Risk of Mental Health Conditions in Children and Young Adults With Inflammatory Bowel Disease and Influence on Health

Sponsor
Momentum Data (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05206734
Collaborator
Optimum Patient Care (Other)
1,800
Enrollment
1
Location
10.8
Anticipated Duration (Months)
166
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a large population-based analysis in the United Kingdom (UK) using routine primary care data to investigate the risk of mental health conditions in children, adolescents and young adults with Inflammatory Bowel Disease, compared to those without Inflammatory Bowel Disease. The study will also compare the impacts on quality-of-life outcomes and use of healthcare services between people with Inflammatory Bowel Disease with and without mental health conditions.

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 with a diagnosis of Inflammatory Bowel Disease, compared to matched population controls without a diagnosis of Inflammatory Bowel Disease. The secondary objective is to determine the severity of mental health outcomes in those with and without a diagnosis of Inflammatory Bowel Disease.

Stream 2 primary objective is to determine the impact of mental health conditions in children, adolescents and young adults with Inflammatory Bowel Disease 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 Inflammatory Bowel Disease severity, such as medication use, surgical intervention, nutritional supplement prescriptions and markers of nutritional status including underweight or growth retardation in children and adolescents, between those with and without mental health conditions. Then to compare healthcare resource utilisation in children, adolescents and young adults with Inflammatory Bowel Disease with and without mental health conditions.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1800 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Jan 5, 2022
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Cases

All incident cases of Inflammatory Bowel Disease (IBD); comprising of Ulcerative Colitis, Crohn's Disease and IBD Unclassified in children, adolescents and young adults up to their 25th birthday. Cases will be defined based on an algorithm using diagnostic codes from the electronic medical record (EMR).

Other: Exposure of mental health condition
Primary: Composite of all chronic psychological conditions (depression, anxiety, eating disorders, body image disorders, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, and post-traumatic stress disorder). Major recurrent depression or treated depressive episode. Non-phobia related anxiety episode or disorder. Secondary: Self-harm, suicide attempt or suicide related codes, other chronic psychiatric conditions (eating disorders, body image disorders, attention-deficit disorder, behavioural disorders, adjustment disorders, acute stress disorder, schizophrenia, bipolar disorder and post-traumatic stress disorder. Problems with sleep.

Controls

People without a diagnosis in their electronic medical record (ERM) of Inflammatory Bowel Disease, matched on age group, sex, ethnicity (consistent with UK census categories: White, Asian, Black, Mixed, Other), index of multiple deprivation based on postcode, and by practice where numbers allow.

Other: Exposure of mental health condition
Primary: Composite of all chronic psychological conditions (depression, anxiety, eating disorders, body image disorders, attention-deficit disorder, behavioural disorders, adjustment disorder, acute stress disorder, and post-traumatic stress disorder). Major recurrent depression or treated depressive episode. Non-phobia related anxiety episode or disorder. Secondary: Self-harm, suicide attempt or suicide related codes, other chronic psychiatric conditions (eating disorders, body image disorders, attention-deficit disorder, behavioural disorders, adjustment disorders, acute stress disorder, schizophrenia, bipolar disorder and post-traumatic stress disorder. Problems with sleep.

Outcome Measures

Primary Outcome Measures

  1. Stream 1 - Primary Outcome: Prevalence and cumulative incidence of mental health conditions in children, adolescents and young adults with IBD [Date of Inflammatory Bowel Disease diagnosis for cases or for controls date of diagnosis for their matched counterpart. End of follow-up will be the first of; point of data extraction, patients 25th birthday or loss to follow-up.]

    Using routinely collected information from patient electronic medical record (EMR) data, we will investigate the prevalence and cumulative incidence of each mental health condition in cases with a diagnosis of IBD and controls without a diagnosis of IBD. Prevalence and cumulative incidence will be stratified by IBD type (Ulcerative Colitis, Crohn's Disease or IBD Unclassified). IBD classification status and mental health conditions will be identified on the basis diagnosis codes within their EMR.

  2. Stream 2 - Primary Outcome: Impact of mental health conditions in children, adolescents and young adults with IBD [Index date of 01/01/2015 with 5 years of follow-up.]

    Determine the association between mental health conditions in children, adolescents and young adults with Inflammatory Bowel Disease on quality-of-life indicators. These indicators will be gathered from the routinely collected EMR data, such as records for absence from work or school, unemployment, sleep disturbance and substance abuse.

Secondary Outcome Measures

  1. Stream 1 - Secondary outcome: Sequelae of mental health conditions in children, adolescents and young adults with IBD [Date of Inflammatory Bowel Disease diagnosis for cases or for controls date of diagnosis for their matched counterpart. End of follow-up will be the first of; point of data extraction, patients 25th birthday or loss to follow-up.]

    Determine the sequelae of mental health conditions in people with and without Inflammatory Bowel Disease. Mental health disease information will be gathered from routinely collected EMR data using diagnosis codes for a range of mental health conditions, comprising of three core phenotypes: anxiety/panic disorders, major depressive disorders or depressive episodes, and other psychological conditions. Mental health condition sequelae will include any coded episode of self-harm or suicide, the development of additional chronic mental health conditions, and recorded sleep disturbance.

  2. Stream 2 - Secondary outcome - IBD severity markers [Index date of 01/01/2015 with up to 5 years of follow-up.]

    Compare indicators of IBD severity in children, adolescents and young adults with and without mental health conditions. Indicators for disease severity will be gathered from the routinely collected EMR data, including records for medication use, surgical intervention, nutritional supplement prescriptions and markers of nutritional status including records of underweight or codes for growth retardation in children and adolescents, between those with and without mental health conditions.

  3. Stream 2 - Secondary outcome - Healthcare utilisation [Index date of 01/01/2015 with up to 5 years of follow-up.]

    Compare healthcare resource utilisation in children, adolescents and young adults with Inflammatory Bowel Disease with and without mental health conditions. Healthcare resource utilisation will comprise of records of number of primary care contacts and primary care records reporting hospital admission. Hospital admission will be separated into general admission (including for IBD) and psychiatric admission.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Momentum Data LtdLondonUnited KingdomWC1X 8QT

Sponsors and Collaborators

  • Momentum Data
  • Optimum Patient Care

Investigators

  • Principal Investigator: Andrew McGovern, MD, Momentum Data

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Momentum Data
ClinicalTrials.gov Identifier:
NCT05206734
Other Study ID Numbers:
  • P043
First Posted:
Jan 25, 2022
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022

Study Results

No Results Posted as of Jan 25, 2022