N/A N=95,055

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

Inflammatory Bowel Diseases · Ulcerative Colitis · Crohn Disease

Bottom Line

View on ClinicalTrials.gov: NCT03836612 ↗

Enrolled (actual)

95,055

Serious AEs

—

Results posted

Jan 2023

Primary outcome: Primary: Prevalence of Anxiety Episodes (Crohn's Disease) — 262; 892 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: No intervention (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Momentum Data
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Prevalence of Anxiety Episodes (Crohn's Disease)	262; 892	—
PRIMARY Prevalence of Anxiety Episodes (Ulcerative Colitis)	341; 1221	—
PRIMARY Prevalence of Depressive Episodes (Crohn's Disease)	431; 1233	—
PRIMARY Prevalence of Depressive Episodes (Ulcerative Colitis)	507; 1666	—
PRIMARY Number of People With Depressive Disorder in People With and Without Crohn's Disease	1322; 3911	—
PRIMARY Number of People With Depressive Disorder in People With and Without Ulcerative Colitis	1627; 5676	—
PRIMARY Number of People With at Least One Infection Event in Those With and Without Ulcerative Colitis	5111; 17403; 510; 1365; 2544; 8510	—
PRIMARY Number of People With at Least One Infection Event in Those With and Without Crohn's Disease	3470; 11227; 395; 841; 1797; 5917	—
PRIMARY Number of People With at Least One Sub-infection Event in Those With and Without Ulcerative Colitis	2118; 7143; 100; 288; 1754; 5554	—
PRIMARY Number of People With at Least One Sub-infection Event in Those With and Without Crohn's Disease	1475; 5002; 59; 136; 1059; 3211	—
SECONDARY Healthcare Resource Utilization - Primary Care Visits	6.41; 6.18; 6.78; 4.49	—
SECONDARY Healthcare Resource Utilization - Secondary Care Emergency Attendances	0.455; 0.396; 0.546; 0.259	—
SECONDARY Healthcare Resource Utilization - Fitness for Work Notes	0.311; 0.270; 0.378; 0.215	—
SECONDARY Healthcare Resource Utilization: Medications for Mental Health Conditions - Selective Serotonin Reuptake Inhibitors (SSRIs)	1.328; 1.218; 1.495; 1.046	—
SECONDARY Healthcare Resource Utilization: Medications for Mental Health Conditions - Anxiolytic Medications	0.219; 0.189; 0.264; 0.166	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03836612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.