[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631289":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":78,"studyPopulation":78,"armGroups":81,"interventions":91,"overallOfficials":78,"centralContacts":102,"locations":108,"responsibleParty":143,"collaborators":78,"id":147,"slug":78,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":78,"eligibilityCriteria":151,"healthyVolunteers":148,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":78,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":169,"whyStopped":78,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":55},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Observable efforts of collaboration to align care and life, with and without using the tool.","Qualitative coding of observations","1 month from enrollment to the consultation",{"measure":14,"description":15,"timeFrame":16},"Perceived and unobservable efforts to align care and life.","Qualitative coding","2 months from enrollment into the study to the video stimulated interview",{"measure":18,"description":19,"timeFrame":20},"Perceived alignment of care plan and life.","Young adults \\& clinicians: Open-ended question: \"why does your care plan make sense?\"","4 months from enrollment to filling out the last questionnaire",[22,26,29,31,34,37,40,44,48,51],{"measure":23,"description":24,"timeFrame":25},"Variety and quality of themes discussed","Quantitative coding of observations, self-developed","1 month from enrollment to consultation",{"measure":27,"description":28,"timeFrame":25},"Collaborative care plan design","SDMo (reported on 1-10 scale) with higher scores suggesting more collaborative behaviours",{"measure":30,"description":24,"timeFrame":12},"Fidelity of the use of the Making Care Fit tool",{"measure":32,"description":33,"timeFrame":25},"Unhurried conversations","Unhurried Collaboration Assessment Tool (UCAT), 37 items to be scored on a 1-5 scale.",{"measure":35,"description":36,"timeFrame":20},"Perceived treatment burden, and acceptability of this burden.","Young adults: Treatment Burden Questionnaire (TBQ), 15 items to be scored on a 0-10 scale; 1 item on acceptability of burden.",{"measure":38,"description":39,"timeFrame":20},"Perceived diabetes distress","Young adults: Diabetes distress scale (DDS) screening instrument, 2 items to be scored on a 1-6 scale.",{"measure":41,"description":42,"timeFrame":43},"Self-reported fidelity of using the Making Care Fit tool outside of the clinical encounter","Young adults \\& clinicians: 3 items about fidelity and and acceptability","1 month from enrollment to concluding the consultation",{"measure":45,"description":46,"timeFrame":47},"Perceived clinical empathy","Young adults: Consultation And Relational Empathy (CARE) measure, 10 items to be scored on a 1-5 scale.","1 month from enrollment to after the consultation",{"measure":49,"description":15,"timeFrame":50},"Written information by patient in making care fit tool","1 month from enrollment to having the consultation",{"measure":52,"description":53,"timeFrame":54},"patient involvement","OPTION12 (reported on 0-100 scale) with a higher score being more patient involvement","1 month after enrollment during the clinical consultation",[56,59,63,67,70],{"measure":57,"description":58,"timeFrame":25},"Consultation characteristics","Encounter duration, diabetes clinic, consultation type (in-person or digital)",{"measure":60,"description":61,"timeFrame":62},"Diabetes-specific characteristics","8 items (self-developed): Treatment regime, year of diagnosis, events of ketoacidosis and hypoglycaemia, HbA1c.","4 months from enrollment to last questionnaire filled out",{"measure":64,"description":65,"timeFrame":66},"Consultation characteristic","1 item (self-developed: Duration of patient\u002Fclinician relationship in years","4 months from enrollment to last questionnaire",{"measure":68,"description":69,"timeFrame":25},"Work-related characteristics","2 items (self-developed): Clinicians' years worked, clinical background",{"measure":71,"description":72,"timeFrame":66},"Participant characteristics","Young adults: 7 items (self-developed): Age, gender, household situation, socioeconomic status, comorbidity, level of education13\n\nClinicians: 2 items (self-developed):\n\nAge, gender.",{"allocation":74,"interventionModel":75,"interventionModelDescription":76,"primaryPurpose":77,"observationalModel":78,"timePerspective":78,"maskingInfo":79},"NON_RANDOMIZED","PARALLEL","This is a multi-center clinical study using a mixed methods parallel group design. Young adults with type 1 diabetes are assigned to either usual care or care supported by the finalized Making Care Fit tool (MCF tool). Clinical encounters are observed and assessed to compare collaborative efforts to align care with daily life between the two groups.","HEALTH_SERVICES_RESEARCH",null,{"masking":80,"maskingDescription":78,"whoMasked":78},"NONE",[82,86],{"label":83,"type":6,"description":78,"interventionNames":84},"Care as usual",[85],"Other: Care as usual",{"label":87,"type":88,"description":78,"interventionNames":89},"Make Care Fit tool","EXPERIMENTAL",[90],"Behavioral: Making Care Fit tool",[92,99],{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"BEHAVIORAL","Making Care Fit tool","A web-based tool designed to help young adults with type 1 diabetes prepare for care plan design during their clinical encounter by structuring and prioritizing their experiences and efforts in making care fit.",[87],[98],"MCF tool",{"type":6,"name":83,"description":100,"armGroupLabels":101,"otherNames":78},"Participants receive standard diabetes care at their clinic. Clinical encounters are observed and assessed to compare collaborative efforts with those in the Making Care Fit Tool arm.",[83],[103],{"name":104,"role":105,"phone":106,"phoneExt":78,"email":107},"Marleen Kunneman, PhD","CONTACT","0715263967","Kunneman@lumc.nl",[109,129],{"facility":5,"status":78,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"Leiden","South Holland","2333ZA","Netherlands","NL",{"type":116,"coordinates":117},"Point",[118,119],4.49306,52.15833,{"lat":119,"lon":118},[122,126],{"name":123,"role":105,"phone":124,"phoneExt":78,"email":125},"Anka van Gastel, MSc","+31625027266","Ankavangastel@lumc.nl",{"name":127,"role":105,"phone":78,"phoneExt":78,"email":128},"Eelco de Koning, MD, Prof","e.j.p.de_koning@lumc.nl",{"facility":130,"status":78,"city":131,"state":111,"zip":132,"country":113,"countryCode":114,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Diabeter","Rotterdam","3011TA",{"type":116,"coordinates":134},[135,136],4.47917,51.9225,{"lat":136,"lon":135},[139,140],{"name":123,"role":105,"phone":124,"phoneExt":78,"email":125},{"name":141,"role":105,"phone":78,"phoneExt":78,"email":142},"Christine Fransman","c.fransman@diabeter.nl",{"type":144,"investigatorFullName":145,"investigatorTitle":146,"investigatorAffiliation":5,"oldNameTitle":78,"oldOrganization":78},"PRINCIPAL_INVESTIGATOR","Marleen Kunneman","Principal Investigator","100631289",false,"NCT07498738","Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions","Inclusion Criteria:\n\n* Young adults (age 18-30)\n* with ≥1 year since the diagnosis of type 1 diabetes\n* receiving ongoing treatment at participating diabetes clinics (Leiden university medical center (LUMC), Diabeter),\n* able to speak and read Dutch\n* able to provide informed consent for study participation\n\nExclusion Criteria:\n\n* People who do not fit the participant requirements\n* People who cannot give consent themselves (who are incapacitated)","ALL","18 Years","30 Years",{"count":156,"type":157},60,"ESTIMATED","INTERVENTIONAL",[160],"NA","The goal of this clinical study is to assess differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool among young adults with type 1 diabetes and their clinicians.\n\nThe main question it aims to answer is:\n\nWhat are the differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool?\n\nResearchers will compare clinical encounters in usual care with encounters supported by the Making Care Fit tool to examine differences in collaborative efforts to align care and daily life.\n\nParticipants will:\n\n* Take part in an observed clinical encounter with their clinician\n* Participate in a post-encounter video-stimulated interview reflecting on the consultation\n* Complete questionnaires about their experiences of the consultation",[163],"Type 1 Diabetes",[165,166,167,168],"Make Care Fit","young adults","type 1 diabetes","qualitative research","NOT_YET_RECRUITING","2026-03-23",{"date":172,"type":173},"2026-03-27","ACTUAL",{"date":175,"type":157},"2026-03-13",{"date":177,"type":157},"2026-10-30",{"name":5,"class":6},2]