Long-term Functional Outcome of Children With Inflammatory Bowel Disease

Inflammatory bowel diseases (IBD) are group of immune system disorders characterized by a chronic course with remission and relapses. Canada is one of the countries with the highest prevalence and incidence rates of IBD with 25% of patients present in children and adolescents.

As with any chronic illness, IBD diagnosed early in life has a significant impact on the physical, emotional and social development of those affected. Consequently, it is logical to speculate that patients with IBD may not do as well in education levels or employment status attained compared to their peers without IBD. If this were the case, then interventions could begin in childhood to better prepare patients with IBD for the challenges of living with a chronic disease. Alternatively, if it is shown that they reach comparable social or employment milestones as adults compared to unaffected peers then this would be enormously reassuring to children and their parents.

Properly designed studies to help in defining more appropriate interventions to these patients are needed.

The proposed study includes circulating a survey to evaluate the functioning level of adult patients with IBD who were diagnosed during their childhood. The participants will be asked a series of questions regarding their highest level of educational achievement, the nature of their current employment, and their current marital status. The question format will parallel that of the Canadian Community Health Survey from which data from an age matched healthy adult Manitobans will be extracted and used as another control group. Responses will be analysed for any possible differences between these groups.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease

• Study Type: Observational
• Enrollment (Anticipated): 105

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • HSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The participant population will be comprised of adult patients who were initially diagnosed with IBD in childhood or adolescence (diagnosis was made < age of 18 years) and who were followed by the Section of Pediatric Gastroenterology at the Winnipeg Children's Hospital from 1974 - 2009.

Controls: age and sex-matched control group will be generated using the Canadian Community Health Survey (CCHS) 2012 (16) with access through the local Research and Data Centre (RDC).

Description

Inclusion Criteria:

• adult patients who were initially diagnosed with IBD in childhood or adolescence (diagnosis was made < age of 18 years) and who were followed by the Section of Pediatric Gastroenterology at the Winnipeg Children's Hospital from 1974 - 2009.

Exclusion Criteria:

• Patients in whom the diagnosis of IBD was not fully established following the current North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) guidelines for diagnosing IBD i.e. had clinical, radiologic and endoscopic evidence of IBD (2).
• Control participants with other chronic debilitating diseases (e.g. malignancy, rheumatoid arthritis, multiple sclerosis, etc..) that may affect quality of life and functional outcome

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with IBD; Adult patients with IBD diagnosed during childhood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome (highest level of education attained and current occupation) of those with IBD compared to age and sex-matched healthy adult Manitobans	The highest level of education attained and current occupation will be obtained from participants using structured questionnaire (non-validated interview questionnaire) e.g. Employed: Y N If No, Unemployed Y N, Disabled Y N , Homemaker Y N Student Y N, Retired Y N Is the cause of not working disease-related Y N	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome of patients with Crohn's disease (CD) versus those with ulcerative colitis (UC)	The same structured questionnaire tool will be used. Data will be collected on the highest level of education achieved and the current occupation including any periods of unemployment and if this is disease-related or not	12 months

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Wael El-Matary, MD, Associate Professor, Univeristy of Manitoba

Publications and helpful links

General Publications

• El-Matary W, Dufault B, Moroz SP, Schellenberg J, Bernstein CN. Education, Employment, Income, and Marital Status Among Adults Diagnosed With Inflammatory Bowel Diseases During Childhood or Adolescence. Clin Gastroenterol Hepatol. 2017 Apr;15(4):518-524. doi: 10.1016/j.cgh.2016.09.146. Epub 2016 Oct 4.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 26, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: IBD; Function; Colitis; Crohn
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: H2014:155