[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579544":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":30,"responsibleParty":44,"collaborators":48,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":12,"enrollmentInfo":65,"targetDuration":12,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":12,"overallStatus":75,"whyStopped":12,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Guangdong Provincial People's Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care Group","NO_INTERVENTION","Participants in the control group will receive the usual care protocol. Healthcare personnel at the control center only receive routine community training without additional medical education interventions. These healthcare personnel provide routine diagnosis and treatment to patients as well as subsequent follow-up.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"CKD Patient Management Based on Guidelines","ACTIVE_COMPARATOR","The intervention group will implement comprehensive management for CKD patients based on guidelines, including lifestyle education, pharmacological treatment, risk factor management, risk assessment, referral management, and the completion of the CKD patient management checklist.",[18],"Behavioral: CKD Patient Management Based on Guidelines",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"BEHAVIORAL","1. Lifestyle Education: smoking cessation, physical activity, healthy eating, and weight management.\n2. Pharmacological Treatment: Implement targeted and guideline-based pharmacological treatment plans for patients with different comorbidities, such as the use of RAAS inhibitors (RASi), SGLT2 inhibitors, statins, and other medications.\n3. Risk Factor Management: Effectively manage risk factors such as hypertension, diabetes, and dyslipidemia, and regularly reassess these factors.\n4. Risk Assessment: Perform risk assessments for CKD patients based on eGFR and UACR, and implement graded management according to the results.\n\n4、Referral Management: Refer patients with eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m² or severe proteinuria.\n\n5、CKD Patient Management Checklist: Community doctors should complete the CKD patient management checklist in a standardized manner, including records of risk factors, dynamic kidney function, and follow-up plans.",[14],[25],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"JiYan Chen, PHD","CONTACT","86-020-83827812-10528","Chen-jiyan@163.com",[31],{"facility":5,"status":12,"city":32,"state":33,"zip":12,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Guangzhou","Guangdong","China","CN",{"type":37,"coordinates":38},"Point",[39,40],113.25,23.11667,{"lat":40,"lon":39},[43],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Jiyan Chen","professor",[49,51,53],{"name":50,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital",{"name":52,"class":6},"First Affiliated Hospital of Chongqing Medical University",{"name":54,"class":6},"The First Affiliated Hospital of Dalian Medical University","100579544","guideline-directed-management-for-chronic-kidney-disease-evaluation-of-an-education-progamme-in-a-national-cluster-randomized-controlled-trial-100579544",false,"NCT06825676","Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial","Guideline-diRected MAnagement for Chronic Kidney Disease: EValuation of an Education Progamme in a National Cluster Randomized Controlled Trial (GRAVER)","GRAVER","Inclusion Criteria:\n\nPatients with chronic kidney disease (CKD) (defined as eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m² or UACR \\>30 mg\u002Fg on two occasions at least 3 months apart).\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. Patients with end-stage renal disease (eGFR \\\u003C15 ml\u002Fmin\u002F1.73 m²) or those already receiving regular dialysis or kidney transplantation\n3. Pregnant or breastfeeding women\n4. Patients currently participating in any other clinical trial\n5. Patients who exhibit characteristics during the screening phase that indicate an inability to complete the study","ALL","18 Years",{"count":66,"type":67},1800,"ESTIMATED","INTERVENTIONAL",[70],"NA","Study Objective:\n\nTo evaluate the impact of guideline-based CKD comprehensive management medical re-education for community healthcare providers on improving cardio-renal outcomes in CKD patients.\n\nStudy Design:\n\nA nationwide, multicenter, prospective, cluster-randomized controlled trial.\n\nInclusion and Exclusion Criteria:\n\nInclusion Criteria: Chronic kidney disease (CKD) patients meeting the following criteria:\n\neGFR \\\u003C60 mL\u002Fmin\u002F1.73 m² or UACR \\>30 mg\u002Fg on two separate occasions at least 3 months apart.\n\nExclusion Criteria:\n\nAge \\\u003C18 years. End-stage renal disease (ESRD) with eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m², or patients already on regular dialysis or having received a kidney transplant.\n\nPregnant or breastfeeding women. Patients participating in any other clinical trials. Patients who exhibit characteristics at the screening stage that suggest they are unable to complete the study.\n\nIntervention:\n\nControl Group: Routine community training and management. Intervention Group: Training for community healthcare providers on guideline-based CKD management, including lifestyle management, risk assessment and referral recommendations, risk factor control, pharmacological treatment, and the application of a CKD management checklist incorporating these components.\n\nEfficacy Evaluation Indicators:\n\nPrimary Outcome:\n\nA renal composite endpoint, defined as at least a 25% decline in eGFR, progression to ESRD (dialysis, kidney transplantation, or sustained eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m²), or death due to renal or cardiovascular causes.\n\nSecondary Outcomes:\n\nCardiovascular composite endpoint: cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and hospitalization for heart failure.\n\nDelayed CKD progression, defined as a reduction in the annual eGFR decline rate by 0.5-1 mL\u002Fmin\u002F1.73 m² or a 30% reduction in UACR per year.\n\nProportion of patients receiving guideline-recommended pharmacological treatment.\n\nSafety Evaluation Indicators:\n\nAcute deterioration of renal function (serum creatinine increase \\>30% within 4 weeks).\n\nNew-onset hyperkalemia. Symptomatic hypotension. Recurrent hypoglycemia.",[73,74],"Renal Insufficiency, Chronic","Cardiovascular Diseases (CVD)","NOT_YET_RECRUITING","2025-02-09",{"date":78,"type":79},"2025-02-13","ACTUAL",{"date":81,"type":67},"2025-03",{"date":83,"type":67},"2027-03",{"name":5,"class":6},1]