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Inflammatory Bowel DiseasesNCT03262649

Manitoba Inflammatory Bowel Disease Cohort Study

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University of Manitoba.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
How many people
388 participants
Where
No sites listed yet
Study dates
1 Mar 2002to 1 Oct 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • diagnosed within the previous 7 years with Inflammatory Bowel Disease

Who cannot join

  • -

About this 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.

Read the 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.

Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03262649
Study groupRoleWhat they receive
Crohn's Disease Cohort250 individuals in the Crohn's Disease Cohort
ulcerative colitis cohort108 individuals in the ulcerative colitis cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genetic Associations

    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.

    Measured: 2010 to 2016

Secondary outcomes (11)

  1. Psychological Functioning 1

    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.

    Measured: 2010-2014

  2. Self Efficacy

    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).

    Measured: 2010-2014

  3. Disability

    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.

    Measured: 2010-2014

  4. Health and Quality of Life 1

    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."

    Measured: 2010-2014

  5. Disease Activity 1

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

    Measured: 2010-2014

  6. Disease Activity 2

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

    Measured: 2010-2014

  7. Disease Activity 3

    Recent disease activity was measured with the Manitoba IBD Index

    Measured: 2010-2014

  8. Psychological Functioning 2

    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.

    Measured: 2010-2014

  9. Psychological Functioning 3

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

    Measured: 2010-2014

  10. Psychological Functioning 4

    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.

    Measured: 2010-2014

  11. Health and Quality of Life 2

    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.

    Measured: 2010-2014

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start1 Mar 2002
  3. Primary completion1 Mar 2016
  4. Study completion1 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03262649
Sponsor's protocol ID
REB#=HS14734 (H2002:040)
Status last verified
Aug 2017
First submitted
14 Aug 2017
Last updated
25 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Benchimol EI, Kaplan GG, Otley AR, Nguyen GC, Underwood FE, Guttmann A, Jones JL, Potter BK, Catley CA, Nugent ZJ, Cui Y, Tanyingoh D, Mojaverian N, Bitton A, Carroll MW, deBruyn J, Dummer TJB, El-Matary W, Griffiths AM, Jacobson K, Kuenzig ME, Leddin D, Lix LM, Mack DR, Murthy SK, Sanchez JNP, Singh H, Targownik LE, Vutcovici M, Bernstein CN. Rural and Urban Residence During Early Life is Associated with Risk of Inflammatory Bowel Disease: A Population-Based Inception and Birth Cohort Study. Am J Gastroenterol. 2017 Sep;112(9):1412-1422. doi: 10.1038/ajg.2017.208. Epub 2017 Jul 25.

    PubMed 28741616

  • Marrie RA, Sellers EAC, Chen H, Fransoo R, Bernstein CN, Hitchon CA, Peschken CA, Garland A. Markedly increased incidence of critical illness in adults with Type 1 diabetes. Diabet Med. 2017 Oct;34(10):1414-1420. doi: 10.1111/dme.13404. Epub 2017 Jul 12.

    PubMed 28626956

  • Restall GJ, Simms AM, Walker JR, Haviva C, Graff LA, Sexton KA, Miller N, Targownik LE, Bernstein CN. Coping with Inflammatory Bowel Disease: Engaging with Information to Inform Health-Related Decision Making in Daily Life. Inflamm Bowel Dis. 2017 Aug;23(8):1247-1256. doi: 10.1097/MIB.0000000000001141.

    PubMed 28498156

  • Singh H, Nugent Z, Yu BN, Lix LM, Targownik LE, Bernstein CN. Higher Incidence of Clostridium difficile Infection Among Individuals With Inflammatory Bowel Disease. Gastroenterology. 2017 Aug;153(2):430-438.e2. doi: 10.1053/j.gastro.2017.04.044. Epub 2017 May 4.

    PubMed 28479377

  • Benchimol EI, Bernstein CN, Bitton A, Carroll MW, Singh H, Otley AR, Vutcovici M, El-Matary W, Nguyen GC, Griffiths AM, Mack DR, Jacobson K, Mojaverian N, Tanyingoh D, Cui Y, Nugent ZJ, Coulombe J, Targownik LE, Jones JL, Leddin D, Murthy SK, Kaplan GG. Trends in Epidemiology of Pediatric Inflammatory Bowel Disease in Canada: Distributed Network Analysis of Multiple Population-Based Provincial Health Administrative Databases. Am J Gastroenterol. 2017 Jul;112(7):1120-1134. doi: 10.1038/ajg.2017.97. Epub 2017 Apr 18.

