Actively Recruiting
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness
Led by The University of Queensland · Updated on 2024-11-12
200
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
T
The University of Queensland
Lead Sponsor
P
Princess Alexandra Hospital, Brisbane, Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and cost-efficiency of early remote interventions for patients with severe, chronic, or relapsing gastrointestinal symptoms that lack clear explanation and who are waiting for care in an integrated clinic. The study uses a two-stage randomization to compare different approaches, aiming to improve symptom management, identify which patients respond best to certain treatments, and assess acceptance of new care models. About 200 patients will initially have their symptoms and wheat intolerance assessed remotely. Participants who continue to experience symptoms after initial assessment will be randomly assigned to one of four pre-consultation interventions: a standardized dietician-supervised program, an exercise program, internet-delivered cognitive behavior therapy, or no intervention. Following this, they will be randomized again to receive either a consultant-led outpatient clinic consultation or care in an integrated clinic, depending on their response to the pre-consultation intervention. Throughout the study, participants will be regularly assessed using a structured gastrointestinal symptoms score and quality of life measures, collected at multiple time points up to 44 weeks. Additional evaluations include anxiety and depression scales, microbiome analysis, and acceptance of care models by patients and staff. Cost-effectiveness will also be tracked. The total participation involves remote interventions, clinical consultations, and multiple assessments over time to monitor symptoms, quality of life, and treatment impact.
CONDITIONS
Brief Title
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relevant, chronic, or relapsing gastrointestinal symptoms without concerning features and on the wait list for integrated care clinic
- 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
You will not qualify if you...
- Patients with alarm signs or symptoms such as significant unexplained weight loss, gastrointestinal bleeding, iron deficiency anaemia, or new onset GI symptoms requiring urgent clinical work-up
- Patients with mild or moderate symptoms unlikely to require clinical work-up or expected to improve spontaneously
- Patients with comorbidities interfering with study interventions
- Patients with prior history of eating disorders, wait listed for bariatric surgery, or those who have had bariatric surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive one of four pre-consultation behavioral interventions: a standardised dietician supervised intervention, exercise intervention, internet delivered cognitive behavior therapy, or no intervention.
Visits according to assigned intervention schedule
Duration - Up to 36 weeks
Participants undergo a consultation intervention consisting of either a consultant-led outpatient clinic or an integrated care clinic, depending on their response to the preconsultation intervention.
Multiple visits as part of outpatient or integrated care clinic
Duration - Up to 44 weeks
Participants are monitored for symptom improvement and quality of life through structured assessments and questionnaires over the study period.
Scheduled assessments at multiple time points up to Week 44
Trial Site Locations
Total: 1 location
1
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
Research Team
G
Gerald Holtmann, MD, PhD
N
Natasha Koloski, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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