Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000562673
Ethics application status
Approved
Date submitted
13/03/2023
Date registered
25/05/2023
Date last updated
5/10/2024
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Body Surface Gastric Mapping in a Multidisciplinary Integrated Care Pathway for Chronic Gastrointestinal Symptoms
Scientific title
Evaluation of Body Surface Gastric Mapping in a Multidisciplinary Integrated Care Pathway for Chronic Gastrointestinal Symptoms
Secondary ID [1] 308610 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional gastrointestinal disorders
 328501 0
Functional Dyspepsia
 328502 0
Chronic Nausea and Vomiting Syndrome

 328503 0
Gastroparesis 328504 0
Condition category
Condition code
Oral and Gastrointestinal 325530 325530 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be the Multidisciplinary Integrated Care Clinic Treatment Approach (HREC/2021/QMS/75204). Participants will undergo a multidisciplinary review session for approximately 1 hour prior to receiving their personalised treatment plan by all potential specialists (i.e. gastroenterologist, general practitioner, psychologists, dieticians and physiotherapists). A 12 week structured program is targeted towards patients who have failed to respond to standard medical therapy, and includes both pharmacological and psychological interventions, as well as dietary and exercise consultations as required. Patient care in HREC/2021/QMS/75204 will be tailored to individual needs as identified by the treating multidisciplinary team, which may include: pharmacological management, psychological care (cognitive behaviour therapy / Acceptance and Commitment Therapy/ relaxation techniques / mindfulness), dietician consultation to avoid dietary triggers, and exercise programs including cardiorespiratory, resistance, flexibility, balance, and/or neuromotor training. The intervention by allied health (psychology, diet or exercise physiology) will be 1 hour a week for up to 12 weeks and will be delivered face to face or via telehealth. Adherence will be monitored via clinician assessment notes.

The body surface gastric mapping (BSGM) procedure will be performed in accordance with established protocols [Varghese, 2022], within three weeks prior to subjects receiving their personalised treatment plans and will be performed by the clinical scientist. Before the BSGM test, medications affecting gastrointestinal motility will be discontinued for two days, and the intake of caffeine and nicotine will be avoided on the day of the test. An 8x8 electrode array, connected to a wearable reader, will be placed on the epigastric area. The BSGM test will consist of a 30-minute fasting period, a 10 minute test meal, and a subsequent four-hour postprandial period. Patients will be instructed to maintain a comfortable position, limit their movements, and document symptoms using the Gastric Alimetry App [Sebaratnam 2022]. Continuous symptoms like nausea, bloating, upper gut pain, heartburn, stomach burn, and excessive fullness will be recorded at a minimum of 15-minute intervals using 10-point Likert scales. Early satiation will be measured immediately after the meal with a similar scale, while episodic symptoms, such as reflux, belching, and vomiting, will be logged as distinct events [Sebaratnam 2022].

References:
- Varghese C, et al. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2022 Dec 20. doi: 10.14309/ajg.0000000000002077. Epub ahead of print. PMID: 36534985.
- Sebaratnam G, et al. Standardized system and App for continuous patient symptom logging in gastroduodenal disorders: Design, implementation, and validation. Neurogastroenterology & Motility 2022;34:e14331
Intervention code [1] 325058 0
Treatment: Other
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333368 0
Total Symptom Burden Score derived from the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS)
Timepoint [1] 333368 0
Pre- and post-intervention (post completion of the 12 week intervention)
Secondary outcome [1] 416768 0
Depression using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [1] 416768 0
Pre- and post-intervention (post completion of the 12 week intervention)
Secondary outcome [2] 416769 0
Health-related quality of life measured using the 36-Item Short from Survey (SF-36)
Timepoint [2] 416769 0
Pre- and post-intervention (post completion of the 12 week intervention)
Secondary outcome [3] 416772 0
Diagnosis of functional gastrointestinal disorders, measured via the Digestive Health and Wellbeing Survey
Timepoint [3] 416772 0
Pre- and post-intervention (post completion of the 12 week intervention)
Secondary outcome [4] 421487 0
Anxiety using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [4] 421487 0
Pre- and post-intervention (post completion of the 12 week intervention)

