A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorThe University of Queensland
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing
- a) consultant-led outpatient clinic or b) a integrated care clinic
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
The University of Queensland
Lead sponsor
Princess Alexandra Hospital, Brisbane, Australia
Collaborator
Macquarie University, Australia
Collaborator
Source ClinicalTrials.gov