[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658782":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":42,"studyPopulation":43,"armGroups":31,"interventions":44,"overallOfficials":48,"centralContacts":52,"locations":59,"responsibleParty":105,"collaborators":31,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":31,"enrollmentInfo":116,"targetDuration":31,"studyType":119,"phases":31,"briefSummary":120,"conditions":121,"keywords":126,"overallStatus":131,"whyStopped":31,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"The University of Queensland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"A Reach of 50% of eligible patients initiated on SGLT2i therapy","Proportion of eligible patients initiated on SGLT2i therapy, calculated as number of patients who were prescribed SGLT2i therapy during the intervention period\u002F number of patients meeting predefined eligibility criteria.","24 months",[14,17,20,23,26,29,32,34,36,38],{"measure":15,"description":16,"timeFrame":12},"Adherence to SGLT2i therapy","Patient reported uptake",{"measure":18,"description":19,"timeFrame":12},"Effectiveness","Rates of CKD detection",{"measure":21,"description":22,"timeFrame":12},"Adoption","% of participating centres that initiate implementation strategies.",{"measure":24,"description":25,"timeFrame":12},"Implementation","Acceptability and feasibility of implementation strategies. Fidelity to protocol",{"measure":27,"description":28,"timeFrame":12},"Maintenance","Score for the extent of normalisation of practice (Normalisation Measure Development tool)",{"measure":30,"description":31,"timeFrame":12},"% initiation of other CKD management",null,{"measure":18,"description":33,"timeFrame":12},"Rates of Kidney Failure",{"measure":18,"description":35,"timeFrame":12},"Rates of CV Death",{"measure":18,"description":37,"timeFrame":12},"Rates adverse drug reactions",{"measure":18,"description":39,"timeFrame":12},"Rates all-cause hospitalisations",{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":6,"timePerspective":41,"maskingInfo":31},"PROSPECTIVE","Chronic kidney disease (CKD) affects over 850 million people globally, with 80% living in low- and middle-income countries (LMICs) where access to effective treatment is limited. Sodium-glucose co-transporter 2 inhibitors (SGLT2i), now listed on the WHO Essential Medicines List, have demonstrated significant benefits in slowing CKD progression and reducing cardiovascular mortality. The IMPLEMENT-CKD project is a co-designed, multi-phased, multi-country health systems strengthening initiative aimed at improving equitable access to and sustained use of SGLT2i in Thailand, and the Pacific Islands. The intervention is contextually tailored, prioritising stakeholder engagement, cultural adaptation, and scalable care models. A mixed-method, adaptive implementation study will be conducted in phases. The pre-implementation phase uses community-based participatory action research and knowledge co-creation to develop culturally relevant strategies. During implementation, clinical staff are trained to initiate SGLT2i therapy in eligible adults with CKD (eGFR \\>20 mL\u002Fmin\u002F1.73m²) or type 2 diabetes. Real-world delivery is supported by monthly prescribing audits and mobile surveys. Strategies are refined biannually using Plan-Do-Study-Act (PDSA) cycles. The scale-up phase engages stakeholders to advocate for national inclusion of SGLT2i through policy briefs and collaboration with professional bodies. The primary implementation outcome is 50% reach-defined as the proportion of eligible patients initiated on SGLT2i. Additional outcomes include adoption, fidelity, acceptability, and normalisation of practice. Health systems outcomes include changes in protocols, workforce capacity, medicine availability, and policy engagement. Clinical outcomes such as kidney failure and cardiovascular death will be monitored using routine data. The project aims to enhance CKD management, reduce disparities, and inform scalable, evidence-based policy for chronic disease care in LMICs.","Participants will be recruited from Thailand, Fiji and Samoa.",[45],{"type":6,"name":46,"description":47,"armGroupLabels":31,"otherNames":31},"Implementation of recommendations","The study will be organised into three periods:\n\n* A pre-implementation phase - co-design implementation strategies development in each region;\n* An implementation phase - initiation of SGT2i and evaluation;\n* A post-implementation phase - consolidate learnings and dissemination for scaling up",[49],{"name":50,"affiliation":5,"role":51},"Rathika Krishnasamy","PRINCIPAL_INVESTIGATOR",[53,57],{"name":50,"role":54,"phone":55,"phoneExt":31,"email":56},"CONTACT","+61 401 696 408","implement-ckd@uq.edu.au",{"name":58,"role":54,"phone":31,"phoneExt":31,"email":56},"Laura Hickey",[60,76,92],{"facility":61,"status":31,"city":62,"state":31,"zip":31,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Ministry of Health, Fiji","Suva","Fiji","FJ",{"type":66,"coordinates":67},"Point",[68,69],178.42531,-18.13683,{"lat":69,"lon":68},[72,74],{"name":73,"role":54,"phone":31,"phoneExt":31,"email":56},"Anis Ta'eed",{"name":75,"role":54,"phone":31,"phoneExt":31,"email":31},"Yogeshni Chandra",{"facility":77,"status":31,"city":78,"state":31,"zip":31,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Department of Health, Samoa","Apia","Samoa","WS",{"type":66,"coordinates":82},[83,84],-171.76666,-13.83333,{"lat":84,"lon":83},[87,90],{"name":88,"role":54,"phone":31,"phoneExt":31,"email":89},"Ben Matalavea","lbmatalavea@nkfs.ws",{"name":91,"role":54,"phone":31,"phoneExt":31,"email":31},"Malama Tafuna'i",{"facility":93,"status":31,"city":94,"state":31,"zip":31,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Chulalongkorn University","Bangkok","Thailand","TH",{"type":66,"coordinates":98},[99,100],100.50144,13.75398,{"lat":100,"lon":99},[103],{"name":104,"role":54,"phone":31,"phoneExt":31,"email":31},"Talerngsak Kanjanabuch",{"type":106,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100658782","trial-without-borders-implement-ckd-implementation-of-evidence-based-sglt2i-to-reduce-global-burden-of-cardiovascular-and-chronic-kidney-disease-100658782",false,"NCT07854808","Trial Without Borders IMPLEMENT-CKD: IMPLEMENTation of Evidence-Based SGLT2i to Reduce Global Burden of Cardiovascular and Chronic Kidney Disease","IMPLEMENT-CKD","Inclusion Criteria:\n\nPeople ≥ 18 years of age with one or more of the following:\n\n1. chronic kidney disease (CKD) with eGFR \\> 20 mL\u002Fmin\u002F1.73m²;\n2. type 2 diabetes mellitus (T2DM).\n\nExclusion Criteria:\n\n* Nil","ALL","18 Years",{"count":117,"type":118},1390,"ESTIMATED","OBSERVATIONAL","Chronic kidney disease (CKD) affects millions, especially in low- and middle-income countries, where many die early due to lack of treatment. One group of medicines, called SGLT2 inhibitors (SGLT2i), have been shown to slow down kidney damage and reduce the risk of heart-related deaths. The IMPLEMENT-CKD project will work with communities in Thailand, Fiji and Samoa to make it easier for people with CKD or type 2 diabetes to get these life-saving medicines as part of their regular care.",[122,123,124,125],"Implementation Research","Kidney Disease","Cardiovascular Disease","Chronic Illness",[127,128,129,130],"implementation","kidney disease","chronic illness","cardiovascular disease","NOT_YET_RECRUITING","2026-10-01",{"date":134,"type":135},"2026-10-02","ACTUAL",{"date":137,"type":118},"2027-07-01",{"date":139,"type":118},"2030-08-01",{"name":5,"class":6},3]