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Open Access Study protocol

Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics)

Carlos Rodríguez Pascual1*, Emilio Paredes Galán3, Jose Luis Gonzalez Guerrero4, Rocio Menendez Colino5, Pedro Abizanda Soler6, Mercedes Hornillos Calvo7, Juan Jose Solano Jaurieta8, Jorge Manzarbeitia Arambarri9, Jose Manuel Ribera Casado10 and Fernando Rodríguez-Artalejo2

Author Affiliations

1 Servicio de Geriatría. Hospital Meixoeiro. Complejo Hospitalario Universitario de Vigo. Departamento de Medicina. Universidad de Santiago de Compostela. Meixoeiro s.n. 36200 Vigo (Pontevedra). SPAIN

2 Departamento de Medicina Preventiva y Salud Pública. Universidad Autónoma de Madrid/IdiPaz. CIBER of Epidemiology and Public Health. C/Arzobispo Morzillo s.n. 28029 Madrid. SPAIN

3 Servicio de Cardiología. Hospital Meixoeiro. Complejo Hospitalario Universitario de Vigo. Meixoeiro s.n. 36200 Vigo (Pontevedra). SPAIN

4 Servicio de Geriatría. Hospital Nuestra Señora de la Montaña. Complejo Hospitalario de Caceres. Av. España no 2. 10004 Caceres. SPAIN

5 Servicio de Geriatría. Hospital Universitario La Paz. Departamento de Medicina. Facultad de Medicina. Universidad Autónoma de Madrid. Po de la Castellana, 261. 28046 Madrid. SPAIN

6 Servicio de Geriatría. Complejo Hospitalario de Albacete. Departamento de Medicina. Universidad de Castilla-La Mancha. C/Seminario 4. 02006 Albacete. SPAIN

7 Servicio de Geriatría. Hospital Universitario de Guadalajara. Departamento de Medicina, Universidad de Alcalá. C/Donantes de Sangre s.n.19002 Guadalajara. SPAIN

8 Servicio de Geriatría. Hospital Monte Naranco. Complejo Hospitalario de Oviedo. Departamento de Medicina, Universidad de Oviedo. Avda. Dres. Fernandez Vega s/n33012 Oviedo. SPAIN

9 Servicio de Geriatría. Hospital Universitario de Getafe. Departamento de Medicina. Universidad Europea de Madrid. Ctra. de Toledo, Km. 12,5. 28905 Getafe (Madrid). Spain

10 Servicio de Geriatría. Hospital Universitario San Carlos. Departamento de Medicina. Facultad de Medicina. Universidad Complutense de Madrid. C/Profesor Martín Lagos s.n. 28040 Madrid. SPAIN

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BMC Public Health 2011, 11:627  doi:10.1186/1471-2458-11-627

Published: 5 August 2011

Abstract

Background

Disease management programmes (DMPs) have been shown to reduce hospital readmissions and mortality in adults with heart failure (HF), but their effectiveness in elderly patients or in those with major comorbidity is unknown. The Multicenter Randomised Trial of a Heart Failure Management Programme among Geriatric Patients (HF-Geriatrics) assesses the effectiveness of a DMP in elderly patients with HF and major comorbidity.

Methods/Design

Clinical trial in 700 patients aged ≥ 75 years admitted with a primary diagnosis of HF in the acute care unit of eight geriatric services in Spain. Each patient should meet at least one of the following comorbidty criteria: Charlson index ≥ 3, dependence in ≥ 2 activities of daily living, treatment with ≥ 5 drugs, active treatment for ≥ 3 diseases, recent emergency hospitalization, severe visual or hearing loss, cognitive impairment, Parkinson's disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), anaemia, or constitutional syndrome. Half of the patients will be randomly assigned to a 1-year DMP led by a case manager and the other half to usual care. The DMP consists of an educational programme for patients and caregivers on the management of HF, COPD (knowledge of the disease, smoking cessation, immunizations, use of inhaled medication, recognition of exacerbations), diabetes (knowledge of the disease, symptoms of hyperglycaemia and hypoglycaemia, self-adjustment of insulin, foot care) and depression (knowledge of the disease, diagnosis and treatment). It also includes close monitoring of the symptoms of decompensation and optimisation of treatment compliance. The main outcome variables are quality of life, hospital readmissions, and overall mortality during a 12-month follow-up.

Discussion

The physiological changes, lower life expectancy, comorbidity and low health literacy associated with aging may influence the effectiveness of DMPs in HF. The HF-Geriatrics study will provide direct evidence on the effect of a DMP in elderly patients with HF and high comorbidty, and will reduce the need to extrapolate the results of clinical trials in adults to elderly patients.

Trial registration

(ClinicalTrials.gov number, NCT01076465).