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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05274854
Registration number
NCT05274854
Ethics application status
Date submitted
7/02/2022
Date registered
11/03/2022
Date last updated
28/06/2023
Titles & IDs
Public title
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
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Scientific title
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness
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Secondary ID [1]
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APP2004495
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Diseases
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Irritable Bowel Syndrome
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing
Behaviour - a) consultant-led outpatient clinic or b) a integrated care clinic
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)
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.
Behaviour: 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
Behaviour: 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
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [1]
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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
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Timepoint [1]
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Week 0
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Primary outcome [2]
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Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [2]
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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
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Timepoint [2]
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Week 8
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Primary outcome [3]
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Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [3]
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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
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Timepoint [3]
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Week 16
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Primary outcome [4]
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Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [4]
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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
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Timepoint [4]
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Week 20
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Primary outcome [5]
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Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [5]
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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
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Timepoint [5]
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Week 24
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Primary outcome [6]
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Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [6]
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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
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Timepoint [6]
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Week 28
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Primary outcome [7]
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Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [7]
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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
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Timepoint [7]
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Week 32
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Primary outcome [8]
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Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [8]
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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
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Timepoint [8]
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0
Week 35
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Primary outcome [9]
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Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [9]
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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
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Timepoint [9]
0
0
Week 38
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Primary outcome [10]
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0
Structured Assessment of Gastrointestinal Symptoms score
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Assessment method [10]
0
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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
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Timepoint [10]
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Week 44
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Primary outcome [11]
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European Quality of Life Five Dimension (EQ-5D)
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Assessment method [11]
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The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [11]
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Week 0
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Primary outcome [12]
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European Quality of Life Five Dimension (EQ-5D)
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Assessment method [12]
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The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [12]
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Week 8
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Primary outcome [13]
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European Quality of Life Five Dimension (EQ-5D)
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Assessment method [13]
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The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [13]
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Week 16
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Primary outcome [14]
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European Quality of Life Five Dimension (EQ-5D)
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Assessment method [14]
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The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [14]
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Week 20
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Primary outcome [15]
0
0
European Quality of Life Five Dimension (EQ-5D)
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Assessment method [15]
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The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [15]
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Week 24
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Primary outcome [16]
0
0
European Quality of Life Five Dimension (EQ-5D)
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Assessment method [16]
0
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The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [16]
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Week 28
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Primary outcome [17]
0
0
European Quality of Life Five Dimension (EQ-5D)
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Assessment method [17]
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The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [17]
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Week 32
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Primary outcome [18]
0
0
European Quality of Life Five Dimension (EQ-5D)
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Assessment method [18]
0
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The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [18]
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Week 35
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Primary outcome [19]
0
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European Quality of Life Five Dimension (EQ-5D)
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Assessment method [19]
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The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [19]
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Week 38
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Primary outcome [20]
0
0
European Quality of Life Five Dimension (EQ-5D)
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Assessment method [20]
0
0
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
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Timepoint [20]
0
0
Week 44
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Primary outcome [21]
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Cost effectiveness
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Assessment method [21]
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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)
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Timepoint [21]
0
0
Week 0
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Primary outcome [22]
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Cost effectiveness
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Assessment method [22]
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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)
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Timepoint [22]
0
0
Week 8
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Primary outcome [23]
0
0
Cost effectiveness
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Assessment method [23]
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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)
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Timepoint [23]
0
0
Week 16
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Primary outcome [24]
0
0
Cost effectiveness
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Assessment method [24]
0
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)
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Timepoint [24]
0
0
Week 28
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Primary outcome [25]
0
0
Cost effectiveness
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Assessment method [25]
0
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)
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Timepoint [25]
0
0
Week 44
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Secondary outcome [1]
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Hospital Anxiety and Depression Scale
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Assessment method [1]
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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.
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Timepoint [1]
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Week 0
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Secondary outcome [2]
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Hospital Anxiety and Depression Scale
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Assessment method [2]
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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.
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Timepoint [2]
0
0
Week 16
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Secondary outcome [3]
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0
Hospital Anxiety and Depression Scale
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Assessment method [3]
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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.
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Timepoint [3]
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Week 28
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Secondary outcome [4]
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0
Hospital Anxiety and Depression Scale
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Assessment method [4]
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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.
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Timepoint [4]
0
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Week 44
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Secondary outcome [5]
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Microbiome
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Assessment method [5]
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Total abundance and relative abundance of specific phyla of the microbiome
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Timepoint [5]
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Week 0
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Secondary outcome [6]
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Microbiome
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Assessment method [6]
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Total abundance and relative abundance of specific phyla of the microbiome
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Microbiome
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Assessment method [7]
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Total abundance and relative abundance of specific phyla of the microbiome
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Timepoint [7]
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Week 28
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Secondary outcome [8]
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Microbiome
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Assessment method [8]
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Total abundance and relative abundance of specific phyla of the microbiome
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Timepoint [8]
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Week 44
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Secondary outcome [9]
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Acceptance of models of care by consumers and staff
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Assessment method [9]
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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..'
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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Acceptance of models of care by consumers and staff
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Assessment method [10]
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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..'
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Timepoint [10]
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Week 28
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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0
Other
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Name [1]
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0
Princess Alexandra Hospital, Brisbane, Australia
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Address [1]
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0
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Country [1]
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0
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Other collaborator category [2]
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0
Other
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Name [2]
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Macquarie University, Australia
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Address [2]
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0
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Country [2]
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0
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05274854
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gerald Holtmann, MD PhD
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Address
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The University of Queensland
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Country
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0
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Phone
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Fax
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0
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Email
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Contact person for public queries
Name
0
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Gerald Holtmann, MD, PhD
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Address
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Country
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Phone
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61 7 3176 7792
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05274854
Download to PDF