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ESM in Functional Dyspepsia (MEASuRE-D)

Primary Purpose

Dyspepsia, Dyspepsia and Other Specified Disorders of Function of Stomach

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Experience Sampling Method (ESM)
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyspepsia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Both patients with functional dyspepsia (36) as healthy controls (36) will be included

Inclusion Criteria for patients with functional dyspepsia:

• A diagnosis of functional dyspepsia according to ROME IV criteria (2):

  • One or more of the following:
  • Bothersome postprandial fullness
  • Bothersome early satiation
  • Bothersome epigastric pain
  • Bothersome epigastric burning

AND

  • No evidence of structural disease (confirmed by upper endoscopy) that is likely to explain the symptoms.
  • Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.

    • Age between 18 and 75 years;
    • Ability to understand and speak the Dutch language;
    • Ability to understand how to utilize the ESM tool.

Inclusion criteria for healthy volunteers:

  • Age between 18 and 75 years
  • Ability to understand and speak the Dutch language
  • Ability to understand how to utilize the ESM tool.

Exclusion Criteria for patients with functional dyspepsia:

  • Any organic explanation for the gastrointestinal complaints;
  • Initiation of regularly used medication from one month before inclusion until the end of study participation;
  • A history of upper digestive surgery influencing end points
  • A history of radiation therapy of the abdomen
  • Pregnancy

Exclusion Criteria for healthy controls:

  • Current diagnosis of any gastrointestinal disorder
  • Current gastrointestinal symptoms suiting the ROME IV criteria for FD
  • Initiation of regularly used medication from one month before inclusion until the end of study participation
  • Pregnancy

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experience Sampling Method (ESM)

Arm Description

Both patients with functional dyspepsia and healthy controls will be asked to fill out ESM questionnaires during 1 week. Moreover, at the end of this week, usual questionnaires for complaints assessment will be filled out.

Outcomes

Primary Outcome Measures

Change in experience sampling method (ESM) scores
Using the MEASuRE-D app, the same ESM questionnaire will be filled in 10 times per day at random intervals. This results in a lot of real-time data on patient symptom scores on which changes over the course of the day can be seen.
Patient complaint diary
Using the MEASuRE-D app, patients will fill out a complaints diary at the end of each day during 7 days

Secondary Outcome Measures

Questionnaire for demographic characteristics
A questionnaire for demographic characteristics will be filled in by participants.
PAGI-SYM questionnaire
the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity index (PAGI-SYM) questionnaire will be filled in by participants. Questions about upper gastrointestinal symptoms are asked on a 6 point likert scale with 0 indicating not at all and 5 indicating very severe.
NDI questionnaire
The Nepean Dyspepsia Index (NDI) questionnaire will be filled in by participants. The NDI questionaire consists of various questions. Questions about the effects of upper gastrointestinal symptoms are asked on a 5 point likert scale with 1 indicating not at all/almost never and 5 indicating very severe/always.
GSRS questionnaire
The Gastrointestinal Symptom Rating Scale (GSRS) will be filled in by participants. Questions about gastrointestinal symptoms are asked on a 7 point likert scale with 0 indicating not at all and 6 indicating very severe.
PHQ-9 questionnaire
The Patient Health Questionnaire-9 (PHQ-9) will be filled in by participants. Questions about the severity of depressive symptoms are asked on a scale from 0 - 3, where 0 indicates not at all, 1 indicates some days, 2 indicates more than half of the days, and 3 indicates almost every day.
GAD-7 questionnaire
The Generalized Anxiety Disorder-7 (GAD-7) questionnaire will be filled in by participants. Questions about the severity of anxiety symptoms are asked on a scale from 0 - 3, where 0 indicates not at all, 1 indicates some days, 2 indicates more than half of the days, and 3 indicates almost every day.
PHQ-15 questionnaire
The Patient Health Questionnaire-15 (PHQ-15) will be filled in by participants. Questions about somatization symptoms are asked in the following matter: how often have you been bothered by "..." on a scale from 0 - 2, where 0 indicates not at all, 1 indicates bothered a little, and 2 indicates bothered a lot.
SF-36 questionnaire
The Short Form-36 (SF-36) questionnaire will be filled in by participants and consits of various types of questions. Some questions about how their health limits them in certain daily activities are asked on a scale of 1-3, with 1 indicating limits severely, 2 indicating limits a little, and 3 indicating not limited at all Some questions about problems in participants' work or daily activities due to physical health, emotional problems are dichotomous with 1 indicating yes and 2 indicating no Some questions about how participants felt themselves during a period are asked on a 6 point scale with 1 indicating all the time, 2 indicating most of the time, 3 indicating often, 4 indicating sometimes, 5 indicating occasionally, and 6 indicating not at all Participants need to indicate how much a few statements apply to them with 1 indicating completely correct, 2 indicating mostly correct, 3 indicating I don't know, 4 indicating mostly incorrect, and 5 indicating completely correct

Full Information

First Posted
December 9, 2019
Last Updated
October 6, 2020
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04204421
Brief Title
ESM in Functional Dyspepsia
Acronym
MEASuRE-D
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Dyspepsia and Other Specified Disorders of Function of Stomach

