Status:
RECRUITING
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
Lead Sponsor:
The University of Queensland
Collaborating Sponsors:
Princess Alexandra Hospital, Brisbane, Australia
Macquarie University, Australia
Conditions:
Gastrointestinal Diseases
Irritable Bowel Syndrome
Eligibility:
All Genders
18-90 years
Phase:
NA
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 sym...
Detailed Description
An Effectiveness-Implementation Hybrid Design with a two stage randomisation will be used to determine and compare efficacy and cost-effectiveness of different management approaches/interventions for ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05274854
Start Date
May 1 2023
End Date
December 31 2025
Last Update
November 12 2024
Active Locations (1)
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1
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102