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Manitoba Inflammatory Bowel Disease Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03262649
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:

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.


Condition or disease
Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 388 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Manitoba Inflammatory Bowel Disease Cohort Study
Actual Study Start Date : March 1, 2002
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : October 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort
Crohn's Disease Cohort
250 individuals in the Crohn's Disease Cohort
ulcerative colitis cohort
108 individuals in the ulcerative colitis cohort



Primary Outcome Measures :
  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 Outcome Measures :
  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)

    1. Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11(suppl 3):89-95.
    2. 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.


Biospecimen Retention:   Samples With DNA
Plasma, DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Complete data were obtained in the first contact from 388 individuals. Over the first two years of the longitudinal cohort study, there was a modest level of attrition and by the time of the 24 month contact 353 respondents continued to participate.

The participating persons have been followed annually with in-person interviews and with semi-annual mail-in surveys. By the end of 5 years 353 persons were still participating (a loss of 1.8%/year).

Participants age was 18-83 and 60% are females. Approximately two thirds live in Winnipeg and the rest live throughout Manitoba including Brandon, Dauphin, Swan River, Flin Flon, Thompson, Winkler and Steinbach. Some subjects live elsewhere in Canada, yet still maintain their participation.

270 subjects were followed until 2016

Criteria

Inclusion Criteria:

  • diagnosed within the previous 7 years with Inflammatory Bowel Disease

Exclusion Criteria:

-


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): NCT03262649


Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Charles Bernstein, MD University of Mantioba
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT03262649    
Other Study ID Numbers: REB#=HS14734 (H2002:040)
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases