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

NCT03836612 | Completed Results

• 1 other identifier: P003
• Study Type: observational
• Target: 95,055
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Healthcare Resource Utilization - Primary Care Visits

  Measured over five years - 2014 to 2018 inclusive

• Healthcare Resource Utilization - Secondary Care Emergency Attendances

  Measured over five years - 2014 to 2018 inclusive

• Healthcare Resource Utilization - Fitness for Work Notes

  Measured over five years - 2014 to 2018 inclusive

• Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)

  Measured over five years - 2014 to 2018 inclusive

• Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications

  Measured over five years - 2014 to 2018 inclusive

Study Arms (2)

People with inflammatory bowel disease

Adults (18+) with inflammatory bowel disease registered with a contributing GP practice during the study period

Other: No intervention

Controls

Adults (18+) without inflammatory bowel disease registered with a contributing GP practice during the study period

Other: No intervention

Interventions

No intervention OTHER

Observation of routine clinical practice

Controls; People with inflammatory bowel disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• IBD not classifiable or of a type other than UC or Crohn's disease

Sponsors & Collaborators

• Momentum Data: lead
• Pfizer: collaborator
• University of Surrey: collaborator

Study Sites (1)

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32943436 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Results Point of Contact

• Title: Dr Peter Irving
• Organization: St Thomas' Hospital, London

peter.irving@gstt.nhs.uk

020 7188 7188

Study Officials

• Andrew McGovern, MD

  Momentum Data Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 11, 2019
• Study Start: February 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 18, 2023
• Results First Posted: January 18, 2023

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
• Access Criteria: As above

Locations

GB (1)