DyspepsiaMEASuRE-DNCT04204421
ESM in Functional Dyspepsia
A study testing Experience Sampling Method (ESM) in people with Dyspepsia and Dyspepsia and Other Specified Disorders of Function of Stomach, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia, Dyspepsia and Other Specified Disorders of Function of Stomach
- What is being tested?
- Experience Sampling Method (ESM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 May 2020to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Age between 18 and 75 years
- Ability to understand and speak the Dutch language
- Ability to understand how to utilize the ESM tool.
Who cannot join
- 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
- Current diagnosis of any gastrointestinal disorder
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
About this study
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
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.
Read more
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.
- Being tested
- Experience Sampling Method (ESM)
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experience Sampling Method (ESM)Other
Also called ESM
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.
| Study group | Role | What they receive |
|---|---|---|
| Experience Sampling Method (ESM) | Experimental | 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. Receives: Other: Experience Sampling Method (ESM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 times daily, during 1 week
Patient complaint diary
Using the MEASuRE-D app, patients will fill out a complaints diary at the end of each day during 7 days
Measured: 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 outcomes (8)
Questionnaire for demographic characteristics
A questionnaire for demographic characteristics will be filled in by participants.
Measured: On day 7
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.
Measured: On day 7
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.
Measured: On day 7
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.
Measured: On day 7
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.
Measured: On day 7
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.
Measured: On day 7
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.
Measured: On day 7
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
Measured: On day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start29 May 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Masclee, Prof., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204421
- Sponsor's protocol ID
- METC 19-077 / NL71810.068.19
- Acronym
- MEASuRE-D
- Status last verified
- Oct 2020
- First submitted
- 9 Dec 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34524263
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04204421
- Acronym / sponsor ID
- MEASuRE-D / METC 19-077 / NL71810.068.19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experience Sampling Method (ESM) | Experimental | Other: Experience Sampling Method (ESM)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experience Sampling Method (ESM)Also: ESMExperience 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. | Other | Experience Sampling Method (ESM) |
Primary outcome
Change in experience sampling method (ESM) scores
Time frame: 10 times daily, during 1 week
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
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
Using the MEASuRE-D app, patients will fill out a complaints diary at the end of each day during 7 days
8 secondary outcomes
Questionnaire for demographic characteristics
Time frame: On day 7
PAGI-SYM questionnaire
Time frame: On day 7
NDI questionnaire
Time frame: On day 7
GSRS questionnaire
Time frame: On day 7
PHQ-9 questionnaire
Time frame: On day 7
GAD-7 questionnaire
Time frame: On day 7
PHQ-15 questionnaire
Time frame: On day 7
SF-36 questionnaire
Time frame: On day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34524263Klaassen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Masclee, Prof. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experience Sampling Method (ESM) in people with Dyspepsia and Dyspepsia and Other Specified Disorders of Function of Stomach, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in experience sampling method (ESM) scores (time frame: 10 times daily, during 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04204421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.