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Estimating Indirect and OOP Costs in Pediatric Inflammatory Bowel Disease: a National Study

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ClinicalTrials.gov Identifier: NCT03522623
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
University of Ottawa
University of Toronto
University of Alberta
University of Calgary
Dalhousie University
Provincial Health Services Authority
Information provided by (Responsible Party):
Wael El-Matary, University of Manitoba

Brief Summary:

inflammation of the gastrointestinal tract. A recent Canadian study from found that Canada has amongst highest incidence rates of childhood-onset IBD (10 per 100,000 for children <16y). In 2012, Crohn's and Colitis Canada estimated that direct medical costs of IBD in Canada were >$1 billion, and estimated indirect costs amounting to $1.8 billion. An American study demonstrated the direct costs of caring for children with IBD was double those for adults. Indirect health care costs in children with IBD have not been well-described. The Canadian Gastro-Intestinal Epidemiology Consortium (CanGIEC) is a pan-Canadian network of new and established IBD clinician-researchers and methodologists from 6 provinces experienced in the use of health administrative data. CanGIEC is evaluating variation in care of children with IBD, and will expand this research stream to assess direct and indirect cost of care. This will involve a collaboration with the CIHR/CHILD Foundation Canadian Children IBD Network (CIDsCaNN), which comprises an inception cohort of children diagnosed at all 12 pediatric IBD centres across Canada.

Hypothesis: Direct health costs are dominated by medication expenses (particularly biologics), with resulting variation within and across provinces in costs and out-of-pocket expenses to the families due to coverage disparity. Indirect costs include school and parental absenteeism, and productivity losses.

Aims:

  1. Determine the cost of care of children with IBD, incurred by caregivers,across Canada. Costs include:

    a Indirect costs - costs to the patient or family related to having the disease but not to direct health care.

    b. Out of pocket (OOP) - costs paid in cash or credit for health-related expenses not covered by the public health or private insurance systems.

  2. Determine the sociodemographic and disease characteristics associated with higher costs

Methods:

Population: Incident cases of IBD (<16y) over 12 months (est. enrollment 250-300).

Indirect and OOP disease-related costs will be determined with surveys conducted one year following diagnosis and every 6mo for 2y. These will be conducted querying families on the preceding 4 weeks including: school and work days missed, out-of-pocket expenses, distance travelled to appointments, medications expenses incurred, and disability benefits collected. Indirect costs will be calculated using the Human Capital Approach (gross income not earned due to disease).


Condition or disease Intervention/treatment
IBD Other: Non-interventional study

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Estimating Indirect and OOP Costs in Pediatric Inflammatory Bowel Disease: a National Study
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 7, 2019
Estimated Study Completion Date : May 1, 2020

Group/Cohort Intervention/treatment
IBD
Children and families with IBD will be surveyed
Other: Non-interventional study
Non-interventional study




Primary Outcome Measures :
  1. Costs of care of children with IBD incurred by caregivers [ Time Frame: 24 months ]
    Questionnaire: mean one month cost per patient in Canadian dollars



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Incident cases of pediatric IBD (<17y) in (CIDsCaNN) centres enrolled over a 12 month period (estimated enrollment 300-400 patients).
Criteria

Inclusion Criteria:

  • Incident cases of pediatric IBD (<17y) in (CIDsCaNN) centres enrolled over a 12 month period (estimated enrollment 300-400 patients).

Exclusion Criteria:

  • Non confirmed IBD

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): NCT03522623


Contacts
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Contact: WAEL EL-MATARY, MD 2047871039 welmatary@HSC.MB.CA
Contact: Vini Deora, MSc 2047874956 vdoera@exchange.hsc.mb.ca

Locations
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Canada, Manitoba
Winnipeg Children's Hospital Recruiting
Winnipeg, Manitoba, Canada, R3A 1S1
Contact: Wael El-Matary, MD         
Sponsors and Collaborators
University of Manitoba
University of Ottawa
University of Toronto
University of Alberta
University of Calgary
Dalhousie University
Provincial Health Services Authority
Investigators
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Principal Investigator: WAEL EL-MATARY, MD Associate Professor, Section Head, Pediatric Gastroenterology
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Responsible Party: Wael El-Matary, Associate Professor and Section Head, Pediatric GI, University of Manitoba
ClinicalTrials.gov Identifier: NCT03522623    
Other Study ID Numbers: HS20851(H2017:189)
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wael El-Matary, University of Manitoba:
colitis
costs
Crohn
IBD
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis