Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 29
Healthy Volunteers: t
View:

• Cleft lip and/or palate

• Planned secondary surgery of the nose, lips, jaw or to improve speech

• Can speak and read Swedish

Locations
Other Locations
Sweden
Skania University Hospital
RECRUITING
Malmo
Contact Information
Primary
Mia Stiernman, MD PhD
mia.stiernman@med.lu.se
+46737032606
Time Frame
Start Date: 2022-02-15
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 260
Treatments
Test-retest reliability
50 patients answer CLEFT-Q twice with 1-2 weeks in between.
Secondary Nose Surgery
50 patients answer CLEFT-Q before and 6 months after secondary nose surgery.
Secondary Lip Surgery
50 patients answer CLEFT-Q before and 6 months after secondary lip surgery.
Jaw Surgery
50 patients answer CLEFT-Q before and 1 year after jaw surgery.
Secondary Speech Improving Surgery
50 patients answer CLEFT-Q before and 1 year after secondary speech improving surgery.
Health care professionals
20 health care professionals will be interviewed about their experiences on working with CLEFT-Q.
Related Therapeutic Areas
Sponsors
Collaborators: Umeå University Hospital, Karolinska University Hospital, Uppsala University Hospital, Linköping Univeristy Hospital
Leads: Department of Plastic and Reconstructive Surgery

This content was sourced from clinicaltrials.gov