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NCT Number: NCT03262649

Manitoba Inflammatory Bowel Disease Cohort Study

The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study participants were drawn from a population-based research registry.

The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys and annually with interviews. Diagnosis and disease type were verified by chart review.

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Key information

About this study

The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study, initiated in 2002, is study of adults with IBD who have been tracked prospectively through annual clinical interviews and semiannual surveys. The participants were drawn from a validated population-based research registry, which identified and recruited individuals using an administrative definition of IBD from the comprehensive health data base of Manitoba Health, the single insurer that provides health care to all residents in the province.

The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys and annually with interviews. Diagnosis and disease type were verified by chart review. It has been demonstrated that the Cohort is representative of the provincial IBD population as a whole, with comparable age distribution, sex distribution, disease duration, and rural/urban residence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed within the previous 7 years with Inflammatory Bowel Disease

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Genetic Associations

    Time frame: 2010 to 2016

    Single Nucleotide Variations (SNPs) in gene encoding for membrane transporter proteins were investigated for associations with both IBDs. Target genes included SLC23A1, SLC22A4, SLC22A5, SLC22A23, SLC2A14, SLC2A2 but analyses are not limited to these.

Secondary outcomes

  1. Psychological Functioning 1

    Time frame: 2010-2014

    The validated 7-item Mastery scale assesses the degree to which persons feel they have some control or mastery over their life to handle day-to-day challenges.

  2. Self Efficacy

    Time frame: 2010-2014

    The IBD- Self Efficacy (SE) is a 29-item scale developed by Keefer et al. (1) based on patient interview, validated self-efficacy measures for other diseases. The instrument assesses the level of confidence in managing various disease-related "tasks," with item scores ranging from 1 (not at all) to 10 (totally), and higher scores reflecting greater disease self-management efficacy. Items were grouped conceptually into 4 subscales, reflecting domains identified by patients with IBD as important [1] managing stress and emotions (sample items: keep from feeling sad; do something to reduce stress); [2] managing medical care (sample items: take medication at instructed times; work out differences with doctors); [3] managing symptoms and disease (sample items: keep diarrhea/urgency from interfering; decrease fatigue); [4] maintaining remission (sample items: engage in self-care; maintain sense of well-being).

  3. Disability

    Time frame: 2010-2014

    The Sheehan Disability Scale is a commonly used and validated instrument that measures disease interference in 3 primary domains of life: work, social, and home, based on a visual analog scale from 0 (no interference) to 10 (very severe interference). (1,2)

    • Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11(suppl 3):89-95.
    • Leon AC, Olfson M, Portera L, et al. Assessing psychiatric impairment in primary care with the Sheehan Disability Scale. Int J Psychiatry Med. 1997;27:93-105.
  4. Health and Quality of Life 1

    Time frame: 2010-2014

    Perceived health was assessed using the General Health item from the Medical Outcome Survey Short Form 36, (1) which asks participants to characterize their health in the past year, using 5 response categories from "Excellent" to "Poor."

  5. Disease Activity 1

    Time frame: 2010-2014

    Current disease activity was assessed using standardized clinical indices, the Harvey-Bradshaw index for CD.

  6. Disease Activity 2

    Time frame: 2010-2014

    Current disease activity was assessed using standardized clinical indices, the modified Powell-Tuck index for UC.

  7. Disease Activity 3

    Time frame: 2010-2014

    Recent disease activity was measured with the Manitoba IBD Index

  8. Psychological Functioning 2

    Time frame: 2010-2014

    The Cohen Perceived Stress Scale is a 14-item questionnaire, with a 5-point Likert response format, that assesses the individual's appraisal of their stress "load" related to chronic and acute stressors.

  9. Psychological Functioning 3

    Time frame: 2010-2014

    The Brief Symptom Inventory is a well-established measure of current emotional distress related to multiple psychological symptoms, consisting of 53 items.

  10. Psychological Functioning 4

    Time frame: 2010-2014

    The Psychological Well-being Manifestations Scale consists of 25 items that query 6 general domains of positive experience using a 5-point Likert frequency scale, with higher scores indicating a greater sense of well-being.

  11. Health and Quality of Life 2

    Time frame: 2010-2014

    The 32-item Inflammatory Bowel Disease Questionnaire is a validated measure that has been extensively used in IBD studies to assess disease-specific quality of life.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2002
Primary completion
2016
Study completion
2016
First posted
Aug 25, 2017
Registry last updated
Aug 25, 2017

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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