Eligibility
Key inclusion criteria
All consenting patients aged over 18 years presenting to the Department of Gastroenterology & Hepatology at the Princess Alexandra Hospital referred to, and willing to participate in, the Integrated Care Clinic project (HREC/2021/QMS/75204- A practice change for patients with severe chronic, clinically unexplained gastrointestinal symptoms: A randomised, controlled intervention to assess efficacy and cost-effectiveness) at Princess Alexandra Hospital. This is a per-protocol analysis and only patients completing the intervention 12 week course will be included in the analyses. Patients not completing the recommended multidisciplinary course (estimated at ~35% of entering patients) will be noted for completeness but their results will not be evaluated.
Patients with BMI>35 may be included in the study for secondary subgroup analyses, but will be excluded from analyses involving GA-RI or reference intervals.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications for Gastric Alimetry testing, including damaged or fragile epigastric skin, adhesive allergy, or inability to sit still for a period of testing (e.g. marked tremor).
Participants who are pregnant will be excluded from this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To achieve an expected correlation coefficient of 0.35, for an alpha of 0.05 and a beta of 0.2, a sample size of 62 subjects would be required.

Fisher’s exact test for Body Surface Gastric Mapping (BSGM) normal vs abnormal (based on reference interval comparison of GA-RI and frequency) vs true/false for clinically important change in SAGIS score (8 points reduction).
Also comparison of BSGM normal vs abnormal test result vs change in the number of SAGIS items scored moderate or above post vs pre-intervention (indicates ‘problems that cannot be ignored’).
BSGM test data vs change in other symptom values and quality of life scores as available.
Correlation of Gastric Alimetry Rhythm Index (GA-RI) vs change in Hospital Anxiety and Depression Scale post vs pre intervention.
Fisher’s exact test for BSGM normal vs abnormal test outcome vs true/false for a clinically important change in HADS Score post intervention (1.5 point reduction in HADS-A or HADS-D) Exploratory secondary analyses will be performed on patient subgroups by Rome disorder, BSGM phenotypes and gastric emptying outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
25/04/2026
Actual
Sample size
Target
62
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23716 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 39152 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 312854 0
Commercial sector/Industry
Name [1] 312854 0
Alimetry Ltd.
Country [1] 312854 0
New Zealand
Primary sponsor type
Hospital
Name
Metro South Hospital and Health Service
Address
199 Ipswich Rd, Woolloongabba QLD 4102, Australia
Country
Australia
Secondary sponsor category [1] 314504 0
None
Name [1] 314504 0
Address [1] 314504 0
Country [1] 314504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312131 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 312131 0
Ethics committee country [1] 312131 0
Australia
Date submitted for ethics approval [1] 312131 0
17/08/2022
Approval date [1] 312131 0
11/11/2022
Ethics approval number [1] 312131 0
HREC/2022/QMS/89391

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123590 0
Prof Gerald Holtmann
Address 123590 0
Princess Alexandra Hospital,
199 Ipswich Rd, Woolloongabba QLD 4102, Australia
Country 123590 0
Australia
Phone 123590 0
+61 07 31767792
Fax 123590 0
Email 123590 0
[email protected]
Contact person for public queries
Name 123591 0
Gerald Holtmann
Address 123591 0
Princess Alexandra Hospital,
199 Ipswich Rd, Woolloongabba QLD 4102, Australia
Country 123591 0
Australia
Phone 123591 0
+61 07 31767792
Fax 123591 0
Email 123591 0
[email protected]
Contact person for scientific queries
Name 123592 0
Gerald Holtmann
Address 123592 0
Princess Alexandra Hospital,
199 Ipswich Rd, Woolloongabba QLD 4102, Australia
Country 123592 0
Australia
Phone 123592 0
+61 07 31767792
Fax 123592 0
Email 123592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be de-identified and presented as aggregate statistics. No data that could potentially identify any individual participants will be published or distributed.


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.