Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000443695
Ethics application status
Approved
Date submitted
4/04/2023
Date registered
1/05/2023
Date last updated
1/05/2023
Date data sharing statement initially provided
1/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Longitudinal outcomes after Gastric Alimetry™ testing
Scientific title
Longitudinal outcome monitoring in patients with chronic gastroduodenal symptoms investigated using the Gastric Alimetry™ system
Secondary ID [1] 309313 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroduodenal disorders 329616 0
Condition category
Condition code
Oral and Gastrointestinal 326541 326541 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All consecutive adults undergoing Gastric Alimetry(TM) testing.

For participants the study involves undergoing the Gastric Alimetry(TM) test (4.5 hour recording using the Gastric Alimetry Array and Reader with a Ensure drink and Oatmeal bar meal stimulus at 30 minutes, followed by 4 hours of postprandial recording). Participants will complete baseline questionnaires during the test. Participants will then receive email/text reminders to complete the questionnaires on their mobile phone (MyCap App) if they provide informed consent for the longitudinal study.

Observations include Gastric Alimetry(TM) test report (electrophysiology, spatial and spectral metrics, symptoms) and patient reports outcomes including symptom severity scales, quality of life, and health psychology questionnaires.

Quality of life will be assessed via EuroQol-5D (EQ-5D) and the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) score. Gastrointestinal symptoms will be assessed via the Patient Assessment of Upper Gastrointestinal Symptom Severity (PAGI-SYM) index, and the Gastroparesis Cardinal Symptom Index (GCSI). Anxiety will be assessed through the General Anxiety Disorder-7 (GAD-7), perceived stress using the Perceived Stress Scale 4 (PSS-4), and depression via the Patient Health Questionnaire 9 (PHQ-9). Clinical parameters including, diagnoses (Gastric Alimetry™ phenotype, Rome-IV diagnosis), investigations (gastric emptying, transit studies, manometry, endoscopy), and treatments (medications, and procedures), as well as changes in the above measures, and date of change will also be captured.

At each of the post-test time points (index test, 30-days, 90-days, 180-days and 365-days), participants will be asked to complete a daily symptom diary for seven days. Each evening, they will rate the severity of seven gastrointestinal symptoms over the past 24 hours. Each symptom is rated using a 0–10 Likert scale, with anchors at 0 “none,” indicating no symptom experience, and 10 indicating the “most severe imaginable” extent of a symptom experience. The rating is determined by the worst symptom experience in the past 24 hours for each symptom. The symptoms are stomach burn, stomach pain, nausea, bloating, postprandial fullness, early satiation, belching, and number of vomiting events. An additional rating distress arising from excessive belching is included, using a 0-10 Likert scale, with anchors at 0 “none,” and 10 “worst imaginable bother.”

Enrolled participants will be followed up for a total of 1 year.


Planned comparisons include between patients with chronic gastroduodenal disorders (e.g., chronic nausea vomiting syndromes and functional dyspepsia as defined by Rome-IV, healthy volunteers, and those with and without gastroparesis).


MyCap is a readily available resource (add-on to REDCap: https://projectmycap.org/).
It is anticipated that 15-30 minutes will be needed to finish the baseline questionnaires and 5-10 minutes for subsequent follow-up questionnaires.
Intervention code [1] 325821 0
Diagnosis / Prognosis
Comparator / control treatment
No control group (however, comparisons between different disease groups will be made). However asymptomatic participants / healthy volunteers that undergo Gastric Alimetry (TM) testing are also eligible to be included and may contribute to reference / control groups in future analyses.
Control group
Active

Outcomes
Primary outcome [1] 334379 0
Feasibility of longitudinal follow-up of a cohort that have undergone Gastric Alimetry™ testing; from which patients’ continuum of care can be characterised.

This will be assessed by the percentage of all data points that are completed by patients (based on data exported from the REDCap database).
Timepoint [1] 334379 0
365 days post-Gastric Alimetry testing
Secondary outcome [1] 420440 0
Quality of life will be assessed via EuroQol-5D (EQ-5D) via MyCap App
Timepoint [1] 420440 0
Time of Gastric Alimetry test, 30-days, 90-days, 180-days, and 365-days after test.
Secondary outcome [2] 420742 0
Quality of life related to gastrointestinal health as measured by PAGI-QoL questionnaire via MyCap
Timepoint [2] 420742 0
Time of Gastric Alimetry test, 30-days, 90-days, 180-days, and 365-days after test.
Secondary outcome [3] 420743 0
Patient Assessment of Upper Gastrointestinal Symptom Severity (PAGI-SYM) index via MyCap App
Timepoint [3] 420743 0
Time of Gastric Alimetry test, 30-days, 90-days, 180-days, and 365-days after test.
Secondary outcome [4] 420744 0
Gastroparesis Cardinal Symptom Index (GCSI) via MyCap App
Timepoint [4] 420744 0
Time of Gastric Alimetry test, 30-days, 90-days, 180-days, and 365-days after test.
Secondary outcome [5] 420780 0
General Anxiety Disorder-7 (GAD-7) via MyCap App
Timepoint [5] 420780 0
Time of Gastric Alimetry test, 30-days, 90-days, 180-days, and 365-days after test.
Secondary outcome [6] 420781 0
Perceived Stress Scale 4 (PSS-4) via myCap App
Timepoint [6] 420781 0
Time of Gastric Alimetry test, 30-days, 90-days, 180-days, and 365-days after test.
Secondary outcome [7] 420782 0
Patient Health Questionnaire 9 (PHQ-9) via MyCap App
Timepoint [7] 420782 0
Time of Gastric Alimetry test, 30-days, 90-days, 180-days, and 365-days after test.

