Healthcare Resource Utilisation, Common Mental Health Problems, and Infections in People With Inflammatory Bowel Disease
NCT ID: NCT03836612
Last Updated: 2023-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
95055 participants
OBSERVATIONAL
2019-02-01
2019-11-01
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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People with inflammatory bowel disease
Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period
No intervention
Observation of routine clinical practice
Controls
Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period
No intervention
Observation of routine clinical practice
Interventions
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No intervention
Observation of routine clinical practice
Eligibility Criteria
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Inclusion Criteria
* Registered with a contributing primary care practice for any duration during the study period
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
University of Surrey
OTHER
Momentum Data
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew McGovern, MD
Role: STUDY_DIRECTOR
Momentum Data Ltd
Locations
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Momentum Data Ltd
London, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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P003
Identifier Type: -
Identifier Source: org_study_id
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