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Randomized Controlled Trial
. 2005 Sep 30;36(5):280-3.
doi: 10.1157/13079151.

[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]

[Article in Spanish]
C Brotons  1 , M Martínez, E Rayó, C Morralla, E Ballarín, E Pérez; Investigadores del Estudio IC-DOM
Affiliations
Randomized Controlled Trial

[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]

[Article in Spanish]
C Brotons et al. Aten Primaria. .

Abstract
in English, Spanish

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.

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.

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