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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05775679

Acronym

CLEFT-QSwePsyc

Enrollment

260

Registered

2023-03-20

Start date

2022-02-15

Completion date

2028-12-31

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Keywords

CLEFT-Q, Psychometrics, Test-retest reliability, Interpretability, Responsiveness

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 29 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Photograph	Before surgery and after 6 months or 1 year.	Photographs from before and after surgery
Speech	Before surgery and after 1 year.	Recording of speech

Countries

Sweden

Contacts

Primary ContactMia Stiernman, MD PhD

mia.stiernman@med.lu.se+46737032606

Outcome results