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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-29
SponsorDepartment of Plastic and Reconstructive Surgery

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Cleft lip and/or palate

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

Can speak and read Swedish

Disqualifiers

Multiple surgeries at once

Trial population

\- Patients with cleft lip and/or palate who have been operated as infants and opt for secondary surgery to improve appearance, occlusion or speech.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

260 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: Test-retest reliability
Group B: Secondary Nose Surgery
Group C: Secondary Lip Surgery
Group D: Jaw Surgery
Group E: Secondary Speech Improving Surgery
Group F: Health care professionals

Trial outcomes

Primary outcomes

1

CLEFT-Q change scores

CLEFT-Q is a questionnaire on health related quality of life specific to patients with cleft lip and palate

Time frame
At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.

Secondary outcomes

1

Photograph

Photographs from before and after surgery

Time frame
Before surgery and after 6 months or 1 year.
2

Speech

Recording of speech

Time frame
Before surgery and after 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Department of Plastic and Reconstructive Surgery

Lead sponsor

Karolinska University Hospital

Collaborator

Linköping Univeristy Hospital

Collaborator

University Hospital, Umeå

Collaborator

Uppsala University Hospital

Collaborator