Eligibility
Key inclusion criteria
All adults aged 18 years and above consenting to a Gastric Alimetry™ test are eligible for inclusion. No exclusions will be made based on the clinical management of patients as for each intervention, a series of ‘exposed’ (e..g, patients with clinical gastroduodenal disorders such as chronic nausea and vomiting syndromes, functional dyspepsia, post-surgical gastric dysfunction) and ‘controlled’ (healthy volunteers, asymptomatic control participants) participants will be required to assess causal relationships. Healthy volunteers that consent can also be included to form a comparator arm for analyses.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include: age <18 years, history of skin allergies or a history of extreme sensitivity to cosmetics or lotions, and vulnerable groups such as prisoners, individuals known to have cognitive impairment or institutionalised individuals.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Exploratory and pilot analyses will be performed within acknowledged limitations of a non-randomised study design. Longitudinal assessments allow for the evaluation of the efficacy and utility of diagnostic assessments and treatments offered to patients. Monitoring within-subject-changes has been shown to offer advantages in establishing causal relationships. As data accrues over time, a large repository of longitudinal data will be available to compare the impacts of investigations, medication changes, and procedural interventions on patient-reported outcomes. Such causal inferences can lay the foundation for future randomised trials, informing power calculations, and identifying research priorities.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/03/2023
Date of last participant enrolment
Anticipated
29/03/2024
Actual
Date of last data collection
Anticipated
29/03/2025
Actual
Sample size
Target
100
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24476 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 40060 0
2560 - Campbelltown
Recruitment outside Australia
Country [1] 25376 0
Canada
State/province [1] 25376 0
Calgary
Country [2] 25377 0
New Zealand
State/province [2] 25377 0
Auckland

Funding & Sponsors
Funding source category [1] 313509 0
Government body
Name [1] 313509 0
New Zealand Health Research Council
Country [1] 313509 0
New Zealand
Funding source category [2] 313583 0
Government body
Name [2] 313583 0
National Institutes of Health
Country [2] 313583 0
United States of America
Primary sponsor type
University
Name
University of Auckland
Address
20 Symonds Street Auckland 1010. New Zealand
Country
New Zealand
Secondary sponsor category [1] 315368 0
None
Name [1] 315368 0
NA
Address [1] 315368 0
NA
Country [1] 315368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312694 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 312694 0
20 Symonds Street Auckland 1010. New Zealand
Ethics committee country [1] 312694 0
New Zealand
Date submitted for ethics approval [1] 312694 0
08/02/2023
Approval date [1] 312694 0
16/02/2023
Ethics approval number [1] 312694 0
AH1130

Summary
Brief summary
Introduction
The Gastric AlimetryTM platform offers a multimodal assessment of gastric function through body surface gastric mapping (BSGM) and concurrent symptom-tracking via a validated App. We aim to perform a longitudinal cohort study to examine the impact of Gastric Alimetry, and changes in clinical management on patient symptoms, quality of life, and psychological health.

Methods
This is a prospective multicentre longitudinal observational cohort study of participants with chronic gastroduodenal symptoms. Consecutive participants undergoing Gastric Alimetry™ will be invited to participate. Quality of life will be assessed via EuroQol-5D and the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) score. Gastrointestinal symptoms will be assessed via the Patient Assessment of Upper Gastrointestinal Symptom Severity (PAGI-SYM) index, and the Gastroparesis Cardinal Symptom Index (GCSI). Psychometrics will be assessed, including anxiety via the General Anxiety Disorder-7 (GAD-7), perceived stress using the Perceived Stress Scale 4 (PSS-4), and depression via the Patient Health Questionnaire 9 (PHQ-9). Clinical parameters including diagnoses, investigations, and treatments (medication and procedures) will also be captured. Assessments will be made the week after the BSGM test, at 30-days, 90-days, 180-days, and 360-days thereafter.

Analysis
The primary outcome is feasibility of longitudinal follow-up of a cohort that have undergone Gastric Alimetry™ testing; from which patients’ continuum of care can be characterised. Secondary outcomes include changes in patient-reported symptoms, quality of life, and psychometrics (anxiety, stress, and depression). Inferential causal analyses will be performed at the within patient-level to explore causal associations between treatment changes and clinical outcomes. The impact of Gastric Alimetry on clinical management will also be captured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125586 0
Prof Greg O'Grady
Address 125586 0
20 Symonds Street Auckland 1010. New Zealand
University of Auckland, Auckland, New Zealand
Country 125586 0
New Zealand
Phone 125586 0
+64 09 373 7599
Fax 125586 0
Email 125586 0
greg.ogrady@auckland.ac.nz
Contact person for public queries
Name 125587 0
Dr Chris Varghese
Address 125587 0
20 Symonds Street Auckland 1010. New Zealand
University of Auckland, Auckland, New Zealand
Country 125587 0
New Zealand
Phone 125587 0
+64 09 373 7599
Fax 125587 0
Email 125587 0
cvar706@aucklanduni.ac.nz
Contact person for scientific queries
Name 125588 0
Dr Chris Varghese
Address 125588 0
20 Symonds Street Auckland 1010. New Zealand
University of Auckland, Auckland, New Zealand
Country 125588 0
New Zealand
Phone 125588 0
+64 09 373 7599
Fax 125588 0
Email 125588 0
cvar706@aucklanduni.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data privacy.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.