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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05274854
• Other study ID #: APP2004495
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: The University of Queensland
• Contact: Gerald Holtmann, MD, PhD
• Phone: 61 7 3176 7792
• Email: g.holtmann[@]uq.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Irritable Bowel Syndrome

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
The University of Queensland	Macquarie University, Australia, Princess Alexandra Hospital, Brisbane, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 0
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 8
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 16
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 20
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 24
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 28
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 32
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 35
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 38
Primary	Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 44
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 0
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 8
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 16
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 20
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 24
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 28
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 32
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 35
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 38
Primary	European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 44
Primary	Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 0
Primary	Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 8
Primary	Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 16
Primary	Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 28
Primary	Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 44
Secondary	Hospital Anxiety and Depression Scale	Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.	Week 0
Secondary	Hospital Anxiety and Depression Scale	Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.	Week 16
Secondary	Hospital Anxiety and Depression Scale	Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.	Week 28
Secondary	Hospital Anxiety and Depression Scale	Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.	Week 44
Secondary	Microbiome	Total abundance and relative abundance of specific phyla of the microbiome	Week 0
Secondary	Microbiome	Total abundance and relative abundance of specific phyla of the microbiome	Week 16
Secondary	Microbiome	Total abundance and relative abundance of specific phyla of the microbiome	Week 28
Secondary	Microbiome	Total abundance and relative abundance of specific phyla of the microbiome	Week 44
Secondary	Acceptance of models of care by consumers and staff	For the pre-consultation and the 3- months intervention period, the consumer's net promotor score ('…I would recommend the service I received to a family member or friend yes/no..') will be determined and compared. With regard to the team providing services to the patients, all members providing care will respond to the following question in relation to specific treatment groups: '...I have been able to address the patient's problems yes/no..'	Week 16
Secondary	Acceptance of models of care by consumers and staff	For the pre-consultation and the 3- months intervention period, the consumer's net promotor score ('…I would recommend the service I received to a family member or friend yes/no..') will be determined and compared. With regard to the team providing services to the patients, all members providing care will respond to the following question in relation to specific treatment groups: '...I have been able to address the patient's problems yes/no..'	Week 28