[Randomised clinical trial to evaluate the efficacy of a multi-factorial intervention to reduce hospitalisation and improve the quality of life of patients with heart failure].
OBJECTIVES: To evaluate the efficacy of a multi-disciplinary non-pharmacological intervention to reduce cardiovascular mortality and hospital re-admissions due to heart failure. DESIGN: Randomised, open, controlled, parallel, multi-centre prospective clinical trial. SETTING: Sardenya Primary Care Centre (PCC), les Corts PCC, "El Remei" PCC (Vic Sud), Vall d'Hebron Hospital, Hospital Clínic, Vic Hospital, Hospital Dos de Maig. PARTICIPANTS: 300 patients diagnosed with heart failure. INTERVENTION: Monthly home visits with intercalated phone calls from very well trained nursing staff to provide education on the illness and treatments, optimise therapy compliance, and inform on self-monitoring and management (especially early detection and treatment of decompensation). MAIN MEASUREMENTS: Combined variable of mortality for cardiovascular reasons and re-hospitalisation due to heart failure (via Casualty and/or Admissions) at 1 year. Health-related quality of life. DISCUSSION: Open study, as it is impossible to mask the intervention. The home intervention is not too complex and is easily performed by well-trained health professionals. Its use could be generalised, if a clinically relevant degree of efficacy was shown.