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

NCT03522623 | Unknown

• 1 other identifier: HS20851(H2017:189)
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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. 1.Determine the cost of care of children with IBD, incurred by caregivers,across Canada. Costs include:
2. 2.Determine the sociodemographic and disease characteristics associated with higher costs

Conditions

IBD

Keywords

colitis; costs; Crohn; IBD

Outcome Measures

Primary Outcomes (1)

• Costs of care of children with IBD incurred by caregivers

  Questionnaire: mean one month cost per patient in Canadian dollars

  24 months

Study Arms (1)

IBD

Children and families with IBD will be surveyed

Other: Non-interventional study

Interventions

Non-interventional study OTHER

Non-interventional study

IBD

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

• Non confirmed IBD

Sponsors & Collaborators

• University of Manitoba: lead
• University of Ottawa: collaborator
• University of Toronto: collaborator
• University of Alberta: collaborator
• University of Calgary: collaborator
• Dalhousie University: collaborator
• Provincial Health Services Authority British Columbia: collaborator

Study Sites (1)

Winnipeg Children's Hospital

Winnipeg, Manitoba, R3A 1S1, Canada

RECRUITING

Related Publications (1)

• El-Matary W, Witt J, Bernstein CN, Jacobson K, Mack D, Otley A, Walters TD, Huynh HQ, deBruyn J, Griffiths AM, Benchimol EI. Indirect and Out-of-Pocket Disease-associated Costs in Pediatric Inflammatory Bowel Disease: A Cross-sectional Analysis. J Pediatr Gastroenterol Nutr. 2022 Oct 1;75(4):466-472. doi: 10.1097/MPG.0000000000003545. Epub 2022 Jun 27.

  PMID: 35758424 DERIVED

MeSH Terms

Conditions

Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• WAEL EL-MATARY, MD

  Associate Professor, Section Head, Pediatric Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WAEL EL-MATARY, MD

CONTACT

2047871039; welmatary@HSC.MB.CA

Vini Deora, MSc

CONTACT

2047874956; vdoera@exchange.hsc.mb.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Section Head, Pediatric GI

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: May 11, 2018
• Study Start: November 1, 2017
• Primary Completion: November 7, 2019
• Study Completion: May 1, 2020
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

CA (1)