Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q
NCT ID: NCT05775679
Last Updated: 2023-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
260 participants
OBSERVATIONAL
2022-02-15
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Test-retest reliability
50 patients answer CLEFT-Q twice with 1-2 weeks in between.
No interventions assigned to this group
Secondary Nose Surgery
50 patients answer CLEFT-Q before and 6 months after secondary nose surgery.
No interventions assigned to this group
Secondary Lip Surgery
50 patients answer CLEFT-Q before and 6 months after secondary lip surgery.
No interventions assigned to this group
Jaw Surgery
50 patients answer CLEFT-Q before and 1 year after jaw surgery.
No interventions assigned to this group
Secondary Speech Improving Surgery
50 patients answer CLEFT-Q before and 1 year after secondary speech improving surgery.
No interventions assigned to this group
Health care professionals
20 health care professionals will be interviewed about their experiences on working with CLEFT-Q.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Planned secondary surgery of the nose, lips, jaw or to improve speech
* Can speak and read Swedish
Exclusion Criteria
8 Years
29 Years
ALL
Yes
Sponsors
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Karolinska University Hospital
OTHER
Linköping Univeristy Hospital
UNKNOWN
Umeå University Hospital
UNKNOWN
Uppsala University Hospital
OTHER
Department of Plastic and Reconstructive Surgery
NETWORK
Responsible Party
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Principal Investigators
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Mia Stiernman, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Mia Stiernman
Locations
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Skania University Hospital
Malmo, Skåne County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-06993-01
Identifier Type: -
Identifier Source: org_study_id
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