Fig 1.
We recruited 49 local medical associations (clusters) in 15 different prefectures, which were classified into four regions (strata) based on the level of increase in the rate of dialysis patients [9]. We recruited 557 GPs and 2,417 patients; 2,379 patients from 489 GPs gave consent. After randomization, 68 patients in group B chose to withdraw, while only 13 patients in group A did so. Most of the patients in group B withdrew just after randomization due to an aversion to the educational intervention. Finally, 1,107 patients in group A and 1,029 patients in group B completed this cluster-randomized trial.
Table 1.
Characteristics of the patients at baseline.
Table 2.
Percnetage of Medication of various drugs and their changes during the study.
Fig 2.
Effects of advanced CKD care system on CKD treatment targets.
Items were BMI changes (A), HbA1c changes (B), systolic (C) and diastolic blood pressure changes (D), non-HDL cholesterol changes (E), and hemoglobin changes in subjects with Stage 3 CKD or later (F) during the study period. Patients in group B had greater improvements than those in group A in terms of the CKD practice guide targets, except for hemoglobin level. In particular, BMI, HbA1c, and blood pressure differences between group A and group B gradually increased over the time course of the interventions. Average BMI was significantly reduced in group B patients 2 years after starting the advanced intervention, and HbA1c was also significantly reduced in group B patients 2.5 years after starting the advanced intervention. * indicates p<0.05 between group A and group B by Student’s T test.
Table 3.
Primary outcomes.
Table 4.
Proportion of adherence to the complete CKD treatment guide.
Fig 3.
CKD treatment control achievements during the study period.
CKD treatment cumulative achievements for BMI <25 (A), HbA1c <6.9% (B), controlled blood pressure (C), smoking cessation (D), non-HDL-C <150 mg/dl (E), and proportion of hemoglobin concentration controlled to 10–12 g/dl among CKD stages 3, 4, and 5 (F). There was no significant difference between group A and group B in CKD treatment control achievements by generalized linear mixed model. Patients in group B had greater cumulative incidences of achieving the targets of BMI <25, glycated hemoglobin <6.9%, and other measured risk factors, except for non-HDL cholesterol level and smoking cessation rate. In particular, cumulative differences in the rates of achieving BMI, HbA1c, and blood pressure targets between group A and group B gradually widened over the course of the interventions.
Fig 4.
Both the number of subjects with a doubling of serum creatinine and the number with a 50% reduction in eGFR significantly decreased in group B. The cumulative incidence of a doubling of serum creatinine or a 50% reduction in eGFR also exhibited a gradually increasing difference between groups A and B over the course of the study. A significant difference was shown between Group A and Group B by generalized linear mixed model.