Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05274854

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gastrointestinal Diseases Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Microbiome

    Time frame: Week 0

    Total abundance and relative abundance of specific phyla of the microbiome

  6. Microbiome

    Time frame: Week 16

    Total abundance and relative abundance of specific phyla of the microbiome

  7. Microbiome

    Time frame: Week 28

    Total abundance and relative abundance of specific phyla of the microbiome

  8. Microbiome

    Time frame: Week 44

    Total abundance and relative abundance of specific phyla of the microbiome

  9. 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..'

  10. 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..'

Study contacts

Contact information is provided by the study sponsor or research team.

Gerald Holtmann, MD, PhD

CONTACT

[email protected]

61 7 3176 7792

Natasha Koloski, PhD

CONTACT

[email protected]

0407126897

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

  • Macquarie University, Australia
  • Princess Alexandra Hospital, Brisbane, Australia

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2022
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.