Clinical trial NCT05206734: Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health
Official title: Incidence of Psychological Comorbidities in Paediatric and Young Adults With Inflammatory Bowel Disease, and the Impacts on Quality-of-life, Disease Severity and Resource Utilisation: A Population-based Cohort Study in the United Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Depressive Episode
Recurrent Depressive Disorder
Anxiety Disorder
Psychological Disorder
Self Harm
Suicide, Attempted
Parasuicide
Eating Disorders
Body Image Disorder
Attention Deficit Hyperactivity Disorder
Behavioral Disorder
Adjustment Disorders
Acute Stress Disorder
Schizophrenia
Bipolar Disorder
Post-traumatic Stress Disorder
Sleep Disturbance
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
Collaborators: name: Optimum Patient Care
First posted: 2022-01-25
Enrollment: 19469
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases of IBD in childhood and young adults and age, gender and GP matched controls.

Brief summary: This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the impacts on quality-of-life outcomes and use of healthcare services in people aged 5 - 25 years diagnosed with Inflammatory Bowel Disease (IBD) and the impacts of mental health conditions in those diagnosed with IBD.

Detailed description: This study will use routinely electronic medical record (EMR) data from primary care practices within the Optimum Patient Care Research Database (OPCRD).

Stream 1 primary objective is to compare the prevalence and cumulative incidence of mental health conditions in children, adolescents and young adults (aged 5-25 years) with a diagnosis of Inflammatory Bowel Disease (IBD), compared to matched population controls without a diagnosis of IBD. The secondary objective is to determine the severity of mental health outcomes in those with and without a diagnosis of IBD.

Stream 2 primary objective is to determine the impact of mental health conditions in children, adolescents and young adults (aged 5-25 years) diagnosed with IBD on quality-of-life indicators, such as records for absence from work or school, unemployment, sleep disturbance and substance abuse.

The secondary objectives are to compare indicators of IBD severity, such as medication use, surgical intervention, nutritional supplement prescriptions and markers of nutritional status including underweight or growth retardation,and healthcare resource utilisation.These impacts and indicators will be assessed using participants that have been diagnosed with IBD, comparing those with the presence of a mental health condition to those without a mental health condition.

Eligibility criteria: Inclusion Criteria:

* Aged between 5 years and 25 years
* Registration with a general practices (GP) contributing routinely collected electronic healthcare data to the Optimum Patient Care Research Database (OPCRD) for more than 6 months during the follow up period
* A recorded diagnosis of IBD in the clinical record (cases)

Exclusion Criteria:

• None

Primary outcomes:
measure: Stream 1: Percentage of Participants Who Developed Any Mental Health Condition
timeFrame: 5 years
measure: Stream 1: Relative Risk of Any Mental Health Condition
timeFrame: Retrospective data assessed from 2010-2020, up to 10 years
measure: Stream 2: Relative Risk of Bowel Symptoms (Quality of Life Indicator)
timeFrame: 5 years of follow-up.
measure: Stream 2: Relative Risk of Sleep Disturbance (Quality of Life Indicator)
timeFrame: 5 years of follow-up.
measure: Stream 2: Relative Risk of Low Mood (Emotional Function)
timeFrame: 5 years of follow-up.
Secondary outcomes:
measure: Stream 1: Lifetime Risk of Developing a Mental Health Condition
timeFrame: Retrospective data assessed from 2010-2020, up to 10 years
measure: Stream 2: Relative Risk of Increased Primary Care Utilisation
timeFrame: 5 years of follow-up.
measure: Stream 2: Relative Risk of Increased Hospital Admissions
timeFrame: 5 years of follow-up.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Ltd
Study officials:
affiliation: Momentum Data
name: Andrew McGovern, MD
role: PRINCIPAL_INVESTIGATOR
References: