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Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03836612
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : November 19, 2019
Sponsor:
Collaborators:
Pfizer
University of Surrey
Information provided by (Responsible Party):
Momentum Data

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease Other: No intervention

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
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Study Type : Observational
Actual Enrollment : 92145 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease (IBD)
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
People with inflammatory bowel disease
Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period
 Other: No intervention
Observation of routine clinical practice
Controls
Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period
 Other: No intervention
Observation of routine clinical practice


Outcome Measures
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Primary Outcome Measures :
  1. Common mental health conditions [ Time Frame: Measured over five years - 2014 to 2018 inclusive ]
    Compare the prevalence of common mental health conditions in people with and without inflammatory bowel disease (IBD) in a community setting, and stratifying by IBD type. Common mental health conditions comprise; depressive episodes, recurrent depressive disorder, and anxiety.

  2. Infection prevalence in people with inflammatory bowel disease [ Time Frame: Measured over five years - 2014 to 2018 inclusive ]
    Describe the prevalence of common, gastrointestinal and viral infections in older people with inflammatory bowel disease. We will also assess factors associated with infection risk.


Secondary Outcome Measures :
  1. Healthcare resource utilization [ Time Frame: Measured over five years - 2014 to 2018 inclusive ]
    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. Healthcare resource utilization comprises primary care attendances, prescriptions of depression and anxiety, prescriptions for IBD, secondary care attendances, and issue of statements of fitness for work.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Patients aged ≥18 years over the study period
  • Registered with a contributing primary care practice for any duration during the study period

Exclusion Criteria:

  • IBD not classifiable or of a type other than UC or Crohn's disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836612


Locations
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United Kingdom
Momentum Data Ltd
London, United Kingdom, WC1X 8QT
Sponsors and Collaborators
Momentum Data
Pfizer
University of Surrey
  Study Documents (Full-Text)

Documents provided by Momentum Data:
Study Protocol and Statistical Analysis Plan  [PDF] December 6, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Momentum Data
ClinicalTrials.gov Identifier: NCT03836612    
Other Study ID Numbers: P003
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data 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.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases