[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498855":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":27,"centralContacts":32,"locations":37,"responsibleParty":53,"collaborators":55,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":80,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Department of Plastic and Reconstructive Surgery","NETWORK",[8,12,15,18,21,24],{"label":9,"type":10,"description":11,"interventionNames":10},"Test-retest reliability",null,"50 patients answer CLEFT-Q twice with 1-2 weeks in between.",{"label":13,"type":10,"description":14,"interventionNames":10},"Secondary Nose Surgery","50 patients answer CLEFT-Q before and 6 months after secondary nose surgery.",{"label":16,"type":10,"description":17,"interventionNames":10},"Secondary Lip Surgery","50 patients answer CLEFT-Q before and 6 months after secondary lip surgery.",{"label":19,"type":10,"description":20,"interventionNames":10},"Jaw Surgery","50 patients answer CLEFT-Q before and 1 year after jaw surgery.",{"label":22,"type":10,"description":23,"interventionNames":10},"Secondary Speech Improving Surgery","50 patients answer CLEFT-Q before and 1 year after secondary speech improving surgery.",{"label":25,"type":10,"description":26,"interventionNames":10},"Health care professionals","20 health care professionals will be interviewed about their experiences on working with CLEFT-Q.",[28],{"name":29,"affiliation":30,"role":31},"Mia Stiernman, MD PhD","Mia Stiernman","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":10,"email":36},"CONTACT","+46737032606","mia.stiernman@med.lu.se",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Skania University Hospital","RECRUITING","Malmö","Skåne County","Sweden","SE",{"type":46,"coordinates":47},"Point",[48,49],13.00073,55.60587,{"lat":49,"lon":48},[52],{"name":29,"role":34,"phone":35,"phoneExt":10,"email":36},{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[56,59,62,64],{"name":57,"class":58},"Karolinska University Hospital","OTHER",{"name":60,"class":61},"Linköping Univeristy Hospital","UNKNOWN",{"name":63,"class":58},"University Hospital, Umeå",{"name":65,"class":58},"Uppsala University Hospital","100498855","test-retest-reliability-responsiveness-and-interpretability-of-cleft-q-100498855",false,"NCT05775679","Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q","CLEFT-QSwePsyc","Inclusion Criteria:\n\n* Cleft lip and\u002For palate\n* Planned secondary surgery of the nose, lips, jaw or to improve speech\n* Can speak and read Swedish\n\nExclusion Criteria:\n\n* Multiple surgeries at once",true,"ALL","8 Years","29 Years",{"count":78,"type":79},260,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and\u002For palate. The main questions it aims to answer are:\n\n1. Are CLEFT-Q scores reliable over time?\n2. Can CLEFT-Q detect change following surgical treatment intervention?\n3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and\u002For palate?\n4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and\u002For palate?\n5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?\n6. What are the main expectations that patients express before a surgical intervention?\n7. How do patients perceive that the results after surgical interventions meet their expectations?\n8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?\n9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?\n\nParticipants will\n\n1. Fill out the questionnaire CLEFT-Q twice with a two-week space.\n2. Before and 1 year after an operation.\n3. Be interviewed about their experiences related to an operation or using CLEFT-Q.\n\nResearchers 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.",[84],"Cleft Lip and Palate",[86,87,9,88,89],"CLEFT-Q","Psychometrics","Interpretability","Responsiveness","2023-03-16",{"date":92,"type":93},"2023-03-20","ACTUAL",{"date":95,"type":93},"2022-02-15",{"date":97,"type":79},"2028-12-31",{"name":5,"class":6},1]