Development of CELIAC-Q KIDS: A Patient-Reported Outcome Measure for Pediatric Celiac Disease

Celiac Disease Clinical Trial

Official title:

Phase 1 Protocol to Develop a Patient-reported Outcome Measure for Children and Adolescents With Celiac Disease: CELIAC-Q KIDS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05548166
• Other study ID #: 11126
• Status: Active, not recruiting
• Start date: October 26, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A multicentre, prospective observational study to develop the CELIAC-Q KIDS patient reported outcome measure for children and adolescents with celiac disease. The CELIAC- Q KIDS will contain a comprehensive set of independently functioning scales designed to measure outcomes that matter to children with celiac disease, as well as scales to measure patients experience with the gluten-free diet.

Description:

The study will be conducted in three stages:

Stage I - Conceptual framework development: A scoping review will be carried out to map initial concepts that have been measured by patient report in pediatric patients with celiac disease. Findings will be used to develop a preliminary conceptual framework.

Stage II - Item generation: Approximately 20 interviews will be conducted with children and adolescents with celiac disease and their caregivers to capture their experiences including quality of life, symptom experience, and other relevant themes that may emerge. The interviews will be audio recorded and transcribed verbatim. The qualitative data will be analyzed thematically, and key quotes extracted which will be used to create a draft item list. Interviews will be conducted either in person or virtually depending on patient preference. The data from Stage I will be used to develop a preliminary version of the CELIAC-Q KIDS patient-reported outcome measure.

Stage II - Scale refinement:

The CELIAC-Q KIDS scales will be refined through multiple rounds of cognitive debriefing interviews using the "think aloud method." During each interview round, approximately 7 children and adolescents with celiac disease will be interviewed to determine if patients understand the instructions, response options and items of the CELIAC-Q KIDS instrument and to identify missing content. Interviews will take place in a series of rounds to allow time to make changes to the instrument and then obtain feedback on those changes until data saturation is achieved.

Between rounds of cognitive debriefing interviews, the CELIAC-Q KIDS will be shown to experts for feedback. A multidisciplinary, international group of approximately 10 healthcare providers who care for children and adolescents with celiac disease will be surveyed to determine if healthcare providers feel there are any items missing from the patient-reported outcome measure, if any items are not relevant and to provide feedback on the instructions and response options. Once again, feedback provided by the experts will be used to revise the CELIAC-Q KIDS scales.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with celiac disease.

• Pediatric patients (18 years and younger).

• Ability to understand and communicate in the English language

Exclusion Criteria:

• Patients who do not have celiac disease.

• Non-pediatric patients (over 18).

• Unable to understand and communicate in the English language

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children

Intervention

Other:
• Interview and scale development
Interview and scale development

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	SickKids | The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Celiac Association, The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of the patient-reported outcome measure: Consensus on items that will comprise the newly developed disease-specific patient-reported outcome measure for pediatric celiac disease	Development of the CELIAC-Q KIDS scales: qualitative interview and survey-based data will be analyzed qualitatively to develop and refine the items that comprise the scales	48 Months
Secondary	Qualitative interviews - for item generation	Patient participants	24 months
Secondary	Cognitive debriefing interviews - qualitative feedback on scale instructions, response options and items	Patient participants	24 months
Secondary	Expert survey data - qualitative feedback on scale instructions, response options and items	Expert participant questionnaire	24 months