MedTrace Logo

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

NCT05775679 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2023-03-20

No results posted yet for this study

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.

Conditions

  • Cleft Lip and Palate

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Linköping Univeristy Hospital

    collaborator UNKNOWN

  • Umeå University Hospital

    collaborator UNKNOWN

  • Uppsala University Hospital

    collaborator OTHER

  • Department of Plastic and Reconstructive Surgery

    lead NETWORK

Principal Investigators

  • Mia Stiernman, MD PhD · Mia Stiernman

Eligibility

Min Age
8 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05775679 on ClinicalTrials.gov