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

<p>Abstract</p> <p>Background</p> <p>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 Mult...

Full description

Bibliographic Details
Main Authors: Casado Jose, Arambarri Jorge, Jaurieta Juan, Calvo Mercedes, Soler Pedro, Colino Rocio, Guerrero Jose, Galán Emilio, Pascual Carlos, Rodríguez-Artalejo Fernando
Format: Article
Language:English
Published: BMC 2011-08-01
Series:BMC Public Health
Online Access:http://www.biomedcentral.com/1471-2458/11/627
_version_ 1818358876683108352
author Casado Jose
Arambarri Jorge
Jaurieta Juan
Calvo Mercedes
Soler Pedro
Colino Rocio
Guerrero Jose
Galán Emilio
Pascual Carlos
Rodríguez-Artalejo Fernando
author_facet Casado Jose
Arambarri Jorge
Jaurieta Juan
Calvo Mercedes
Soler Pedro
Colino Rocio
Guerrero Jose
Galán Emilio
Pascual Carlos
Rodríguez-Artalejo Fernando
author_sort Casado Jose
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>(ClinicalTrials.gov number, <a href="http://www.clinicaltrials.gov/ct2/show/NCT01076465">NCT01076465</a>).</p>
first_indexed 2024-12-13T20:35:58Z
format Article
id doaj.art-44320f8361a64c699b6c8891fb315955
institution Directory Open Access Journal
issn 1471-2458
language English
last_indexed 2024-12-13T20:35:58Z
publishDate 2011-08-01
publisher BMC
record_format Article
series BMC Public Health
spelling doaj.art-44320f8361a64c699b6c8891fb3159552022-12-21T23:32:17ZengBMCBMC Public Health1471-24582011-08-0111162710.1186/1471-2458-11-627Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics)Casado JoseArambarri JorgeJaurieta JuanCalvo MercedesSoler PedroColino RocioGuerrero JoseGalán EmilioPascual CarlosRodríguez-Artalejo Fernando<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>(ClinicalTrials.gov number, <a href="http://www.clinicaltrials.gov/ct2/show/NCT01076465">NCT01076465</a>).</p>http://www.biomedcentral.com/1471-2458/11/627
spellingShingle Casado Jose
Arambarri Jorge
Jaurieta Juan
Calvo Mercedes
Soler Pedro
Colino Rocio
Guerrero Jose
Galán Emilio
Pascual Carlos
Rodríguez-Artalejo Fernando
Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics)
BMC Public Health
title Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics)
title_full Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics)
title_fullStr Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics)
title_full_unstemmed Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics)
title_short Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics)
title_sort rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients hf geriatrics
url http://www.biomedcentral.com/1471-2458/11/627
work_keys_str_mv AT casadojose rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics
AT arambarrijorge rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics
AT jaurietajuan rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics
AT calvomercedes rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics
AT solerpedro rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics
AT colinorocio rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics
AT guerrerojose rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics
AT galanemilio rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics
AT pascualcarlos rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics
AT rodriguezartalejofernando rationaleandmethodsofthemulticenterrandomisedtrialofaheartfailuremanagementprogrammeamonggeriatricpatientshfgeriatrics