RELIEF-pathway in Patients With Upper Abdominal Pain (RELIEF)

September 2, 2026 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective: The main goal is to evaluate the effect of the RELIEF pathway versus usual care on health care utilization in terms of hospital visits and number of interventions.

Study design: A multicenter randomized controlled open-label superiority trial, with two parallel arms, usual care (control arm) versus the RELIEF pathway (intervention arm). Patients will randomly be assigned (1:1) to usual care or the RELIEF pathway with use of stratification for disease severity, age and sex.

Study population: All patients between 18 and 70 years old, with a first referral by their general practitioner (GP) to the Department of Surgery or Gastroenterology with functional dyspepsia (ICPC D87.02), irritable bowel syndrome (ICPC D93) or uncomplicated symptomatic cholecystolithiasis (ICPC D98.03). Patients are not eligible for inclusion if they and/or GP report alarm symptoms, which may be direct or indirect signs of cancer or upper GI tract bleeding: weight loss, persistent vomiting, dysphagia, jaundice, hematemesis, melena, haematochezia, or anaemia. Patients with a first or second-degree relative with a history of upper GI tract malignant neoplasm, patients with a history of complicated cholecystolithiasis (acute cholecystitis, choledocholithiasis, biliary pancreatitis and cholangitis) or a history of or current malignancy (except SCC or BCC of the skin).

Intervention:

Patients in the intervention group (RELIEF-pathway) will receive access to the web-based education tool before visit of the outpatient clinic of Surgery or Gastroenterology.

The personalized web-based education tool contains information on:

  • Information of cause and symptoms of functional dyspepsia, irritable bowel syndrome and uncomplicated symptomatic cholecystolithiasis;
  • Symptom checker based on the ROME III and ROME IV criteria;
  • Red flags symptoms defined as direct or indirect signs of upper GI hemorrhage.
  • Lifestyle adjustments to improve abdominal symptoms and quality of life.
  • Information on effect of upper gastrointestinal endoscopy, colonoscopy and laparoscopic cholecystectomy.

The investigators aim that the patient will complete the web-based education tool before visiting the outpatient clinic of Surgery and Gastroenterology. The web-based education tool is available during 12 months after randomization.

After the web-based education tool is completed we will offer an additional visit at the Prevention and Lifestyle clinic, this is optional and not obligatory.

Control: Patients assigned to the control group will receive the usual care given at participating centers. During the first visit at the surgery or gastroenterology outpatient clinic subjects are seen by a random medical specialist, who will assess history, examine the patient, and review investigations.Diagnostic and treatment decisions will be based on the physician's preference and experience and on the patients' preferred choice of treatment.

Study Type

Interventional

Enrollment (Estimated)

471

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RELIEF pathway
Patients in the intervention group (RELIEF-pathway) will receive access to the web-based education tool before visit of the outpatient clinic of Surgery or Gastroenterology.
Other: RELIEF-pathway

The personalized web-based education tool contains information on:

  • Information of cause and symptoms of functional dyspepsia, irritable bowel syndrome and uncomplicated symptomatic cholecystolithiasis;
  • Symptom checker based on the ROME III and ROME IV criteria;
  • Red flags symptoms defined as direct or indirect signs of upper GI hemorrhage.
  • Lifestyle adjustments to improve abdominal symptoms and quality of life.
  • Information on effect of upper gastrointestinal endoscopy, colonoscopy and laparoscopic cholecystectomy.

After the web-based education tool is completed we will offer an additional visit at the Prevention and Lifestyle clinic, this is optional and not obligatory.
No Intervention: Usual care
Patients assigned to the control group will receive the usual care given at participating centers. During the first visit at the surgery or gastroenterology outpatient clinic subjects are seen by a random medical specialist, who will assess history, examine the patient, and review investigations. Diagnostic and treatment decisions will be based on the physician's preference and experience and on the patients' preferred choice of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint
Time Frame: 12 months
The primary outcome is the proportion of patients who will undergo diagnostic or treatment intervention within 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to diagnosis
Time Frame: 12 months

time to diagnosis in days

minimum value: 3 days, maxium value: 365 days, higher scores mean worse outcome.
12 months
outpatient clinic- or emergency room visits
Time Frame: 12 months

outpatient clinic- or emergency room visits in numbers

minimum value: 0 maximum value: 50 higher scores mean worse outcome
12 months
Pain severity
Time Frame: 12 months

measured with Izbicky pain

izbicky pain score: 0-100 scale, minimum: 0, maximum: 100, higher scores means worse outcome
12 months
Imaging use
Time Frame: 12 months

Numbers of Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)

Minimum: 0, maximum: 50, higher numbers means worse outcome
12 months
Morbidity and complications
Time Frame: 12 months

will be specified by type of morbidity and complication

minimum: 0 maximum: 100 Higher scores mean worse outcome
12 months
Patient-reported outcomes
Time Frame: 12 months

Questionnaire: PAGI-SYM

Patient Assessment of Upper Gastrointestinal Symptom Severity Index

Heartburn / Regurgitation (7 items)Nausea / Vomiting (3 items)Postprandial Fullness / Early Satiety (4 items)Bloating (2 items)Upper Abdominal Pain (2 items)Lower Abdominal Pain (2 items).

Patients rank their symptoms based on a 2-week recall period. Each symptom is rated on a 6-point scale:0 = None / Absent1 = Mild2 = Moderate3 = Severe4 = Very Severe5 = Extremely Severe

A higher score indicates more severe symptoms and a greater physical burden.

If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
12 months
Pain severity
Time Frame: 12 months
VAS (visual analogue score): 0-10, minimum: 0, maximum: 10, higher scores means worse outcome
12 months
Patient-reported outcomes
Time Frame: 12 months

Questionnaire: SHAI

The Short Health Anxiety Inventory (SHAI) is an 18-item self-report questionnaire used to measure the severity of health anxiety and hypochondriasis.

Total scores range from 0 to 54. Higher numerical scores reflect greater levels of preoccupation with health, bodily vigilance, and distress regarding potential illness.
12 months
Patient-reported outcomes
Time Frame: 12 Months

Questionnaire: SDM-Q-9 9-item Shared Decision Making Questionnaire.

A 9-item self-report tool used to measure a patient's perception of shared decision-making during a medical consultation.

Each item is rated on a 6-point scale from 0 ("completely disagree") to 5 ("completely agree").

0 to 100 scale (higher scores mean greater perceived involvement (= better outcome)).
12 Months
Patient-reported outcome measurements
Time Frame: 12 months

The iMTA Medical Consumption Questionnaire (iMCQ) scoring works by multiplying the self-reported frequency of each health care service use by its corresponding standard unit cost price.

Higher score means worse outcome.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Cornelis van Laarhoven, MD PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

April 15, 2026

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-12618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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