Number [participants]	34 100%

3. Primary Outcome

Title	Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Measure Participants	34
Test Request Form returned with samples	34 100%
Patient Information Entered Correctly	33 97.1%
Pre-meal sample times recorded	33 97.1%
Meal start/end times recorded correctly	34 100%
Post-meal sample times recorded	34 100%

4. Primary Outcome

Title	Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions
Description	Ability to complete the GEBT test request form will be assessed by a patient questionnaire.
Time Frame	up to 1 week

Outcome Measure Data

Analysis Population Description

Participants assessed easy of completing the GEBT test request form.

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Measure Participants	34
Number [participants]	34 100%

5. Primary Outcome

Title	Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Measure Participants	34
Telehealth administrator observed condensate	33 97.1%
Post meal samples collected within 5 minutes	33 97.1%
Clinical lab personnel observed condensate	34 100%
Adequate %CO2 (>1%)	34 100%
Samples follow excretion curve shape	34 100%
Breath samples easy to collect	34 100%

6. Primary Outcome

Title	Ability to Successfully Ship Kits/Breath Samples to/From Home
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Measure Participants	34
Kit arrived before test administration	34 100%
Breath samples received within 28-days	34 100%

7. Primary Outcome

Title	Ability of a Telehealth Platform to Function Correctly
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Measure Participants	34
No platform issues?	32 94.1%
No lost connection?	32 94.1%
No text reminder issues?	31 91.2%

8. Primary Outcome

Title	Ability of a Telehealth Platform to Function Correctly
Description	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

Outcome Measure Data

Analysis Population Description

Participants assessed reliability and ease of use of telehealth platform.

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Measure Participants	34
Number [participants]	32 94.1%

9. Primary Outcome

Title	Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility
Description	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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
Measure Participants	34
Number [AEs associated with telehealth]	0

Adverse Events

Time Frame	3 months
Arm/Group Title	GEBT Telehealth Administration Usability
Arm/Group Description	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
All Cause Mortality
	GEBT Telehealth Administration Usability
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Serious Adverse Events
	GEBT Telehealth Administration Usability
	Affected / at Risk (%)	# Events
Total	0/34 (0%)
Other (Not Including Serious) Adverse Events
	GEBT Telehealth Administration Usability
	Affected / at Risk (%)	# Events
Total	3/34 (8.8%)
Gastrointestinal disorders
Excessive burping and nausea	1/34 (2.9%)
Severe bloating and excessive gas	1/34 (2.9%)
Vomiting and dehydration	1/34 (2.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.