title: Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics).
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  (ClinicalTrials.gov number, NCT01076465).
authors.affiliation: 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. carlos.rodriguez.pascual@sergas.es
authors.forename: Carlos Rodríguez
authors.initials: CR
authors.lastname: Pascual
authors.forename: Emilio Paredes
authors.initials: EP
authors.lastname: Galán
authors.forename: Jose Luis Gonzalez
authors.initials: JL
authors.lastname: Guerrero
authors.forename: Rocio Menendez
authors.initials: RM
authors.lastname: Colino
authors.forename: Pedro Abizanda
authors.initials: PA
authors.lastname: Soler
authors.forename: Mercedes Hornillos
authors.initials: MH
authors.lastname: Calvo
authors.forename: Juan Jose Solano
authors.initials: JJ
authors.lastname: Jaurieta
authors.forename: Jorge Manzarbeitia
authors.initials: JM
authors.lastname: Arambarri
authors.forename: Jose Manuel Ribera
authors.initials: JM
authors.lastname: Casado
authors.forename: Fernando
authors.initials: F
authors.lastname: Rodríguez-Artalejo
mesh_terms: D000368:Aged; D015897:Comorbidity; D019468:Disease Management; D005500:Follow-Up Studies; D006333:Heart Failure / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D015397:Program Evaluation; D012107:Research Design; D013030:Spain / Q000453:epidemiology; D016896:Treatment Outcome