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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

Tracking Information
First Submitted Date January 17, 2019
First Posted Date February 11, 2019
Last Update Posted Date November 19, 2019
Actual Study Start Date February 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 7, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 7, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease
Official Title Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease (IBD)
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Inflammatory Bowel Diseases
  • Ulcerative Colitis
  • Crohn Disease
Intervention Other: No intervention
Observation of routine clinical practice
Study Groups/Cohorts
  • People with inflammatory bowel disease
    Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period
    Intervention: Other: No intervention
  • Controls
    Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period
    Intervention: Other: No intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 18, 2019)
92145
Original Estimated Enrollment
 (submitted: February 7, 2019)
4000
Actual Study Completion Date November 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03836612
Other Study ID Numbers P003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Momentum Data
Study Sponsor Momentum Data
Collaborators
  • Pfizer
  • University of Surrey
Investigators Not Provided
PRS Account Momentum Data
Verification Date November 2019