title: Rationale and design of the Japanese heart failure outpatients disease management and cardiac evaluation (J-HOMECARE).
abstract: BACKGROUND
  Although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (QOL), and medical cost in patients with heart failure (HF), no study has focused on psychological status as an outcome of disease management. In addition, very little information is available on the effectiveness of disease management programs in other areas than the USA and Europe.
  
  
  METHODS
  The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE) is a randomized controlled trial in which 156 patients hospitalized with HF will be randomized into usual care or a home-based disease management arm receiving comprehensive advice and counseling by visiting nurses during the initial 2 months and telephone follow-up for the following 4 months after discharge. This study evaluates depression and anxiety (Hospital Anxiety and Depression Scale), mortality, readmission due to HF, and QOL (Short Form-8). Data are collected during index hospitalization and then 2, 6, and 12 months after discharge. This study started in December 2007, and the final results are expected in 2011.
  
  
  CONCLUSIONS
  The J-HOMECARE will provide important information on the efficacy of disease management for psychological status as well as the effective components of disease management for patients with HF. (ClinicalTrials.gov number, NCT01284400).
authors.affiliation: Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
authors.forename: Miyuki
authors.initials: M
authors.lastname: Tsuchihashi-Makaya
authors.forename: Hisashi
authors.initials: H
authors.lastname: Matsuo
authors.forename: Shigeo
authors.initials: S
authors.lastname: Kakinoki
authors.forename: Shigeru
authors.initials: S
authors.lastname: Takechi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tsutsui
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D001007:Anxiety; D044466:Asian People; D003863:Depression; D019468:Disease Management; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000523:psychology*; D006699:Home Care Services; D006801:Humans; D007564:Japan; D008875:Middle Aged; D011379:Prognosis; D011788:Quality of Life; D018401:Sample Size; D013997:Time Factors; D055815:Young Adult