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experience Sampling Method (ESM)
Arm Type
Experimental
Arm Description
Both patients with functional dyspepsia and healthy controls will be asked to fill out ESM questionnaires during 1 week. Moreover, at the end of this week, usual questionnaires for complaints assessment will be filled out.
Intervention Type
Other
Intervention Name(s)
Experience Sampling Method (ESM)
Other Intervention Name(s)
ESM
Intervention Description
Experience Sampling Method (ESM) is a method for real time complaints assessment where people are asked to fill out a questionnaire 10 times per day at random moments. This will be done via a mobile phone application.
Primary Outcome Measure Information:
Title
Change in experience sampling method (ESM) scores
Description
Using the MEASuRE-D app, the same ESM questionnaire will be filled in 10 times per day at random intervals. This results in a lot of real-time data on patient symptom scores on which changes over the course of the day can be seen.
Time Frame
10 times daily, during 1 week
Title
Patient complaint diary
Description
Using the MEASuRE-D app, patients will fill out a complaints diary at the end of each day during 7 days
Time Frame
End of day 1, end of day 2, end of day 3, end of day 4, end of day 5, end of day 6, end of day 7
Secondary Outcome Measure Information:
Title
Questionnaire for demographic characteristics
Description
A questionnaire for demographic characteristics will be filled in by participants.
Time Frame
On day 7
Title
PAGI-SYM questionnaire
Description
the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity index (PAGI-SYM) questionnaire will be filled in by participants. Questions about upper gastrointestinal symptoms are asked on a 6 point likert scale with 0 indicating not at all and 5 indicating very severe.
Time Frame
On day 7
Title
NDI questionnaire
Description
The Nepean Dyspepsia Index (NDI) questionnaire will be filled in by participants. The NDI questionaire consists of various questions. Questions about the effects of upper gastrointestinal symptoms are asked on a 5 point likert scale with 1 indicating not at all/almost never and 5 indicating very severe/always.
Time Frame
On day 7
Title
GSRS questionnaire
Description
The Gastrointestinal Symptom Rating Scale (GSRS) will be filled in by participants. Questions about gastrointestinal symptoms are asked on a 7 point likert scale with 0 indicating not at all and 6 indicating very severe.
Time Frame
On day 7
Title
PHQ-9 questionnaire
Description
The Patient Health Questionnaire-9 (PHQ-9) will be filled in by participants. Questions about the severity of depressive symptoms are asked on a scale from 0 - 3, where 0 indicates not at all, 1 indicates some days, 2 indicates more than half of the days, and 3 indicates almost every day.
Time Frame
On day 7
Title
GAD-7 questionnaire
Description
The Generalized Anxiety Disorder-7 (GAD-7) questionnaire will be filled in by participants. Questions about the severity of anxiety symptoms are asked on a scale from 0 - 3, where 0 indicates not at all, 1 indicates some days, 2 indicates more than half of the days, and 3 indicates almost every day.
Time Frame
On day 7
Title
PHQ-15 questionnaire
Description
The Patient Health Questionnaire-15 (PHQ-15) will be filled in by participants. Questions about somatization symptoms are asked in the following matter: how often have you been bothered by "..." on a scale from 0 - 2, where 0 indicates not at all, 1 indicates bothered a little, and 2 indicates bothered a lot.
Time Frame
On day 7
Title
SF-36 questionnaire
Description
The Short Form-36 (SF-36) questionnaire will be filled in by participants and consits of various types of questions. Some questions about how their health limits them in certain daily activities are asked on a scale of 1-3, with 1 indicating limits severely, 2 indicating limits a little, and 3 indicating not limited at all Some questions about problems in participants' work or daily activities due to physical health, emotional problems are dichotomous with 1 indicating yes and 2 indicating no Some questions about how participants felt themselves during a period are asked on a 6 point scale with 1 indicating all the time, 2 indicating most of the time, 3 indicating often, 4 indicating sometimes, 5 indicating occasionally, and 6 indicating not at all Participants need to indicate how much a few statements apply to them with 1 indicating completely correct, 2 indicating mostly correct, 3 indicating I don't know, 4 indicating mostly incorrect, and 5 indicating completely correct
Time Frame
On day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Both patients with functional dyspepsia (36) as healthy controls (36) will be included Inclusion Criteria for patients with functional dyspepsia: • A diagnosis of functional dyspepsia according to ROME IV criteria (2): One or more of the following: Bothersome postprandial fullness Bothersome early satiation Bothersome epigastric pain Bothersome epigastric burning AND No evidence of structural disease (confirmed by upper endoscopy) that is likely to explain the symptoms. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis. Age between 18 and 75 years; Ability to understand and speak the Dutch language; Ability to understand how to utilize the ESM tool. Inclusion criteria for healthy volunteers: Age between 18 and 75 years Ability to understand and speak the Dutch language Ability to understand how to utilize the ESM tool. Exclusion Criteria for patients with functional dyspepsia: Any organic explanation for the gastrointestinal complaints; Initiation of regularly used medication from one month before inclusion until the end of study participation; A history of upper digestive surgery influencing end points A history of radiation therapy of the abdomen Pregnancy Exclusion Criteria for healthy controls: Current diagnosis of any gastrointestinal disorder Current gastrointestinal symptoms suiting the ROME IV criteria for FD Initiation of regularly used medication from one month before inclusion until the end of study participation Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Masclee, Prof.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34524263
Citation
Klaassen T, Vork L, Smeets FGM, Troost FJ, Kruimel JW, Leue C, Masclee AAM, Keszthelyi D. The Interplay Between Stress and Fullness in Patients With Functional Dyspepsia and Healthy Controls: An Exploratory Experience Sampling Method Study. Psychosom Med. 2022 Apr 1;84(3):306-312. doi: 10.1097/PSY.0000000000001012.
Results Reference
derived

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ESM in Functional Dyspepsia

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