NCT06002516: RELIEF

RELIEF-pathway in Patients With Upper Abdominal Pain

Not yet recruiting NA Last updated 21 August 2023

What this trial tests

NA trial testing RELIEF-pathway in Abdominal Pain in 471 participants. Not yet recruiting.

Timeline

1 May 2024

Primary endpoint
1 May 2026

1 May 2027

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	471
Start date	1 May 2024
Primary completion	1 May 2026
Estimated completion	1 May 2027

Drugs / interventions tested

• RELIEF-pathway

Conditions studied

• Abdominal Pain — all drugs for Abdominal Pain →
• Gallstone; Colic — all drugs for Gallstone; Colic →
• Dyspepsia — all drugs for Dyspepsia →
• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Radboud University Medical Center

Who can join

Adults 18 to 70, any sex, with Abdominal Pain or Gallstone; Colic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.