title: Effect of Behavior Modification on Outcome in Early- to Moderate-Stage Chronic Kidney Disease: A Cluster-Randomized Trial.
abstract: OBJECTIVE
  Owing to recent changes in our understanding of the underlying cause of chronic kidney disease (CKD), the importance of lifestyle modification for preventing the progression of kidney dysfunction and complications has become obvious. In addition, effective cooperation between general physicians (GPs) and nephrologists is essential to ensure a better care system for CKD treatment. In this cluster-randomized study, we studied the effect of behavior modification on the outcome of early- to moderate-stage CKD.
  
  
  METHODS
  Stratified open cluster-randomized trial.
  
  
  METHODS
  A total of 489 GPs belonging to 49 local medical associations (clusters) in Japan.
  
  
  METHODS
  A total of 2,379 patients (1,195 in group A (standard intervention) and 1,184 in group B (advanced intervention)) aged between 40 and 74 years, who had CKD and were under consultation with GPs.
  
  
  METHODS
  All patients were managed in accordance with the current CKD guidelines. The group B clusters received three additional interventions: patients received both educational intervention for lifestyle modification and a CKD status letter, attempting to prevent their withdrawal from treatment, and the group B GPs received data sheets to facilitate reducing the gap between target and practice.
  
  
  METHODS
  The primary outcome measures were 1) the non-adherence rate of accepting continuous medical follow-up of the patients, 2) the collaboration rate between GPs and nephrologists, and 3) the progression of CKD.
  
  
  RESULTS
  The rate of discontinuous clinical visits was significantly lower in group B (16.2% in group A vs. 11.5% in group B, p = 0.01). Significantly higher referral and co-treatment rates were observed in group B (p<0.01). The average eGFR deterioration rate tended to be lower in group B (group A: 2.6±5.8 ml/min/1.73 m2/year, group B: 2.4±5.1 ml/min/1.73 m2/year, p = 0.07). A significant difference in eGFR deterioration rate was observed in subjects with Stage 3 CKD (group A: 2.4±5.9 ml/min/1.73 m2/year, group B: 1.9±4.4 ml/min/1.73 m2/year, p = 0.03).
  
  
  CONCLUSIONS
  Our care system achieved behavior modification of CKD patients, namely, significantly lower discontinuous clinical visits, and behavior modification of both GPs and nephrologists, namely significantly higher referral and co-treatment rates, resulting in the retardation of CKD progression, especially in patients with proteinuric Stage 3 CKD.
  
  
  BACKGROUND
  The University Hospital Medical Information Network clinical trials registry UMIN000001159.
authors.affiliation: Department of Nephrology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Yamagata
authors.affiliation: Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Makino
authors.affiliation: Dialysis Unit, University Hospital of the Ryukyus, Okinawa, Japan.
authors.forename: Kunitoshi
authors.initials: K
authors.lastname: Iseki
authors.affiliation: Division of Nephrology, Endocrinology, and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Sadayoshi
authors.initials: S
authors.lastname: Ito
authors.affiliation: Department of Nephrology and Hypertension, St. Marianna University School of Medicine, Kanagawa, Japan.
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Kimura
authors.affiliation: Division of Nephrology, Department of Medicine, Jichi Medical University, Tochigi, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Kusano
authors.affiliation: Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Shibata
authors.affiliation: Department of Nephrology, University of Kumamoto, Kumamoto, Japan.
authors.forename: Kimio
authors.initials: K
authors.lastname: Tomita
authors.affiliation: Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Science, Niigata, Japan.
authors.forename: Ichiei
authors.initials: I
authors.lastname: Narita
authors.affiliation: Division of Nephrology, Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki, Japan.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Nishino
authors.affiliation: Internal Medicine 1, Hamamatsu University School of Medicine, Shizuoka, Japan.
authors.forename: Yoshihide
authors.initials: Y
authors.lastname: Fujigaki
authors.affiliation: Division of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical School, Saitama, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Mitarai
authors.affiliation: Department of Internal Medicine III, Fukushima Medical University School of Medicine, Fukushima, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Watanabe
authors.affiliation: Division of Nephrology, Department of Laboratory Medicine, Institute of Medical, Pharmaceutical, and Health Sciences, Faculty of Medicine, Kanazawa University, Ishikawa, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Wada
authors.affiliation: Japan Dietitian Association, Tokyo, Japan.
authors.forename: Teiji
authors.initials: T
authors.lastname: Nakamura
authors.affiliation: Department of Nephrology, University of Nagoya, Aichi, Japan.
authors.forename: Seiichi
authors.initials: S
authors.lastname: Matsuo
mesh_terms: D001519:Behavior; D016000:Cluster Analysis; D005260:Female; D006801:Humans; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D051436:Renal Insufficiency, Chronic / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome