Inflammatory Bowel DiseasesNCT03836612
Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by Momentum Data at 1 site in United Kingdom.
Trial summary
Ulcerative colitis and Crohn's disease are the commonest types of inflammatory bowel disease (IBD). Both conditions range in severity from no symptoms to being potentially fatal. Both conditions are treated with medications which suppress the immune system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- How many people
- 95,055 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 1 Nov 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All individuals with an existing or incident diagnosis of UC or CD during the study period (2013-2018), defined by the presence of at least one disease-specific diagnostic code will be eligible for inclusion in the IBD cohort. Controls will matched people without IBD matched on age, gender and primary care practice.
Who may be able to join
- Patients aged ≥18 years over the study period
- Registered with a contributing primary care practice for any duration during the study period
Who cannot join
- IBD not classifiable or of a type other than UC or Crohn's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease (IBD)
Ulcerative colitis and Crohn's disease are the commonest types of inflammatory bowel disease (IBD). Both conditions range in severity from no symptoms to being potentially fatal. Both conditions are treated with medications which suppress the immune system. It is not known whether this increases the risk for infections and cancers in these conditions. It is also recognised by healthcare professionals that these conditions cause a considerable amount of psychological distress. However, this has never been measured in a large population sample.
This study will investigate any associations with treatment and new onset infections and cancer. They will also examine the relationship between IBD and common mental health problems (specifically, depression and anxiety) and the impact that these have on the healthcare use (including number of general practitioner [GP] appointments, hospital attendances, and medication prescriptions. Combined, these studies should provide a better understanding of the impact of IBD on affected people and provide evidence to support the correct allocation of healthcare resources.
Read the detailed description
Objective We aim to provide an accurate and contemporary measurement of the current healthcare resource utilisation in people with inflammatory bowel disease (IBD); namely ulcerative colitis (UC) and Crohn's disease (CD). We also aim to provide estimates of infection incidence in this population and the prevalence of common mental health conditions.
Method We will identify UC and CD using algorithms validated for accurately identifying these conditions from primary care records in the United Kingdom (UK). We will identify a prevalent cohort of adults with IBD with the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network over the last decade. We will identify a matched cohort of people without IBD; matched on age, gender and primary care practice. Across these cohorts we will compare healthcare resource utilisation (primary care attendances, number of primary care prescriptions for antidepressant and anxiolytic medications, number of primary care prescriptions for medications used in IBD, recorded secondary care attendances, and issue of statements of fitness for work), incident infections (any common infection, any viral infection, or any gastrointestinal infection), and common mental health conditions (depression and anxiety).
- Being tested
- No intervention
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observation of routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| People with inflammatory bowel disease | Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period Receives: Other: No intervention | |
| Controls | Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Anxiety Episodes (Crohn's Disease)
Compare the prevalence of anxiety episodes in people with and without Crohn's disease.
Number of people with at least one anxiety episode in people.
Measured: Measured over five years - 2014 to 2018 inclusive
Prevalence of Anxiety Episodes (Ulcerative Colitis)
Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis.
Number of people with at least one anxiety episode
Measured: Measured over five years - 2014 to 2018 inclusive
Prevalence of Depressive Episodes (Crohn's Disease)
Compare the prevalence of depressive episodes in people with and without Crohn's disease.
Number of people with at least one depressive episode
Measured: Measured over five years - 2014 to 2018 inclusive
Prevalence of Depressive Episodes (Ulcerative Colitis)
Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis.
Number of people with at least one depressive episode.
Measured: Measured over five years - 2014 to 2018 inclusive
Number of People With Depressive Disorder in People With and Without Crohn's Disease
Compare the prevalence of depressive disorder in people with and without Crohn's disease.
Measured: Measured over five years - 2014 to 2018 inclusive
Number of People With Depressive Disorder in People With and Without Ulcerative Colitis
Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.
Measured: Measured over five years - 2014 to 2018 inclusive
Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis
Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
Measured: Measured over 5 years - 2014 to 2018 inclusive
Number of People With at Least One Infection Event in Those With and Without Crohn's Disease
Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
Measured: Measured over 5 years - 2014 to 2019 inclusive
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis
Sub-infection outcomes: Upper respiratory tract infection (URTI), Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, urinary tract infection (UTI), GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection
Measured: Measured over 5 years - 2014 to 2019 inclusive
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease
Sub-infection outcomes: URTI, Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, UTI, GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection
Measured: Measured over 5 years - 2014 to 2019 inclusive
Secondary outcomes (5)
Healthcare Resource Utilization - Primary Care Visits
Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
Measured: Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization - Secondary Care Emergency Attendances
Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
Measured: Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization - Fitness for Work Notes
Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
Measured: Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)
Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
Measured: Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications
Compare healthcare resource utilization in people with and without IBD, and stratifying by IBD type and compare healthcare resource utilization in people with IBD, with and without mental health illness.
Measured: Measured over five years - 2014 to 2018 inclusive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Feb 2019
- Primary completion1 Sep 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 95,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, University of Surrey
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Study director, Momentum Data Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836612
- Sponsor's protocol ID
- P003
- Status last verified
- Oct 2021
- First submitted
- 17 Jan 2019
- Last updated
- 18 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data (IPD) is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
Publications
Irving P, Barrett K, Tang D, Nijher M, de Lusignan S. Common infections, mental health problems and healthcare use in people with inflammatory bowel disease: a cohort study protocol. Evid Based Ment Health. 2021 May;24(2):82-87. doi: 10.1136/ebmental-2020-300167. Epub 2020 Sep 17.
