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

Recruiting

• Conditions: Cleft Lip and Palate

• Registration Number: NCT05775679
• Lead Sponsor: Department of Plastic and Reconstructive Surgery

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-20
• Last Update Posted: 2023-03-20
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CLEFT-Q change scores	At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.	CLEFT-Q is a questionnaire on health related quality of life specific to patients with cleft lip and palate

Secondary Outcome Measures

Name	Time	Method
Speech	Before surgery and after 1 year.	Recording of speech
Photograph	Before surgery and after 6 months or 1 year.	Photographs from before and after surgery

Trial Locations

Locations (1)

Skania University Hospital; 🇸🇪 Malmö, Skania, Sweden