Gastroparesis
Conditions
Keywords
Gastroenterology, Gastric emptying breath test, Telehealth
Brief summary
The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT.
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.
Interventions
DEVICEGEBT Telehealth Administration Usability
Establish the usability of a telehealth platform for the administration of GEBT
Sponsors
Cairn Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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 |
| 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | GEBT Telehealth Administration Usability | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 31 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 3 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GEBT Telehealth Administration Usability | Ability of a Telehealth Platform to Function Correctly | No platform issues? | 32 participants |
| GEBT Telehealth Administration Usability | Ability of a Telehealth Platform to Function Correctly | No lost connection? | 32 participants |
| GEBT Telehealth Administration Usability | Ability of a Telehealth Platform to Function Correctly | No text reminder issues? | 31 participants |
Primary
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
Population: Participants assessed reliability and ease of use of telehealth platform.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GEBT Telehealth Administration Usability | Ability of a Telehealth Platform to Function Correctly | 32 participants |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GEBT Telehealth Administration Usability | Ability to Successfully Ship Kits/Breath Samples to/From Home | Kit arrived before test administration | 34 participants |
| GEBT Telehealth Administration Usability | Ability to Successfully Ship Kits/Breath Samples to/From Home | Breath samples received within 28-days | 34 participants |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GEBT Telehealth Administration Usability | Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional | Telehealth administrator observed condensate | 33 participants |
| GEBT Telehealth Administration Usability | Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional | Post meal samples collected within 5 minutes | 33 participants |
| GEBT Telehealth Administration Usability | Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional | Clinical lab personnel observed condensate | 34 participants |
| GEBT Telehealth Administration Usability | Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional | Adequate %CO2 (>1%) | 34 participants |
| GEBT Telehealth Administration Usability | Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional | Samples follow excretion curve shape | 34 participants |
| GEBT Telehealth Administration Usability | Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional | Breath samples easy to collect | 34 participants |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GEBT Telehealth Administration Usability | 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 |
| GEBT Telehealth Administration Usability | 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 |
| GEBT Telehealth Administration Usability | 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 |
| GEBT Telehealth Administration Usability | 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 |
| GEBT Telehealth Administration Usability | 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
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
Population: Participants assessed easy of completing the GEBT test request form.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GEBT Telehealth Administration Usability | Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions | 34 participants |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GEBT Telehealth Administration Usability | 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 |
| GEBT Telehealth Administration Usability | 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 |
| GEBT Telehealth Administration Usability | 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 |
| GEBT Telehealth Administration Usability | 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 |
| GEBT Telehealth Administration Usability | 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 |
| GEBT Telehealth Administration Usability | 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
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
Population: Study participants assessed on a patient questionnaire whether the meal preparation instructions were clear and easy to follow.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GEBT Telehealth Administration Usability | Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions | 34 participants |
Primary
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
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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GEBT Telehealth Administration Usability | Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility | 0 AEs associated with telehealth |