PubMed 32943436
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT03836612
- Acronym / sponsor ID
- P003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95,055 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer, University of Surrey
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Posted 18 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ulcerative colitis and Crohn's disease are the commonest types of inflammatory bowel disease (IBD). Both conditions range in severity from no symptoms to being potentially fatal. Both conditions are treated with medications which suppress the immune system. It is not known whether this increases the risk for infections and cancers in these conditions. It is also recognised by healthcare professionals that these conditions cause a considerable amount of psychological distress. However, this has never been measured in a large population sample.
This study will investigate any associations with treatment and new onset infections and cancer. They will also examine the relationship between IBD and common mental health problems (specifically, depression and anxiety) and the impact that these have on the healthcare use (including number of general practitioner [GP] appointments, hospital attendances, and medication prescriptions. Combined, these studies should provide a better understanding of the impact of IBD on affected people and provide evidence to support the correct allocation of healthcare resources.
Detailed description
Objective We aim to provide an accurate and contemporary measurement of the current healthcare resource utilisation in people with inflammatory bowel disease (IBD); namely ulcerative colitis (UC) and Crohn's disease (CD). We also aim to provide estimates of infection incidence in this population and the prevalence of common mental health conditions.
Method We will identify UC and CD using algorithms validated for accurately identifying these conditions from primary care records in the United Kingdom (UK). We will identify a prevalent cohort of adults with IBD with the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) network over the last decade. We will identify a matched cohort of people without IBD; matched on age, gender and primary care practice. Across these cohorts we will compare healthcare resource utilisation (primary care attendances, number of primary care prescriptions for antidepressant and anxiolytic medications, number of primary care prescriptions for medications used in IBD, recorded secondary care attendances, and issue of statements of fitness for work), incident infections (any common infection, any viral infection, or any gastrointestinal infection), and common mental health conditions (depression and anxiety).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with inflammatory bowel disease | – | Other: No interventionAdults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period |
| Controls | – | Other: No interventionAdults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals with an existing or incident diagnosis of UC or CD during the study period (2013-2018), defined by the presence of at least one disease-specific diagnostic code will be eligible for inclusion in the IBD cohort. Controls will matched people without IBD matched on age, gender and primary care practice.
Key inclusion criteria (2 listed)
- Patients aged ≥18 years over the study period
- Registered with a contributing primary care practice for any duration during the study period
Key exclusion criteria (1 listed)
- IBD not classifiable or of a type other than UC or Crohn's disease
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 |
|---|---|---|
| No interventionObservation of routine clinical practice | Other | Controls, People with inflammatory bowel disease |
Primary outcome
Prevalence of Anxiety Episodes (Crohn's Disease)
Time frame: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of anxiety episodes in people with and without Crohn's disease. Number of people with at least one anxiety episode in people.
Prevalence of Anxiety Episodes (Ulcerative Colitis)
Time frame: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis. Number of people with at least one anxiety episode
Prevalence of Depressive Episodes (Crohn's Disease)
Time frame: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of depressive episodes in people with and without Crohn's disease. Number of people with at least one depressive episode
Prevalence of Depressive Episodes (Ulcerative Colitis)
Time frame: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis. Number of people with at least one depressive episode.
Number of People With Depressive Disorder in People With and Without Crohn's Disease
Time frame: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of depressive disorder in people with and without Crohn's disease.
Number of People With Depressive Disorder in People With and Without Ulcerative Colitis
Time frame: Measured over five years - 2014 to 2018 inclusive
Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.
Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis
Time frame: Measured over 5 years - 2014 to 2018 inclusive
Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
Number of People With at Least One Infection Event in Those With and Without Crohn's Disease
Time frame: Measured over 5 years - 2014 to 2019 inclusive
Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.
Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis
Time frame: Measured over 5 years - 2014 to 2019 inclusive
Sub-infection outcomes: Upper respiratory tract infection (URTI), Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, urinary tract infection (UTI), GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection
Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease
Time frame: Measured over 5 years - 2014 to 2019 inclusive
Sub-infection outcomes: URTI, Pneumonia, Acute Bronchitis, Influenza, Skin infection, Genital infection, UTI, GI infection subset (only stool culture confirmed Clostridium difficile, Salmonella, Shigella, and Campylobacter infections), Herpes Simplex infection, Herpes Zoster infection
5 secondary outcomes
Healthcare Resource Utilization - Primary Care Visits
Time frame: Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization - Secondary Care Emergency Attendances
Time frame: Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization - Fitness for Work Notes
Time frame: Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)
Time frame: Measured over five years - 2014 to 2018 inclusive
Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications
Time frame: Measured over five years - 2014 to 2018 inclusive
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32943436Irving P, Barrett K, Tang D, Nijher M, de Lusignan S. Common infections, mental health problems and healthcare use in people with inflammatory bowel disease: a cohort study protocol. Evid Based Ment Health. 2021 May;24(2):82-87. doi: 10.1136/ebmental-2020-300167. Epub 2020 Sep 17.
- Individual participant dataSharing planned: Yes. Individual patient data (IPD) is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
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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.
Andrew McGovern, MD study director
Momentum Data Ltd
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 Inflammatory Bowel Diseases and Ulcerative Colitis, run by Momentum Data at 1 site in United Kingdom.
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 2 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: finished, as of the sponsor's last update on 18 Jan 2023. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevalence of Anxiety Episodes (Crohn's Disease) (time frame: Measured over five years - 2014 to 2018 inclusive). The study lists 10 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 NCT03836612, 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 18 Jan 2023.