Irritable Bowel SyndromeNCT02880722
Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel syndrome are essential in order to investigate natural disease course and potential treatment options aimed at symptom improvement, since biological markers are currently unavailable. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 184 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2016to 1 May 2022
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: IBS patients.
Who may be able to join
- Diagnosis of irritable bowel syndrome according to Rome IV criteria.
- Ability to understand and speak the national language of the concerning center.
- Ability to understand how to utilize the ESM-tool.
Who cannot join
- Any organic explanation for the abdominal complaints.
- A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy.
- Start up of regularly used medication from one month before inclusion until the end of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Real-time Patient-Reported Outcome Measure for Chronic Abdominal Pain: The Experience Sampling Method (ESM)
Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel syndrome are essential in order to investigate natural disease course and potential treatment options aimed at symptom improvement, since biological markers are currently 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. Aim of this study is to validate an IBS-specific electronic patient-reported outcome measure, based on the Experience Sampling Method-principle, for symptom assessment in IBS.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome (IBS), Experience Sampling Method (ESM), Ecological Momentary Assessment (EMA), Abdominal pain
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBS patients | IBS according to Rome IV criteria. | |
| Healthy control group | Healthy volunteers without abdominal complaints fulfilling Rome IV criteria for IBS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain scores as measured by the ESM tool.
Momentary measurements.
Measured: 7 days
Secondary outcomes (8)
Abdominal pain scores as measured by the end-of-day diary.
Retrospective measurements with a recall period of one day.
Measured: 7 days
Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.
Retrospective measurements with a recall period of one week.
Measured: 7 days
Symptom scores (other than abdominal pain) as measured using the ESM-tool.
Gastrointestinal symptoms, psychological symptoms, extra-intestinal symptoms, data on context and environment.
Measured: 7 days
Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary.
Measured: 7 days
Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS.
Measured: 7 days
Psychological symptom scores as measured using the PHQ-9.
Measured: 7 days
Psychological symptom scores as measured using the GAD-7.
Measured: 7 days
Quality of life scores as measured using SF-36.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- Ad A.M. Masclee, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880722
- Sponsor's protocol ID
- NL57473.068.16
- Status last verified
- May 2022
- First submitted
- 28 Jul 2016
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Real-time Patient-Reported Outcome Measure for Chronic Abdominal Pain: The Experience Sampling Method (ESM)
- ClinicalTrials.gov ID
- NCT02880722
- Acronym / sponsor ID
- NL57473.068.16
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome (IBS), Experience Sampling Method (ESM), Ecological Momentary Assessment (EMA), Abdominal pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Grünenthal GmbH
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel syndrome are essential in order to investigate natural disease course and potential treatment options aimed at symptom improvement, since biological markers are currently 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. Aim of this study is to validate an IBS-specific electronic patient-reported outcome measure, based on the Experience Sampling Method-principle, for symptom assessment in IBS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS patients | – | –IBS according to Rome IV criteria. |
| Healthy control group | – | –Healthy volunteers without abdominal complaints fulfilling Rome IV criteria for IBS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IBS patients.
Key inclusion criteria (3 listed)
- Diagnosis of irritable bowel syndrome according to Rome IV criteria.
- Ability to understand and speak the national language of the concerning center.
- Ability to understand how to utilize the ESM-tool.
Key exclusion criteria (3 listed)
- Any organic explanation for the abdominal complaints.
- A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy.
- Start up of regularly used medication from one month before inclusion until the end of study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Abdominal pain scores as measured by the ESM tool.
Time frame: 7 days
Momentary measurements.
8 secondary outcomes
Abdominal pain scores as measured by the end-of-day diary.
Time frame: 7 days
Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.
Time frame: 7 days
Symptom scores (other than abdominal pain) as measured using the ESM-tool.
Time frame: 7 days
Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary.
Time frame: 7 days
Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS.
Time frame: 7 days
Psychological symptom scores as measured using the PHQ-9.
Time frame: 7 days
Psychological symptom scores as measured using the GAD-7.
Time frame: 7 days
Quality of life scores as measured using SF-36.
Time frame: 7 days
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 19 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ad A.M. Masclee, MD, PhD 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?
An observational study of Irritable Bowel Syndrome, 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 3 inclusion and 3 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 19 May 2022. 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?
Abdominal pain scores as measured by the ESM tool. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.