Clinical trial NCT02152241: Long-term Functional Outcome of Children With Inflammatory Bowel Disease
Official title: Long-term Functional Outcome of Children With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: IBD
Crohn
Colitis
Function
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 105
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
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).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional outcome (highest level of education attained and current occupation) of those with IBD compared to age and sex-matched healthy adult Manitobans
timeFrame: 12 months
Secondary outcomes:
measure: Functional outcome of patients with Crohn's disease (CD) versus those with ulcerative colitis (UC)
timeFrame: 12 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: HSC
state: Manitoba
Study officials:
affiliation: Associate Professor, Univeristy of Manitoba
name: Wael El-Matary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.