Abstract
Objetivos
Evaluar la eficacia de una intervención multidisciplinaria no farmacológica para reducir la mortalidad cardiovascular y los reingresos hospitalarios por insuficiencia cardíaca.
Diseño
Ensayo clínico prospectivo, aleatorizado, abierto, controlado, paralelo y multicéntrico.
Emplazamiento
Centros de atención primaria Sardenya, Les Corts y Vic Sud «El Remei», y hospitales Vall d’Hebron, Clínic, Vic y Dos de Maig.
Participantes
Participarán 300 pacientes con el diagnóstico de insuficiencia cardíaca.
Intervención
Visitas domiciliarias mensuales con llamadas telefónicas intercaladas por personal de enfermería muy bien entrenado donde se proporcionará educación sobre la enfermedad y los tratamientos, optimización del cumplimiento terapéutico, educación sobre el autocontrol y el manejo (particularmente detección precoz y tratamiento de las descompensaciones).
Mediciones principales
Variable combinada de mortalidad por causa cardiovascular y rehospitalizaciones por insuficiencia cardíaca (urgencias y/o ingresos) al cabo de 1 año. Calidad de vida relacionada con la salud.
Discusión
Estudio de carácter abierto, ya que no es posible enmascarar la intervención. La intervención domiciliaria no es excesivamente compleja y puede ser realizada con facilidad por profesionales sanitarios bien entrenados; se podría generalizar su aplicación si se demostrara un grado de eficacia clínicamente relevante.
Palabras clave: Insuficiencia cardíaca, Atención domiciliaria, Intervención multifactorial
Abstract
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, optimize therapy compliance, and inform on selfmonitoring 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.
Key words: Heart failure, Home care, Multi-factorial intervention
Bibliografía
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