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RecruitingNCT05775679CLEFT-QSwePsycUpdated Mar 20, 2023

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

An observational study in Cleft Lip and Palate, sponsored by Department of Plastic and Reconstructive Surgery. Recruiting at 1 site in Sweden. Open to participants aged 8 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-20.

Sponsored by Department of Plastic and Reconstructive Surgery · Observational

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
260
Ages
8 Years to 29 Years
Sex
All
01

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.

02

Conditions studied

  • Cleft Lip and Palate

Browse trials for

Keywords

  • CLEFT-Q
  • Psychometrics
  • Test-retest reliability
  • Interpretability
  • Responsiveness
03

In context

Cleft Lip

168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.

This study's planned enrollment of 260 is above the median of 100 across 49 observational studies indexed under Cleft Lip.

Browse Cleft Lip studies →

Lead sponsor

This is the only study on the registry with Department of Plastic and Reconstructive Surgery as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Multiple surgeries at once
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
260 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

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.

07

Study locations

1 of 1 sites recruiting
  • Skania University Hospital
    Malmö, Skania, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2022 (actual). Primary completion is estimated for Dec 2026, 58 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2023
First posted
Mar 20, 2023
StartActual
Feb 15, 2022
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2028
Last update
Mar 20, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05775679
Lead sponsor
Department of Plastic and Reconstructive Surgery
Collaborators
Karolinska University Hospital, Linköping Univeristy Hospital, Umeå University Hospital, Uppsala University Hospital
Responsible party
Sponsor
First posted
Mar 20, 2023
Start date
Feb 15, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Mar 20, 2023

Study contacts

Mia Stiernman, MD PhD
Contact
mia.stiernman@med.lu.se
+46737032606
Mia Stiernman, MD PhD
principal investigator · Mia Stiernman

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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