Evaluating the CLEFT-Q questionnaire for patients with cleft lip and palate
Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
This study is testing a questionnaire called CLEFT-Q to see how well it works for people with cleft lip and palate in tracking their health and changes after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 8 Years to 29 Years |
| Sex | All |
| Sponsor | Department of Plastic and Reconstructive Surgery Research network |
| Locations | 1 site (Malmö, Skåne County) |
| Trial ID | NCT05775679 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the reliability and responsiveness of the CLEFT-Q questionnaire in patients with cleft lip and/or palate. It will evaluate whether CLEFT-Q scores remain consistent over time and can detect changes following surgical interventions. Additionally, the study seeks to establish normative data for CLEFT-Q in a control population and identify the Minimal Clinically Important Change across different subpopulations. The research will also explore patient expectations and perceptions regarding surgical outcomes and the impact of CLEFT-Q on clinical decision-making.
Who should consider this trial
Good fit: Ideal candidates include individuals with cleft lip and/or palate who are planning secondary surgeries and can communicate in Swedish.
Not a fit: Patients undergoing multiple surgeries at once may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the assessment of patient-reported outcomes in cleft lip and palate surgeries, leading to improved patient care.
How similar studies have performed: While the specific application of CLEFT-Q is being evaluated here, similar psychometric assessments have shown promise in other patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cleft lip and/or palate * Planned secondary surgery of the nose, lips, jaw or to improve speech * Can speak and read Swedish Exclusion Criteria: * Multiple surgeries at once
Where this trial is running
Malmö, Skåne County
- Skania University Hospital — Malmö, Skåne County, Sweden (Recruiting)
Study contacts
- Principal investigator: Mia Stiernman, MD PhD — Mia Stiernman
- Study coordinator: Mia Stiernman, MD PhD
- Email: mia.stiernman@med.lu.se
- Phone: +46737032606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.