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

Cleft Lip and Palate Clinical Trial

— CLEFT-QSwePsyc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05775679
• Other study ID #: 2021-06993-01
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2023
• Source: DeptPlastic
• Contact: Mia Stiernman, MD PhD
• Phone: +46737032606
• Email: mia.stiernman[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Locations

Country	Name	City	State
Sweden	Skania University Hospital	Malmö	Skania

Sponsors (5)

Lead Sponsor	Collaborator
Department of Plastic and Reconstructive Surgery	Karolinska University Hospital, Linköping Univeristy Hospital, Umeå University Hospital, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CLEFT-Q change scores	CLEFT-Q is a questionnaire on health related quality of life specific to patients with cleft lip and palate	At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.
Secondary	Photograph	Photographs from before and after surgery	Before surgery and after 6 months or 1 year.
Secondary	Speech	Recording of speech	Before surgery and after 1 year.