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Original Articles

Long-Term Prospective, Randomized, Controlled Study Using Repetitive Education at Six-Month Intervals and Monitoring for Adherence in Heart Failure Outpatients

The REMADHE Trial

Edimar Alcides Bocchi, MD; Fátima Cruz, RN; Guilherme Guimarães, PhE; Luiz Felipe Pinho Moreira, MD; Victor Sarli Issa, MD; Silvia Moreira Ayub Ferreira, MD; Paulo Roberto Chizzola, MD; Germano Emilio Conceição Souza, MD; Sara Brandão, RN and Fernando Bacal, MD

From the Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da University of São Paulo, São Paulo, Brazil.

Correspondence to Dr Edimar Alcides Bocchi, Rua Oscar Freire 2077, apto 161, São Paulo, Brazil, CEP 05409-011. E-mail dcledimar{at}incor.usp.br

Received October 8, 2007; accepted May 13, 2008.

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

Methods and 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.

Key Words: heart failure • education • disease program management • case management • controlled clinical trials • quality of life • patient compliance

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CLINICAL PERSPECTIVE

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