Cleft Lip and PalateCLEFT-QSwePsycNCT05775679
Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
An observational study of Cleft Lip and Palate, run by Department of Plastic and Reconstructive Surgery at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- How many people
- 260 participants
- Where
- 1 siteSweden
- Study dates
- 15 Feb 2022to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Cleft lip and/or palate
- Planned secondary surgery of the nose, lips, jaw or to improve speech
- Can speak and read Swedish
Who cannot join
- Multiple surgeries at once
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skania University Hospital
Malmö, Skåne County
Mia Stiernman, MD PhD, +46737032606, mia.stiernman@med.lu.se
About this study
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:
- Are CLEFT-Q scores reliable over time?
- Can CLEFT-Q detect change following surgical treatment intervention?
- What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate?
- What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate?
- Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?
- What are the main expectations that patients express before a surgical intervention?
- How do patients perceive that the results after surgical interventions meet their expectations?
- Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?
- How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?
Read more
Participants will
- Fill out the questionnaire CLEFT-Q twice with a two-week space.
- Before and 1 year after an operation.
- 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
- Keywords
- CLEFT-Q, Psychometrics, Test-retest reliability, Interpretability, Responsiveness
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
CLEFT-Q change scores
CLEFT-Q is a questionnaire on health related quality of life specific to patients with cleft lip and palate
Measured: At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.
Secondary outcomes (2)
Photograph
Photographs from before and after surgery
Measured: Before surgery and after 6 months or 1 year.
Speech
Recording of speech
Measured: Before surgery and after 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start15 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Department of Plastic and Reconstructive Surgery
- Sponsor type
- Research network
- Collaborators
- Karolinska University Hospital, Linköping Univeristy Hospital, University Hospital, Umeå, Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Mia Stiernman, MD PhD, Principal investigator, Mia Stiernman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775679
- Sponsor's protocol ID
- 2021-06993-01
- Acronym
- CLEFT-QSwePsyc
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
- ClinicalTrials.gov ID
- NCT05775679
- Acronym / sponsor ID
- CLEFT-QSwePsyc / 2021-06993-01
- Conditions
- Cleft Lip and Palate
- Keywords
- CLEFT-Q, Psychometrics, Test-retest reliability, Interpretability, Responsiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Department of Plastic and Reconstructive SurgeryResearch network
- Collaborators
- Karolinska University Hospital, Linköping Univeristy Hospital, University Hospital, Umeå, Uppsala University Hospital
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are CLEFT-Q scores reliable over time?
- Can CLEFT-Q detect change following surgical treatment intervention?
- What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate?
- What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate?
- Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?
- What are the main expectations that patients express before a surgical intervention?
- How do patients perceive that the results after surgical interventions meet their expectations?
- Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?
- How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?
Participants will
- Fill out the questionnaire CLEFT-Q twice with a two-week space.
- Before and 1 year after an operation.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Cleft lip and/or palate
- Planned secondary surgery of the nose, lips, jaw or to improve speech
- Can speak and read Swedish
Key exclusion criteria (1 listed)
- Multiple surgeries at once
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Photograph
Time frame: Before surgery and after 6 months or 1 year.
Speech
Time frame: Before surgery and after 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mia Stiernman, MD PhD principal investigator
Mia Stiernman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Palate, run by Department of Plastic and Reconstructive Surgery at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mia Stiernman, MD PhD (+46737032606, mia.stiernman@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLEFT-Q change scores (time frame: At enrollment and after 1-2 weeks, or after 6 months, or after 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.