Actively Recruiting
Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
Led by Department of Plastic and Reconstructive Surgery · Updated on 2023-03-20
260
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
Sponsors
D
Department of Plastic and Reconstructive Surgery
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and/or palate. The main questions it aims to answer are: 1. Are CLEFT-Q scores reliable over time? 2. Can CLEFT-Q detect change following surgical treatment intervention? 3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate? 4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate? 5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention? 6. What are the main expectations that patients express before a surgical intervention? 7. How do patients perceive that the results after surgical interventions meet their expectations? 8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q? 9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes? Participants will 1. Fill out the questionnaire CLEFT-Q twice with a two-week space. 2. Before and 1 year after an operation. 3. Be interviewed about their experiences related to an operation or using CLEFT-Q. Researchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.
CONDITIONS
Official Title
Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has cleft lip and/or palate
- Planned for secondary surgery of the nose, lips, jaw, or to improve speech
- Can speak and read Swedish
You will not qualify if you...
- Undergoing multiple surgeries at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Skania University Hospital
Malmö, Skåne County, Sweden
Actively Recruiting
Research Team
M
Mia Stiernman, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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