Published Online
on May 28, 2008

A more recent version of this article appeared on July 1, 2008

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Original Article

A Long-term Prospective Randomized Controlled Study Using Repetitive Education at Six-Month Intervals and Monitoring for Adherence in Heart Failure Outpatients: The REMADHE Study

Edimar A Bocchi¹; Fátima Cruz; Guilherme Guimarães; Luiz Felipe Pinho Moreira; Victor Sarli Issa; Silvia Moreira Ayub Ferreira; Paulo Roberto Chizzola; Germano Emilio Conceição Souza; Sara Brandão and Fernando Bacal

Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da USP

¹ E-mail: dcledimar{at}incor.usp.br

Background—The effectiveness of heart failure(HF) disease management programs(DMP) in patients under cardiologists' care over long-term follow-up is not established.

Methods—We investigated the effects of a DMP 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). REMADHE is a long-term randomized, prospective, parallel trial designed to compare intervention versus control. 117 patients were randomized to usual care, and 233 to additional intervention. Results The mean follow-up was 2.47±1.75 years with 54% adherence to the program. In the intervention group, the primary endpoint composite of death or unplanned hospitalization was reduced (hazard ratio 0.64, CI 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.000). Mortality was similar in both groups. Number of hospitalizations (1.3±1.7 versus 0.8±1.3, p<0.0001), total hospital days over 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—Over longer follow-up than previous studies, this HFDMP model in patients already cared for by a cardiologist is associated with reduction in unplanned hospitalization, total hospital days and need for emergency care, as well as improved quality of life, despite modest program adherence over time.

Key Words: case management • controlled clinical trials • disease program management • education • heart failure