Clinical trial NCT05274854: A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
Official title: A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Diseases
Irritable Bowel Syndrome
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Princess Alexandra Hospital, Brisbane, Australia
name: Macquarie University, Australia
First posted: 2022-03-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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. Patients will initially receive standardised assessment of symptoms and wheat intolerance. Those patients that continue to experience symptoms will then be randomised to one of four pre-consultation interventions followed by randomisation to one of two consultation interventions conditional on their response to the initial intervention.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 0
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 8
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 16
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 20
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 24
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 28
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 32
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 35
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 38
measure: Structured Assessment of Gastrointestinal Symptoms score
timeFrame: Week 44
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 0
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 8
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 16
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 20
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 24
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 28
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 32
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 35
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 38
measure: European Quality of Life Five Dimension (EQ-5D)
timeFrame: Week 44
measure: Cost effectiveness
timeFrame: Week 0
measure: Cost effectiveness
timeFrame: Week 8
measure: Cost effectiveness
timeFrame: Week 16
measure: Cost effectiveness
timeFrame: Week 28
measure: Cost effectiveness
timeFrame: Week 44
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Week 0
measure: Hospital Anxiety and Depression Scale
timeFrame: Week 16
measure: Hospital Anxiety and Depression Scale
timeFrame: Week 28
measure: Hospital Anxiety and Depression Scale
timeFrame: Week 44
measure: Microbiome
timeFrame: Week 0
measure: Microbiome
timeFrame: Week 16
measure: Microbiome
timeFrame: Week 28
measure: Microbiome
timeFrame: Week 44
measure: Acceptance of models of care by consumers and staff
timeFrame: Week 16
measure: Acceptance of models of care by consumers and staff
timeFrame: Week 28
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Gerald Holtmann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: