Pediatric Celiac Disease Index: CELIAC-Q KIDS

• Sponsor: McMaster University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05548166
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 74.2
• Patients Per Site: 50
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Celiac disease is very common in Canada and is found in 1% of our population. Pediatricians, nurses and registered dietitians that care for children with celiac disease do not know the outcomes that are most important to children and their families. Understanding the ongoing symptoms of celiac disease in children will help us to assess important outcomes in celiac disease and improve how we take care of these patients.

We are currently developing a patient-reported outcome measure, the Pediatric Celiac Symptom Index, that will guide doctors, nurses and registered dietitians as to the questions to ask about how children with celiac disease physically feel. Similar to the patient-reported outcome measures that exist for adults with celiac disease, our patient-reported outcome measure will be distributed and made available worldwide which can have a large impact in both research and clinical care for children with celiac disease.

A patient-reported outcome measure requires expert training in a specific type of research that uses one-on-one interviews to determine what is most important to children with celiac disease and their families and then combines the results of many interviews to create a score.

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease in Children; Celiac Disease; Patient-reported Outcome Measures	Other: Interview and scale development

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Phase 1 Protocol to Develop a Patient-reported Outcome Measure for Children With Celiac Disease: CELIAC-Q KIDS
• Actual Study Start Date: Oct 26, 2020
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Pediatric Patients Pediatric patients with celiac disease.	Other: Interview and scale development; Interview and scale development
Caregivers and parents Caregivers and parents of pediatric patients with celiac disease.	Other: Interview and scale development; Interview and scale development
Experts Group of experts to provide feedback on scale development.	Other: Interview and scale development; Interview and scale development

Outcome Measures

Primary Outcome Measures

1. Patient-reported outcome measure [48 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Positive diagnosis of celiac disease.

• Pediatric patients (under 18).

Exclusion Criteria:

• Non-pediatric patients (over 18).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster Children's Hospital	Hamilton	Ontario	Canada	L8N 3Z5
2	SickKids | The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

• McMaster University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT05548166
• Other Study ID Numbers: 11126
• First Posted: Sep 21, 2022
• Last Update Posted: Sep 21, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Celiac Disease

Study Results

No Results Posted as of Sep 21, 2022