    PubMed 28417994

  • El-Matary W, Abej E, Deora V, Singh H, Bernstein CN. Impact of Fecal Calprotectin Measurement on Decision-making in Children with Inflammatory Bowel Disease. Front Pediatr. 2017 Jan 25;5:7. doi: 10.3389/fped.2017.00007. eCollection 2017.

    PubMed 28180127

  • Jewel Samadder N, Valentine JF, Guthery S, Singh H, Bernstein CN, Wan Y, Wong J, Boucher K, Pappas L, Rowe K, Bronner M, Ulrich CM, Burt RW, Curtin K, Smith KR. Colorectal Cancer in Inflammatory Bowel Diseases: A Population-Based Study in Utah. Dig Dis Sci. 2017 Aug;62(8):2126-2132. doi: 10.1007/s10620-016-4435-4. Epub 2017 Jan 3.

    PubMed 28050782

  • Nguyen GC, Bernstein CN, Benchimol EI. Risk of Surgery and Mortality in Elderly-onset Inflammatory Bowel Disease: A Population-based Cohort Study. Inflamm Bowel Dis. 2017 Feb;23(2):218-223. doi: 10.1097/MIB.0000000000000993.

    PubMed 27997435

  • Marrie RA, Walker JR, Graff LA, Lix LM, Bolton JM, Nugent Z, Targownik LE, Bernstein CN; CIHR Team "Defining the burden and managing the effects of psychiatric comorbidity in chronic immunoinflammatory disease". Performance of administrative case definitions for depression and anxiety in inflammatory bowel disease. J Psychosom Res. 2016 Oct;89:107-13. doi: 10.1016/j.jpsychores.2016.08.014. Epub 2016 Sep 3.

    PubMed 27663119

  • Graff LA, Sexton KA, Walker JR, Clara I, Targownik LE, Bernstein CN. Validating a Measure of Patient Self-efficacy in Disease Self-management Using a Population-based IBD Cohort: The IBD Self-efficacy Scale. Inflamm Bowel Dis. 2016 Sep;22(9):2165-72. doi: 10.1097/MIB.0000000000000856.

    PubMed 27542132

  • Restall GJ, Simms AM, Walker JR, Graff LA, Sexton KA, Rogala L, Miller N, Haviva C, Targownik LE, Bernstein CN. Understanding Work Experiences of People with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2016 Jul;22(7):1688-97. doi: 10.1097/MIB.0000000000000826.

    PubMed 27271487

  • Bernstein CN, Garland A, Peschken CA, Hitchon CA, Chen H, Fransoo R, Marrie RA. Predictors of ICU Admission and Outcomes 1 Year Post-Admission in Persons with IBD: A Population-based Study. Inflamm Bowel Dis. 2015 Jun;21(6):1341-7. doi: 10.1097/MIB.0000000000000363.

    PubMed 25989339

  • Vagianos K, Clara I, Carr R, Graff LA, Walker JR, Targownik LE, Lix LM, Rogala L, Miller N, Bernstein CN. What Are Adults With Inflammatory Bowel Disease (IBD) Eating? A Closer Look at the Dietary Habits of a Population-Based Canadian IBD Cohort. JPEN J Parenter Enteral Nutr. 2016 Mar;40(3):405-11. doi: 10.1177/0148607114549254. Epub 2014 Sep 4.

    PubMed 25189173

  • Serrano Leon A, Amir Shaghaghi M, Yurkova N, Bernstein CN, El-Gabalawy H, Eck P. Single-nucleotide polymorphisms in SLC22A23 are associated with ulcerative colitis in a Canadian white cohort. Am J Clin Nutr. 2014 Jul;100(1):289-94. doi: 10.3945/ajcn.113.080549. Epub 2014 Apr 16.

    PubMed 24740203

  • Marrie RA, Garland A, Peschken CA, Hitchon CA, Chen H, Fransoo R, Bernstein CN. Increased incidence of critical illness among patients with inflammatory bowel disease: a population-based study. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2063-70.e1-4. doi: 10.1016/j.cgh.2014.03.033. Epub 2014 Apr 12.

    PubMed 24726908

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University of Manitoba.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genetic Associations (time frame: 2010 to 2016). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03262649, which also lists 60 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.

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