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

November 10, 2024 updated by: The University of Queensland

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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)
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
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 0
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
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 8
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
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 16
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
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 20
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
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 24
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
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 28
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
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 32
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
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 35
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
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 38
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
Structured Assessment of Gastrointestinal Symptoms score
Time Frame: Week 44
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 0
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 8
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 16
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 20
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 24
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 28
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 32
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 35
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 38
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
European Quality of Life Five Dimension (EQ-5D)
Time Frame: Week 44
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
Cost effectiveness
Time Frame: Week 0
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
Cost effectiveness
Time Frame: Week 8
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
Cost effectiveness
Time Frame: Week 16
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
Cost effectiveness
Time Frame: Week 28
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
Cost effectiveness
Time Frame: Week 44
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale
Time Frame: Week 0
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
Hospital Anxiety and Depression Scale
Time Frame: Week 16
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
Hospital Anxiety and Depression Scale
Time Frame: Week 28
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
Hospital Anxiety and Depression Scale
Time Frame: Week 44
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
Microbiome
Time Frame: Week 0
Total abundance and relative abundance of specific phyla of the microbiome
Week 0
Microbiome
Time Frame: Week 16
Total abundance and relative abundance of specific phyla of the microbiome
Week 16
Microbiome
Time Frame: Week 28
Total abundance and relative abundance of specific phyla of the microbiome
Week 28
Microbiome
Time Frame: Week 44
Total abundance and relative abundance of specific phyla of the microbiome
Week 44
Acceptance of models of care by consumers and staff
Time Frame: Week 16
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
Acceptance of models of care by consumers and staff
Time Frame: Week 28
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Queensland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Princess Alexandra Hospital, Brisbane, Australia
Macquarie University, Australia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gerald Holtmann, MD PhD, The University of Queensland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APP2004495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified group data will be analysed and published in medical journals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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