NCT05548166

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2020Dec 2026

Study Start

First participant enrolled

October 26, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

5.2 years

First QC Date

September 16, 2022

Last Update Submit

November 2, 2022

Conditions

Celiac Disease in ChildrenCeliac DiseasePatient-reported Outcome Measures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Qualitative interviews - for item generation

    24 months

  • Cognitive debriefing interviews - qualitative feedback on scale instructions, response options and items

    24 months

  • Expert survey data - qualitative feedback on scale instructions, response options and items

    24 months

Study Arms (3)

Pediatric Patients

Pediatric patients with celiac disease.

Other: Interview and scale development

Caregivers and parents

Caregivers and parents of pediatric patients with celiac disease

Other: Interview and scale development

Experts

Group of experts in pediatric celiac disease to provide feedback on scale development.

Other: Interview and scale development

Interventions

Interview and scale developmentOTHER

Interview and scale development

Caregivers and parentsExpertsPediatric Patients

Eligibility Criteria

Age4 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPatients of all genders are included in this study.
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study will include participants from the McMaster Children's Hospital Pediatric Celiac Disease Clinic and the Hospital for Sick Children (SickKids) Children's Celiac Clinic. Patients who have confirmed celiac disease (based on biopsy and/or serology) will be recruited to participant. Patients aged 1 to 8 years of age will participate in the interviews with their caregiver, whereas caregivers will participate on their own when their child is under the age of 8. Both genders will be recruited in patient and parent groups.

You may qualify if:

  • Patients diagnosed with celiac disease.
  • Pediatric patients (18 years and younger).
  • Ability to understand and communicate in the English language

You may not qualify if:

  • Patients who do not have celiac disease.
  • Non-pediatric patients (over 18).
  • Unable to understand and communicate in the English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

SickKids | The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 21, 2022

Study Start

October 26, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations

CA(2)