NCT03836612

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 95,055 (actual)
• Sponsor: Momentum Data · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Inflammatory Bowel Diseases
• Ulcerative Colitis
• Crohn Disease

Interventions

Type	Name	Description
OTHER	No intervention	Observation of routine clinical practice

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-09-01
• Completion: 2019-11-01
• First posted: 2019-02-11
• Last updated: 2023-01-18
• Results posted: 2023-01-18

Locations

1 site across 1 country: United Kingdom