An interventional study of a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing and a) consultant-led outpatient clinic or b) a integrated care clinic in Gastrointestinal Diseases and Irritable Bowel Syndrome, sponsored by The University of Queensland. Status unknown at 1 site in Australia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by The University of Queensland · Not applicable, Interventional, and Treatment
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.
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.
639 studies on the registry are indexed under Gastrointestinal Diseases; 126 are open to participants now.
This study's planned enrollment of 200 is above the median of 77 across 428 interventional studies indexed under Gastrointestinal Diseases.
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Exclusion Criteria:
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
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
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 consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic
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
Time frame: Week 0
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
Time frame: Week 8
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
Time frame: Week 16
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
Time frame: Week 20
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
Time frame: Week 24
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
Time frame: Week 28
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
Time frame: Week 32
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
Time frame: Week 35
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
Time frame: Week 38
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
Time frame: Week 44
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
Time frame: Week 0
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
Time frame: Week 8
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
Time frame: Week 16
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
Time frame: Week 20
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
Time frame: Week 24
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
Time frame: Week 28
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
Time frame: Week 32
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
Time frame: Week 35
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
Time frame: Week 38
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
Time frame: Week 44
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)
Time frame: Week 0
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)
Time frame: Week 8
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)
Time frame: Week 16
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)
Time frame: Week 28
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)
Time frame: Week 44
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.
Time frame: Week 0
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.
Time frame: Week 16
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.
Time frame: Week 28
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.
Time frame: Week 44
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Time frame: Week 0
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Time frame: Week 16
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Time frame: Week 28
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Time frame: Week 44
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..'
Time frame: Week 16
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..'
Time frame: Week 28
Plan to share: No — Deidentified group data will be analysed and published in medical journals
No publications or documents are linked to this record.
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The University of Queensland