title: Long-term prospective, randomized, controlled study using repetitive education at six-month intervals and monitoring for adherence in heart failure outpatients: the REMADHE trial.
abstract: BACKGROUND
  The effectiveness of heart failure disease management programs in patients under cardiologists' care over long-term follow-up is not established.
  
  
  RESULTS
  We investigated the effects of a disease management program with repetitive education and telephone monitoring on primary (combined death or unplanned first hospitalization and quality-of-life changes) and secondary end points (hospitalization, death, and adherence). The REMADHE [Repetitive Education and Monitoring for ADherence for Heart Failure] trial is a long-term randomized, prospective, parallel trial designed to compare intervention with control. One hundred seventeen patients were randomized to usual care, and 233 to additional intervention. The mean follow-up was 2.47+/-1.75 years, with 54% adherence to the program. In the intervention group, the primary end point composite of death or unplanned hospitalization was reduced (hazard ratio, 0.64; confidence interval, 0.43 to 0.88; P=0.008), driven by reduction in hospitalization. The quality-of-life questionnaire score improved only in the intervention group (P<0.003). Mortality was similar in both groups. Number of hospitalizations (1.3+/-1.7 versus 0.8+/-1.3, P<0.0001), total hospital days during the follow-up (19.9+/-51 versus 11.1+/-24 days, P<0.0001), and the need for emergency visits (4.5+/-10.6 versus 1.6+/-2.4, P<0.0001) were lower in the intervention group. Beneficial effects were homogeneous for sex, race, diabetes and no diabetes, age, functional class, and etiology.
  
  
  CONCLUSIONS
  For a longer follow-up period than in previous studies, this heart failure disease management program model of patients under the supervision of a cardiologist is associated with a reduction in unplanned hospitalization, a reduction of total hospital days, and a reduced need for emergency care, as well as improved quality of life, despite modest program adherence over time.
authors.affiliation: Heart Institute do Hospital das Clínicas da Faculdade de Medicina da University of São Paulo, São Paulo, Brazil.
authors.forename: Edimar Alcides
authors.initials: EA
authors.lastname: Bocchi
authors.forename: Fátima
authors.initials: F
authors.lastname: Cruz
authors.forename: Guilherme
authors.initials: G
authors.lastname: Guimarães
authors.forename: Luiz Felipe
authors.initials: LF
authors.lastname: Pinho Moreira
authors.forename: Victor Sarli
authors.initials: VS
authors.lastname: Issa
authors.forename: Silvia Moreira
authors.initials: SM
authors.lastname: Ayub Ferreira
authors.forename: Paulo Roberto
authors.initials: PR
authors.lastname: Chizzola
authors.forename: Germano Emilio Conceição
authors.initials: GE
authors.lastname: Souza
authors.forename: Sara
authors.initials: S
authors.lastname: Brandão
authors.forename: Fernando
authors.initials: F
authors.lastname: Bacal
mesh_terms: D001938:Brazil / Q000453:epidemiology; D019090:Case Management / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006760:Hospitalization / Q000639:trends; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D010349:Patient Compliance / Q000706:statistics & numerical data*; D010353:Patient Education as Topic / Q000379:methods*; D011446:Prospective Studies; D011785:Quality Assurance, Health Care / Q000379:methods; D011788:Quality of Life; D011795:Surveys and Questionnaires; D015996:Survival Rate / Q000639:trends; D013997:Time Factors