Long-term Functional Outcome of Children With Inflammatory Bowel Disease

NCT02152241 | Completed

• 1 other identifier: H2014:155
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Keywords

IBD; Crohn; Colitis; Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional outcome of patients with Crohn's disease (CD) versus those with ulcerative colitis (UC)

  12 months

Study Arms (1)

Patients with IBD

Adult patients with IBD diagnosed during childhood

Eligibility Criteria

• Age: 24 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

HSC

Winnipeg, Manitoba, Canada

Location

Related Publications (1)

• 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.

  PMID: 27717842 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases

Study Officials

• Wael El-Matary, MD

  Associate Professor, Univeristy of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: June 2, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

CA (1)