Celiac Disease in ChildrenNCT05548166
Development of CELIAC-Q KIDS: A Patient-Reported Outcome Measure for Pediatric Celiac Disease
An observational study of Celiac Disease in Children and Celiac Disease, run by McMaster University at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children, Celiac Disease, Patient-reported Outcome Measures
- What is being tested?
- Interview and scale development
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 26 Oct 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Patients diagnosed with celiac disease.
- Pediatric patients (18 years and younger).
- Ability to understand and communicate in the English language
Who cannot join
- Patients who do not have celiac disease.
- Non-pediatric patients (over 18).
- Unable to understand and communicate in the English language
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
SickKids | The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Phase 1 Protocol to Develop a Patient-reported Outcome Measure for Children and Adolescents With Celiac Disease: CELIAC-Q KIDS
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.
Read the detailed 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.
- Being tested
- Interview and scale development
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview and scale developmentOther
Interview and scale development
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Patients | Pediatric patients with celiac disease. Receives: Other: Interview and scale development | |
| Caregivers and parents | Caregivers and parents of pediatric patients with celiac disease Receives: Other: Interview and scale development | |
| Experts | Group of experts in pediatric celiac disease to provide feedback on scale development. Receives: Other: Interview and scale development |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 Months
Secondary outcomes (3)
Qualitative interviews - for item generation
Patient participants
Measured: 24 months
Cognitive debriefing interviews - qualitative feedback on scale instructions, response options and items
Patient participants
Measured: 24 months
Expert survey data - qualitative feedback on scale instructions, response options and items
Expert participant questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start26 Oct 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Canadian Celiac Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548166
- Sponsor's protocol ID
- 11126
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Protocol to Develop a Patient-reported Outcome Measure for Children and Adolescents With Celiac Disease: CELIAC-Q KIDS
- ClinicalTrials.gov ID
- NCT05548166
- Acronym / sponsor ID
- 11126
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Canadian Celiac Association
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients | – | Other: Interview and scale developmentPediatric patients with celiac disease. |
| Caregivers and parents | – | Other: Interview and scale developmentCaregivers and parents of pediatric patients with celiac disease |
| Experts | – | Other: Interview and scale developmentGroup of experts in pediatric celiac disease to provide feedback on scale development. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Patients diagnosed with celiac disease.
- Pediatric patients (18 years and younger).
- Ability to understand and communicate in the English language
Key exclusion criteria (3 listed)
- Patients who do not have celiac disease.
- Non-pediatric patients (over 18).
- Unable to understand and communicate in the English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview and scale developmentInterview and scale development | Other | Caregivers and parents, Experts, Pediatric Patients |
Primary outcome
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
Time frame: 48 Months
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
3 secondary outcomes
Qualitative interviews - for item generation
Time frame: 24 months
Cognitive debriefing interviews - qualitative feedback on scale instructions, response options and items
Time frame: 24 months
Expert survey data - qualitative feedback on scale instructions, response options and items
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
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Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
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Immune Responses to Gluten
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children and Celiac Disease, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 48 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.