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Long-term Functional Outcome of Children With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT02152241
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

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.


Condition or disease
Inflammatory Bowel Disease

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Study Type : Observational
Estimated Enrollment : 105 participants
Time Perspective: Cross-Sectional
Official Title: Long-term Functional Outcome of Children With Inflammatory Bowel Disease
Study Start Date : June 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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



Primary Outcome Measures :
  1. Functional outcome (highest level of education attained and current occupation) of those with IBD compared to age and sex-matched healthy adult Manitobans [ Time Frame: 12 months ]

    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



Secondary Outcome Measures :
  1. Functional outcome of patients with Crohn's disease (CD) versus those with ulcerative colitis (UC) [ Time Frame: 12 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152241


Locations
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Canada, Manitoba
HSC
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Wael El-Matary, MD Associate Professor, Univeristy of Manitoba

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02152241     History of Changes
Other Study ID Numbers: H2014:155
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by University of Manitoba:
IBD
Crohn
Colitis
Function
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis