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OpenTrials
Completed

NCT Number: NCT03836612

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Observation of routine clinical practice

Primary outcomes

  1. Prevalence of Anxiety Episodes (Crohn's Disease)

    Time frame: Measured over five years - 2014 to 2018 inclusive

    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.

  2. Prevalence of Anxiety Episodes (Ulcerative Colitis)

    Time frame: Measured over five years - 2014 to 2018 inclusive

    Compare the prevalence of anxiety episodes in people with and without Ulcerative Colitis.

    Number of people with at least one anxiety episode

  3. Prevalence of Depressive Episodes (Crohn's Disease)

    Time frame: Measured over five years - 2014 to 2018 inclusive

    Compare the prevalence of depressive episodes in people with and without Crohn's disease.

    Number of people with at least one depressive episode

  4. Prevalence of Depressive Episodes (Ulcerative Colitis)

    Time frame: Measured over five years - 2014 to 2018 inclusive

    Compare the prevalence of depressive episodes in people with and without Ulcerative Colitis.

    Number of people with at least one depressive episode.

  5. Number of People With Depressive Disorder in People With and Without Crohn's Disease

    Time frame: Measured over five years - 2014 to 2018 inclusive

    Compare the prevalence of depressive disorder in people with and without Crohn's disease.

  6. Number of People With Depressive Disorder in People With and Without Ulcerative Colitis

    Time frame: Measured over five years - 2014 to 2018 inclusive

    Compare the prevalence of depressive disorder in people with and without Ulcerative Colitis.

  7. Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis

    Time frame: Measured over 5 years - 2014 to 2018 inclusive

    Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.

  8. Number of People With at Least One Infection Event in Those With and Without Crohn's Disease

    Time frame: Measured over 5 years - 2014 to 2019 inclusive

    Number of people with at least one infection event during follow up for any common infection, gastrointestinal infection, and any viral infection.

  9. Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis

    Time frame: Measured over 5 years - 2014 to 2019 inclusive

    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

  10. Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease

    Time frame: Measured over 5 years - 2014 to 2019 inclusive

    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

Secondary outcomes

  1. Healthcare Resource Utilization - Primary Care Visits

    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.

  2. Healthcare Resource Utilization - Secondary Care Emergency Attendances

    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.

  3. Healthcare Resource Utilization - Fitness for Work Notes

    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.

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

    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.

  5. Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications

    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.

Sponsors and collaborators

Lead sponsor

Momentum Data

Industry

Collaborators

  • Pfizer
  • University of Surrey

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2019
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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