The RELIEF-trial for patients with upper abdominal pain: study protocol for a randomized controlled trial to investigate the effectiveness of a web-based self-management tool compared with usual care for reduction of healthcare utilization and improvement of patient-reported outcomes
NCT ID NCT06002516
First seen Sep 09, 2026 ยท Last updated Sep 09, 2026
Summary
Upper abdominal pain (UAP) is a common symptom and frequently the reason to visit the hospital. The prevalence of epigastric pain in the Dutch population is estimated to be as high as 37%. Moreover, Dutch hospitals yearly record \>100.000 diagnoses related to UAP. In most patients, UAP can be attributed to symptomatic (functional) dyspepsia (FD), Irritable Bowel Syndrome (IBS) or uncomplicated gallstone disease (cholecystolithiasis), with a prevalence in the general population of 20-30%, 20%, and 6-9%, respectively. However, these conditions may have overlapping symptom patterns and generally affect similar populations. which contributes to ineffective (diagnostic) interventions. Patients are generally not aware of the similarity of symptoms and the poor outcome of some treatments. Education positively influences patients' self-management and health judgment. In a recent open-label, multicentre trial the effectiveness of web-based patients' education is applied to reduce overuse of upper gastrointestinal endoscopies in patients with dyspepsia. This study illustrated that an web-based education tool safely reduced 40% in upper gastrointestinal endoscopies. Lifestyle interventions (such as change of diet and/or physical activity) are widely incorporated in treatment programs for cardio-vascular diseases including diabetes mellitus and obesity. An web-based education tool on upper abdominal pain and other complaints combined with a lifestyle interventions for patients may be an effective treatment option for this large group of patients. This study investigates the potential of an individualized web-based education tool as intervention for patients with functional dyspepsia, irritable bowel syndrome and uncomplicated symptomatic cholecystolithiasis with the possibility to visit the Prevention and Lifestyle clinic (RELIEF pathway). The RELIEF pathway aims to reduce unnecessary health care utilization and, secondly, to maintain and improve quality of life by educating patients on lifestyle improvement.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 471 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients between 18 and 70 years old. * First referral due to upper abdominal pain (UAP) and symptoms due to Functional dyspepsia (ICPC code 87.02), Irritable Bowel syndrome (ICPC 93.0) or uncomplicated symptomatic cholecystolithiasis (ICPC 98.03). * Proficient in reading and understanding of the Dutch language. * Referred to the outpatient clinic of gastroenterology or surgery. * Providing informed consent. Exclusion Criteria: * Unexplained weight loss * Persistent vomiting * Gastrointestinal bleeding * Any other direct or indirect signs of cancer or upper GI tract bleeding * Anemia * Jaundice * Pregnancy * An expected life span of less than 12 months * Known liver diseases * A history of complicated cholecystolithiasis * A history of inflammatory bowel disease * A history of malignancy, except squamous cell carcinoma (SCC)/basal cell -carcinoma (BCC) * First or second degree relative with history of upper GI malignancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA, Netherlands
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