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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05274854




Registration number
NCT05274854
Ethics application status
Date submitted
7/02/2022
Date registered
11/03/2022
Date last updated
12/11/2024

Titles & IDs
Public title
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
Scientific title
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness
Secondary ID [1] 0 0
APP2004495
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Diseases 0 0
Irritable Bowel Syndrome 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 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
BEHAVIORAL - a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing
BEHAVIORAL - a) consultant-led outpatient clinic or b) a integrated care clinic

Experimental: Preconsultation Intervention - Pre-consultation intervention includes 4 arms ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing)

Experimental: Consultation Intervention - Consultation intervention includes 2 arms (a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial preconsultation intervention.


BEHAVIORAL: a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing
Pre consultation interventions consist of one of four intervention a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing

BEHAVIORAL: a) consultant-led outpatient clinic or b) a integrated care clinic
Consultation intervention consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [1] 0 0
Week 0
Primary outcome [2] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [2] 0 0
Week 8
Primary outcome [3] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [3] 0 0
Week 16
Primary outcome [4] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [4] 0 0
Week 20
Primary outcome [5] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [5] 0 0
Week 24
Primary outcome [6] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [6] 0 0
Week 28
Primary outcome [7] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [7] 0 0
Week 32
Primary outcome [8] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [8] 0 0
Week 35
Primary outcome [9] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [9] 0 0
Week 38
Primary outcome [10] 0 0
Structured Assessment of Gastrointestinal Symptoms score
Timepoint [10] 0 0
Week 44
Primary outcome [11] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [11] 0 0
Week 0
Primary outcome [12] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [12] 0 0
Week 8
Primary outcome [13] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [13] 0 0
Week 16
Primary outcome [14] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [14] 0 0
Week 20
Primary outcome [15] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [15] 0 0
Week 24
Primary outcome [16] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [16] 0 0
Week 28
Primary outcome [17] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [17] 0 0
Week 32
Primary outcome [18] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [18] 0 0
Week 35
Primary outcome [19] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [19] 0 0
Week 38
Primary outcome [20] 0 0
European Quality of Life Five Dimension (EQ-5D)
Timepoint [20] 0 0
Week 44
Primary outcome [21] 0 0
Cost effectiveness
Timepoint [21] 0 0
Week 0
Primary outcome [22] 0 0
Cost effectiveness
Timepoint [22] 0 0
Week 8
Primary outcome [23] 0 0
Cost effectiveness
Timepoint [23] 0 0
Week 16
Primary outcome [24] 0 0
Cost effectiveness
Timepoint [24] 0 0
Week 28
Primary outcome [25] 0 0
Cost effectiveness
Timepoint [25] 0 0
Week 44
Secondary outcome [1] 0 0
Hospital Anxiety and Depression Scale
Timepoint [1] 0 0
Week 0
Secondary outcome [2] 0 0
Hospital Anxiety and Depression Scale
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Hospital Anxiety and Depression Scale
Timepoint [3] 0 0
Week 28
Secondary outcome [4] 0 0
Hospital Anxiety and Depression Scale
Timepoint [4] 0 0
Week 44
Secondary outcome [5] 0 0
Microbiome
Timepoint [5] 0 0
Week 0
Secondary outcome [6] 0 0
Microbiome
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Microbiome
Timepoint [7] 0 0
Week 28
Secondary outcome [8] 0 0
Microbiome
Timepoint [8] 0 0
Week 44
Secondary outcome [9] 0 0
Acceptance of models of care by consumers and staff
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Acceptance of models of care by consumers and staff
Timepoint [10] 0 0
Week 28

Eligibility
Key inclusion criteria
* Patients with relevant, chronic, or relapsing gastrointestinal (GI) symptoms without concerning features and on the wait list for integrated care clinic (ICC) will be included in the study.
* Patients with severe symptoms as defined by a total Structured Assessment of Gastrointestinal Symptoms (SAGIS) score > 35
* Patients aged 18 years or older to 90 years old
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with 'alarm' signs or symptoms (significant unexplained weight loss, evidence for gastrointestinal bleeding, iron deficiency anaemia, new onset GI symptoms) will be triaged to undergo urgent clinical work-up before they can be considered for inclusion into the study
* Patients with mild or moderate symptoms (e.g. not requiring clinical work-up or who will likely spontaneously improve) will not be eligible for inclusion into the study and will be managed as clinically indicated.
* Patients with any comorbidities that would interfere with the objectives of these interventions will be managed via the routine clinical pathways.
* Patients with a prior history of any eating disorder, wait listed for bariatric surgery or have had bariatric surgery will be excluded

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Macquarie University, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This research project aims to test whether early interventions delivered remotely and prior to integrated care clinic appointments are effective. Patients with chronic unexplained gastrointestinal symptoms will initially undergo structured assessment of symptoms and wheat intolerance delivered remotely. Patients who continue to experience symptoms will then be randomised to a pre-consultation intervention ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) followed by randomisation to the consultation intervention ((a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial intervention.
Trial website
https://clinicaltrials.gov/study/NCT05274854
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerald Holtmann, MD PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gerald Holtmann, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
61 7 3176 7792
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05274854