[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571722":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":41,"centralContacts":45,"locations":50,"responsibleParty":80,"collaborators":83,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":10,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":10,"enrollmentInfo":96,"targetDuration":10,"studyType":99,"phases":10,"briefSummary":100,"conditions":101,"keywords":10,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14,18,22,26,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Children with spina bifida",null,"• Male or female aged 8 -12 years with spina bifida",[13],"Other: QUALAS survey",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group children","• Male or females aged 8 -12 years without spina bifida",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Teenagers with spina bifida","• Males or female aged 13 - 17 years with spina bifida",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Control group teenagers","• Males or females aged 13 - 17 years without spina bifida",[13],{"label":27,"type":10,"description":27,"interventionNames":28},"Adults with spina bifida",[13],{"label":30,"type":10,"description":31,"interventionNames":32},"Control group adults","Adults without spina bifida",[13],[34],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"QUALAS survey","Participants will be asked to complete the surveys at one (controls) and two (patients) timepoints.",[27,9,30,15,23,19],[39,40],"KIDSCREEN survey for children and teenagers","World Health Organization Quality of Life instrument (WHOQOL-BREF) and (International Consultation on Incontinence Questionnaire) ICIQ for adults",[42],{"name":43,"affiliation":5,"role":44},"Lisette 't Hoen, MD, PhD","PRINCIPAL_INVESTIGATOR",[46],{"name":43,"role":47,"phone":48,"phoneExt":10,"email":49},"CONTACT","0031107030073","l.thoen@erasmusmc.nl",[51,68],{"facility":52,"status":53,"city":54,"state":10,"zip":10,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"UMCG","NOT_YET_RECRUITING","Groningen","Netherlands","NL",{"type":58,"coordinates":59},"Point",[60,61],6.56667,53.21917,{"lat":61,"lon":60},[64],{"name":65,"role":47,"phone":66,"phoneExt":10,"email":67},"Rianne L.M. Lammers","0031503612167","rianne_lammers@hotmail.com",{"facility":69,"status":70,"city":71,"state":10,"zip":72,"country":55,"countryCode":56,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Erasmus MC","RECRUITING","Rotterdam","3015 GD",{"type":58,"coordinates":74},[75,76],4.47917,51.9225,{"lat":76,"lon":75},[79],{"name":43,"role":47,"phone":48,"phoneExt":10,"email":49},{"type":44,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Lisette 't Hoen","Principal Investigator",[84],{"name":85,"class":6},"University Medical Center Groningen","100571722","qualas-validation-in-dutch-100571722",false,"NCT06723951","QUALAS Validation in Dutch","Validation of the Quality of Life Assessment in Spina Bifida for Children and Adolescents in Dutch","Inclusion Criteria:\n\nPatient group:\n\n* Male or female patients aged 8 -12 years (QUALAS-C)\n* Male or female patients aged 13 - 17 years (QUALAS-T)\n* Adult patients (QUALAS-A)\n* Has spina bifida\n* Adult or child and at least one parent fluent in the Dutch language\n* Signed informed consent\n\nControl group:\n\n* Male or female children aged 8 -12 years (QUALAS-C)\n* Male or female adolescents aged 13 - 17 years (QUALAS-T)\n* Adults (QUALAS-A)\n* Has no spina bifida\n* Adult or child and at least one parent fluent in the Dutch language\n* Signed informed consent\n\nExclusion Criteria:\n\n* Has a neurogenic disease other than spina bifida\n* Has had surgery in the last month",true,"ALL","8 Years",{"count":97,"type":98},300,"ESTIMATED","OBSERVATIONAL","Rationale Patients with spina bifida often experience a decreased quality of life compared to patients without spina bifida. The Quality of Life Assessment for Spina Bifida (QUALAS) is a validated questionnaire to assess the quality of life in children, teenagers and adults with spina bifida, accounting for specific factors, such as bladder and bowel dysfunction. This questionnaire enables us to assess the current spina bifida related quality of life and identify if bladder and bowel dysfunction is of influence.\n\nObjective(s) To validate the Quality of Life Assessment for Spina Bifida in Children, Teenagers and Adults in Dutch.\n\nStudy type A multicenter prospective validation cohort study.\n\nStudy population Children aged 8 - 17 years and adults who are diagnosed with spina bifida. As a control group children aged 8 - 17 years and adults without spina bifida will be approached at the Ear-Nose-Throat (ENT) and paediatric clinics.\n\nMethods The main study parameter is the validation of the Dutch version of the questionnaire. Patients with spina bifida are asked to fill out the QUALAS at two time-points. They are also asked to fill out an extra questionnaire at two time-points, in order to validate the QUALAS. Children and adults in the control groups are asked to fill out the two questionnaires only once.\n\nBurden and risks No (extra) outpatient visit is required. The questions in the questionnaires are similar to the medical history during an outpatient visit. The burden is therefore minimal for these patients. Participation in this study will not influence patient treatment.\n\nRecruitment and consent Parents of children and children and adults who meet the inclusion criteria and none of the exclusion criteria will be informed orally about this study by their treating urologist during a regular visit. A patient information and consent form will be handed over to the parents and children over eight years of age and adults. Parents of children and children and adults at the ENT clinic will be approached by the local urologist for participation for this study. If they are willing to participate they will be asked to sign informed consent and fill out the questionnaire.",[102],"Spina Bifida","2024-12-09",{"date":105,"type":106},"2024-12-12","ACTUAL",{"date":103,"type":98},{"date":109,"type":98},"2025-03-31",{"name":5,"class":6},2]