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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836612
• Other study ID #: P003
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: October 2021
• Source: Momentum Data
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95055
• Est. completion date: November 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Other:
• No intervention
Observation of routine clinical practice

Locations

Country	Name	City	State
United Kingdom	Momentum Data Ltd	London

Sponsors (3)

Lead Sponsor	Collaborator
Momentum Data	Pfizer, University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 over five years - 2014 to 2018 inclusive
Primary	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 over five years - 2014 to 2018 inclusive
Primary	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 over five years - 2014 to 2018 inclusive
Primary	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 over five years - 2014 to 2018 inclusive
Primary	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 over five years - 2014 to 2018 inclusive
Primary	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 over five years - 2014 to 2018 inclusive
Primary	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 over 5 years - 2014 to 2018 inclusive
Primary	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 over 5 years - 2014 to 2019 inclusive
Primary	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 over 5 years - 2014 to 2019 inclusive
Primary	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 over 5 years - 2014 to 2019 inclusive
Secondary	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 over five years - 2014 to 2018 inclusive
Secondary	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 over five years - 2014 to 2018 inclusive
Secondary	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 over five years - 2014 to 2018 inclusive
Secondary	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 over five years - 2014 to 2018 inclusive
Secondary	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 over five years - 2014 to 2018 inclusive