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

Sponsor
Department of Plastic and Reconstructive Surgery (Other)
Overall Status
Recruiting
CT.gov ID
NCT05775679
Collaborator
Karolinska University Hospital (Other), Linköping Univeristy Hospital (Other), Umeå University Hospital (Other), Uppsala University Hospital (Other)
260
Enrollment
1
Location
82.5
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    260 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
    Actual Study Start Date :
    Feb 15, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    Test-retest reliability

    50 patients answer CLEFT-Q twice with 1-2 weeks in between.
    Secondary Nose Surgery

    50 patients answer CLEFT-Q before and 6 months after secondary nose surgery.
    Secondary Lip Surgery

    50 patients answer CLEFT-Q before and 6 months after secondary lip surgery.
    Jaw Surgery

    50 patients answer CLEFT-Q before and 1 year after jaw surgery.
    Secondary Speech Improving Surgery

    50 patients answer CLEFT-Q before and 1 year after secondary speech improving surgery.
    Health care professionals

    20 health care professionals will be interviewed about their experiences on working with CLEFT-Q.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Photograph [Before surgery and after 6 months or 1 year.]

      Photographs from before and after surgery

    2. Speech [Before surgery and after 1 year.]

      Recording of speech

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 29 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Skania University Hospital Malmö Skania Sweden

    Sponsors and Collaborators

    • Department of Plastic and Reconstructive Surgery
    • Karolinska University Hospital
    • Linköping Univeristy Hospital
    • Umeå University Hospital
    • Uppsala University Hospital

    Investigators

    • Principal Investigator: Mia Stiernman, MD PhD, Mia Stiernman

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Department of Plastic and Reconstructive Surgery
    ClinicalTrials.gov Identifier:
    NCT05775679
    Other Study ID Numbers:
    • 2021-06993-01
    First Posted:
    Mar 20, 2023
    Last Update Posted:
    Mar 20, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Department of Plastic and Reconstructive Surgery
    CLEFT-Q
    Psychometrics
    Test-retest reliability
    Interpretability
    Responsiveness
    Additional relevant MeSH terms:
    Cleft Lip

    Study Results

    No Results Posted as of Mar 20, 2023