NCT05775679

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. 1.Are CLEFT-Q scores reliable over time?
  2. 2.Can CLEFT-Q detect change following surgical treatment intervention?
  3. 3.What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate?
  4. 4.What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate?
  5. 5.Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?
  6. 6.What are the main expectations that patients express before a surgical intervention?
  7. 7.How do patients perceive that the results after surgical interventions meet their expectations?
  8. 8.Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?
  9. 9.How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?
  10. 10.Fill out the questionnaire CLEFT-Q twice with a two-week space.
  11. 11.Before and 1 year after an operation.
  12. 12.Be interviewed about their experiences related to an operation or using CLEFT-Q.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Feb 2022Dec 2028

Study Start

First participant enrolled

February 15, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

4.9 years

First QC Date

March 6, 2023

Last Update Submit

March 16, 2023

Conditions

Cleft Lip and Palate

Keywords

CLEFT-QPsychometricsTest-retest reliabilityInterpretabilityResponsiveness

Outcome Measures

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

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

Secondary Outcomes (2)

  • Photograph

    Before surgery and after 6 months or 1 year.

  • Speech

    Before surgery and after 1 year.

Study Arms (6)

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.

Eligibility Criteria

Age8 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • Cleft lip and/or palate
  • Planned secondary surgery of the nose, lips, jaw or to improve speech
  • Can speak and read Swedish

You may not qualify if:

  • Multiple surgeries at once

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skania University Hospital

Malmo, Skåne County, Sweden

RECRUITING

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mia Stiernman, MD PhD

    Mia Stiernman

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mia Stiernman, MD PhD

CONTACT

+46737032606mia.stiernman@med.lu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 20, 2023

Study Start

February 15, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

SE(1)