RecruitingNot ApplicableNCT05274854

A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms

A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness

Sponsor

The University of Queensland

Enrollment

200 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Gastrointestinal Diseases Irritable Bowel Syndrome

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

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 Criteria4

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

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Interventions

BEHAVIORALa)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

BEHAVIORALa) 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