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OpenTrials
Completed

NCT Number: NCT02152241

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.

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Key information

Age range

24 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HSC

Winnipeg, Manitoba, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2014
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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