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

NCT ID: NCT05274854

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-12-31

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.

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 patients with relevant, chronic, or relapsing gastrointestinal symptoms without concerning features and on the wait list for integrated care clinic at the Princess Alexandra Hospital. Approximately 200 patients will initially receive standardised assessment of symptoms and wheat intolerance. Those patients that 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) an integrated care clinic conditional on their response to the initial intervention. Specific aims of the study include Aim 1: Determine efficacy (symptom improvement) and cost-effectiveness (quality adjusted life years) of a structured, digital technology enabled approach for the management of patients with severe functional gastrointestinal disorders as compared to established service models; Aim 2: Identify response-predictors for the pre-clinical dietary intervention, internet delivered cognitive behavior therapy, exercise physiology and the various clinical interventions; Aim 3: Define acceptance of consumers and staff for the new service model relative to established models of care and Aim 4. To determine the dietary patterns of people with functional gastrointestinal disorders who are presenting with symptoms necessary to access tertiary care and to further examine changes in diet after a range of interventions delivered by telehealth.

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

a) consultant-led outpatient clinic or b) a integrated care clinic

Intervention Type: BEHAVIORAL

Consultation intervention consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic

Interventions

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

Intervention Type: 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 Type: BEHAVIORAL

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Alexandra Hospital, Brisbane, Australia

OTHER

Sponsor Role: collaborator

Macquarie University, Australia

OTHER

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerald Holtmann, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Gerald Holtmann, MD, PhD

Role: CONTACT

g.holtmann@uq.edu.au

61 7 3176 7792

Natasha Koloski, PhD

Role: CONTACT

n.koloski@uq.edu.au

0407126897

Facility Contacts

Gerald Holtmann, PhD

Role: primary

g.holtman@uq.edu.au

07 3176 7792

Natasha Koloski, PhD

Role: backup

n.koloski@uq.edu.au

0407126897

Other Identifiers

APP2004495

Identifier Type: -

Identifier Source: org_study_id