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

March 16, 2023 updated by: Department of Plastic and Reconstructive Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
    • Skania
      • Malmö, Skania, Sweden
        • Recruiting
        • Skania University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CLEFT-Q change scores
Time Frame: 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
At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Photograph
Time Frame: Before surgery and after 6 months or 1 year.
Photographs from before and after surgery
Before surgery and after 6 months or 1 year.
Speech
Time Frame: Before surgery and after 1 year.
Recording of speech
Before surgery and after 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Department of Plastic and Reconstructive Surgery

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska University Hospital
Uppsala University Hospital
Linköping Univeristy Hospital
Umeå University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mia Stiernman, MD PhD, Mia Stiernman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-06993-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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