Development of CELIAC-Q KIDS: A Patient-Reported Outcome Measure for Pediatric Celiac Disease
NCT ID: NCT05548166
Last Updated: 2022-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2020-10-26
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Pediatric Patients
Pediatric patients with celiac disease.
Interview and scale development
Interview and scale development
Caregivers and parents
Caregivers and parents of pediatric patients with celiac disease
Interview and scale development
Interview and scale development
Experts
Group of experts in pediatric celiac disease to provide feedback on scale development.
Interview and scale development
Interview and scale development
Interventions
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Interview and scale development
Interview and scale development
Eligibility Criteria
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Inclusion Criteria
* Pediatric patients (18 years and younger).
* Ability to understand and communicate in the English language
Exclusion Criteria
* Non-pediatric patients (over 18).
* Unable to understand and communicate in the English language
4 Years
17 Years
ALL
Yes
Sponsors
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The Hospital for Sick Children
OTHER
Canadian Celiac Association
UNKNOWN
McMaster University
OTHER
Responsible Party
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Locations
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McMaster Children's Hospital
Hamilton, Ontario, Canada
SickKids | The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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11126
Identifier Type: -
Identifier Source: org_study_id
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