Clinical Trials Logo
  1. Home
  2. Dyspepsia
  3. NCT04204421

ESM in Functional Dyspepsia — MEASuRE-D  

Dyspepsia Clinical Trial

Official title:
The Experience Sampling Method (ESM): Validation of a Newly Developed Real-time Patient-Reported Outcome Measure (PROM) and Its Evaluation of Triggers for Functional Dyspepsia

Clinical Trial Summary

Background:

Reliable patient reported outcome measures (PROM's) for symptom assessment in functional dyspepsia (FD) are essential in order to evaluate dyspeptic symptoms, identify potential symptom triggers and optimize therapeutic strategies, since biological markers are unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an electronic questioning method characterized by random and repeated, momentary assessments in the subject's current state and environment, might overcome these limitations. The aim of this study is to assess the validity and reliability of an FD-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and identification of symptom triggers in patients with functional dyspepsia.

Objective:

The aim of this study is to assess the validity and reliability of an FD-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and identification of symptom triggers in patients with functional dyspepsia. In order to measure this, internal consistency, test-retest reliability, concurrent validity and the accuracy to differentiate between dyspeptic patients and healthy controls of the developed ePRO will be assessed. In addition, to objectify specific triggers for the onset of gastrointestinal symptoms in dyspepsia, using the FD-specific ESM tool.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Dyspepsia
  • Dyspepsia and Other Specified Disorders of Function of Stomach
Clinical Trial Details
NCT number NCT04204421
Study type Interventional
Source Maastricht University Medical Center
Contact
Status Completed
Phase N/A
Start date May 29, 2020
Completion date October 1, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06094062 - Smartphone App-assisted PPI N/A
Completed NCT03941288 - Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia Phase 2
Completed NCT04429802 - The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Withdrawn NCT02863822 - Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia. N/A
Recruiting NCT00978159 - Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia Phase 4
Completed NCT00723502 - Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients Phase 2
Completed NCT00148603 - Montelukast in the Treatment of Duodenal Eosinophilia N/A
Completed NCT00217347 - Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy N/A
Terminated NCT00220844 - Tricyclic Antidepressants (TCAs) on Gastric Emptying N/A
Completed NCT00110968 - Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia Phase 3
Completed NCT00232037 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Completed NCT00164996 - Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia Phase 3
Completed NCT00232102 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Recruiting NCT05718960 - Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia N/A
Completed NCT05750641 - The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
Terminated NCT04247100 - A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders N/A
Completed NCT03252743 - ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study. N/A
Completed NCT04697641 - Helicobacter Pylori Eradication in Functional Dyspepsia N/A
Recruiting NCT04918329 - Functional Digestive Disorders Observatory