Irritable Bowel SyndromeNCT04859972
How Well do Primary Care Doctors in Region Örebro County, Sweden Follow Diagnostic Guidelines of IBS?
An observational study of Irritable Bowel Syndrome, run by Region Örebro County.
Trial summary
The aim of this project is to investigate the implementation of the Rome criteria in daily primary care clinical practice and adherence of general practitioners (GPs) to recommended diagnostic approaches for IBS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Diagnosis of IBS
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2021to May 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with IBS within primary care of Region Örebro County 2015-2019.
Who may be able to join
- All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2015-2019.
Who cannot join
- Patients < 18 years or > 65 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adherence of Primary Care Doctors to Guidelines of Making a Positive Diagnosis of IBS.
The aim of this project is to investigate the implementation of the Rome criteria in daily primary care clinical practice and adherence of general practitioners (GPs) to recommended diagnostic approaches for IBS.
Read the detailed description
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder. To diagnose IBS, the so-called Rome Criteria combined with limited laboratory tests should be used. However, within the primary care, too much unnecessary diagnostics, for example radiology and endoscopy, are used. This is meaningless, stressful for the patient and they also cost a lot of money.
In Örebro Region there are 29 public general health centers. Approximately 300.000 inhabitants are listed within these health centers. Approximately 150 doctors are currently working within the primary health care of Örebro Region. The software program Medrave and the electronic patient register in Örebro Region allows to search for the International Statistical Classification of Diseases (ICD-10) for IBS (K58.9 and K58.0) This allows retrospective research regarding diagnosing IBS, the used diagnostic tools, comorbidities, as well as the different treatments that were used.
Patients diagnosed with IBS will be identified by ICD-code K.58. By evaluating their patient register it will be determined how the GP has made the IBS diagnosis. Patients will fall into three categories: those who received a positive IBS diagnosis using the Rome criteria, those who received a negative IBS diagnosis and those whose patient record is lacking sufficient information.
Data will also include demographics, number of GP contacts and referrals to specialists, diagnostic procedures, treatments, and relevant somatic, psychological and psychiatric comorbidities. Data regarding substance abuse will be collected as well.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Diagnosis of IBS
- Keywords
- Irritable Bowel Syndrome, Rome IV, Functional gastrointestinal disorders
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of IBSDiagnostic test
Diagnosis of IBS according to ICD-10
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with IBS | Patients diagnosed with IBS within primary care in Region Örebro County between 2015- 2019, identified by ICD-code K.58. Receives: Diagnostic Test: Diagnosis of IBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to guidelines of making a positive diagnosis of IBS within primary care.
The proportion of patients that received a positive IBS diagnosis versus the proportion of patients that received a negative IBS diagnosis.
Measured: 2015-2019
Secondary outcomes (4)
Prevalence of diarrhea-predominant IBS and IBS without diarrhea.
Proportion of patients with diarrhea-predominant IBS versus IBS without diarrhea
Measured: 2015-2019
The proportion of IBS patients that have one or more comorbidities.
Data will be collected about the following comorbidities: depression (F32, F33 and F41.2), anxiety (F41), somatization syndrome (F45), posttraumatic stress syndrome (F43.1), sleeping disorder (G47.9), urinary incontinence (N39.3 and N39.4), fecal incontinence (R15.9), migraine (G43), headache (R51.9 and G44.2), menstruation symptoms (N92 and N94), fibromyalgia (M79.7), Ehlers Danlos syndrome (Q79.6), other unspecific muskuloskeletal pain (M79) and functional dyspepsia (K30.9).
Measured: 2015-2019
The proportion of IBS patients with post-infectious IBS.
The presence of gastroenteritis (A09.9) that precedes the diagnosis of IBS.
Measured: 2015-2019
The proportion of IBS patients with substance abuse.
Data will be collected regarding substance abuse which is defined by alcohol (F10), opioids (F11), cannabis (F12), sedatives and hypnotics (F13) and Tobacco (F17).
Measured: 2015-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start22 Nov 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionMay 2023 (estimated)
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
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michiel van Nieuwenhoven, Associate Professor, M.D. PhD., Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859972
- Sponsor's protocol ID
- 277069
- Status last verified
- Mar 2021
- First submitted
- 22 Apr 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence of Primary Care Doctors to Guidelines of Making a Positive Diagnosis of IBS.
- ClinicalTrials.gov ID
- NCT04859972
- Acronym / sponsor ID
- 277069
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Rome IV, Functional gastrointestinal disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 22 Nov 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 26 Apr 2021 (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.
The aim of this project is to investigate the implementation of the Rome criteria in daily primary care clinical practice and adherence of general practitioners (GPs) to recommended diagnostic approaches for IBS.
Detailed description
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder. To diagnose IBS, the so-called Rome Criteria combined with limited laboratory tests should be used. However, within the primary care, too much unnecessary diagnostics, for example radiology and endoscopy, are used. This is meaningless, stressful for the patient and they also cost a lot of money.
In Örebro Region there are 29 public general health centers. Approximately 300.000 inhabitants are listed within these health centers. Approximately 150 doctors are currently working within the primary health care of Örebro Region. The software program Medrave and the electronic patient register in Örebro Region allows to search for the International Statistical Classification of Diseases (ICD-10) for IBS (K58.9 and K58.0) This allows retrospective research regarding diagnosing IBS, the used diagnostic tools, comorbidities, as well as the different treatments that were used.
Patients diagnosed with IBS will be identified by ICD-code K.58. By evaluating their patient register it will be determined how the GP has made the IBS diagnosis. Patients will fall into three categories: those who received a positive IBS diagnosis using the Rome criteria, those who received a negative IBS diagnosis and those whose patient record is lacking sufficient information.
Data will also include demographics, number of GP contacts and referrals to specialists, diagnostic procedures, treatments, and relevant somatic, psychological and psychiatric comorbidities. Data regarding substance abuse will be collected as well.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with IBS | – | Diagnostic Test: Diagnosis of IBSPatients diagnosed with IBS within primary care in Region Örebro County between 2015- 2019, identified by ICD-code K.58. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with IBS within primary care of Region Örebro County 2015-2019.
Key inclusion criteria (1 listed)
- All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2015-2019.
Key exclusion criteria (1 listed)
- Patients < 18 years or > 65 years
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 |
|---|---|---|
| Diagnosis of IBSDiagnosis of IBS according to ICD-10 | Diagnostic test | Patients diagnosed with IBS |
Primary outcome
Adherence to guidelines of making a positive diagnosis of IBS within primary care.
Time frame: 2015-2019
The proportion of patients that received a positive IBS diagnosis versus the proportion of patients that received a negative IBS diagnosis.
4 secondary outcomes
Prevalence of diarrhea-predominant IBS and IBS without diarrhea.
Time frame: 2015-2019
The proportion of IBS patients that have one or more comorbidities.
Time frame: 2015-2019
The proportion of IBS patients with post-infectious IBS.
Time frame: 2015-2019
The proportion of IBS patients with substance abuse.
Time frame: 2015-2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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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.
Michiel van Nieuwenhoven, Associate Professor, M.D. PhD. principal investigator
Region Örebro County
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Region Örebro County.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jussi Rauma, Ph.D. student, M.D. (+46702484167, jussi.rauma@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to guidelines of making a positive diagnosis of IBS within primary care. (time frame: 2015-2019). 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 23 Nov 2021.