title: Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial.
abstract: BACKGROUND
  Chronic heart failure, is increasing due to the aging population and improvements in heart disease detection and management. The prevalence is estimated at ~10% of the French general practice patient population over 59 years old. The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner (GP) education in primary care.
  
  
  METHODS
  A randomised, cluster controlled trial, stratified over 4 areas of the Auvergne region in France comparing intervention and control groups. The inclusion criteria are: patients older than 50 years with New York Heart Association (NYHA) stage I, II, or III heart failure, with reduced ejection fraction or with preserved ejection fraction. Heart failure should be confirmed by the patient's cardiologist according to the European Society of Cardiology guidelines criteria. The exclusion criteria include: severe cognitive disorders, living in an institution, participating in another clinical trial, having NYHA stage IV heart failure, or a lack of French language skills. The complex intervention consists of training at the GP practice with an interactive 2-day workshop to provide a patient's education programme. GPs are trained to perform case management, lifestyle counselling and motivational interviewing, to educate patients on the main topics including clinical alarm signs, physical activity, diet and cardiovascular risk factors. The patients' education sessions are scheduled at 1, 4, 7, 10, 13 and 19 months following the start of the trial. The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires: the Minnesota Living with Heart Failure Questionnaire and SF-36. To detect a difference in the mean quality of life at 19 months, we anticipate studying a minimum of 400 patients from 80 GPs.
  
  
  CONCLUSIONS
  This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a 2-day GP workshop and patients' education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure. This complex intervention tool could be used during initial and further medical training.
  
  
  BACKGROUND
  ETIC is a cluster-randomised, controlled trial registered on ClinicalTrials.gov [ NCT01065142 , 2010, Feb 8] and the French drug agency [Agence Nationale de Sécurité du Médicament et des produits de santé; registration number: 2009-A01142-55, on March 5th, 2010].
authors.affiliation: General Practice Department, Faculty of Medicine of Clermont-Ferrand University, 28 Place Henri Dunant, 63000, Clermont-Ferrand, France. helene.vaillant_roussel@udamail.fr.|Clinical Investigation Center, INSERM CIC 501, Clermont-Ferrand University Hospital, 58 Rue Montalembert, 63000, Clermont-Ferrand, France. helene.vaillant_roussel@udamail.fr.
authors.forename: Hélène
authors.initials: H
authors.lastname: Vaillant-Roussel
authors.affiliation: General Practice Department, Faculty of Medicine of Clermont-Ferrand University, 28 Place Henri Dunant, 63000, Clermont-Ferrand, France. catherine.laporte@udamail.fr.|EA 7280 NPsy-Sydo, University of Auvergne, Faculty of Medicine of Clermont-Ferrand, 28 Place Henri Dunant, 63000, Clermont-Ferrand, France. catherine.laporte@udamail.fr.
authors.forename: Catherine
authors.initials: C
authors.lastname: Laporte
authors.affiliation: Biostatistics unit, Clinical Research and Innovation Department, Clermont-Ferrand University Hospital, 58 Rue Montalembert, 63000, Clermont-Ferrand, France. bpereira@chu-clermontferrand.fr.
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.affiliation: General Practice Department, Faculty of Medicine of Clermont-Ferrand University, 28 Place Henri Dunant, 63000, Clermont-Ferrand, France. gilles.tanguy@udamail.fr.
authors.forename: Gilles
authors.initials: G
authors.lastname: Tanguy
authors.affiliation: Cardiology Department, Clermont-Ferrand University Hospital, 58 Rue Montalembert, 63000, Clermont-Ferrand, France. jcassagnes@chu-clermontferrand.fr.
authors.forename: Jean
authors.initials: J
authors.lastname: Cassagnes
authors.affiliation: Internal Medicine Department, Clermont-Ferrand University Hospital, Place Lucie et Raymond Aubrac, 63000, Clermont-Ferrand, France. mruivard@chu-clermontferrand.fr.
authors.forename: Marc
authors.initials: M
authors.lastname: Ruivard
authors.affiliation: General Practice Department, Faculty of Medicine of Clermont-Ferrand University, 28 Place Henri Dunant, 63000, Clermont-Ferrand, France. gilles.clement@udamail.fr.
authors.forename: Gilles
authors.initials: G
authors.lastname: Clément
authors.affiliation: General Practice Department, Faculty of Medicine of Brest University, 22 avenue Camille Desmoulins, 29238, Brest, France. lereste@univ-brest.fr.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Le Reste
authors.affiliation: General Practice Department, Faculty of Medicine of Tours University, 10 boulevard Tonnellé, 37032, Tours, France. jp.lebeau@exercer.fr.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lebeau
authors.affiliation: General Practice Department, Institute of Community Medicine, University of Greifswald, Fleischmannstr. 42-44, 17475, Greifswald, Germany. jchenot@uni-greifswald.de.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Chenot
authors.affiliation: General Practice Department, Faculty of Medicine of Tours University, 10 boulevard Tonnellé, 37032, Tours, France. denis.pouchain@free.fr.
authors.forename: Denis
authors.initials: D
authors.lastname: Pouchain
authors.affiliation: Clinical Investigation Center, INSERM CIC 501, Clermont-Ferrand University Hospital, 58 Rue Montalembert, 63000, Clermont-Ferrand, France. claude.dubray@udamail.fr.
authors.forename: Claude
authors.initials: C
authors.lastname: Dubray
authors.affiliation: General Practice Department, Faculty of Medicine of Clermont-Ferrand University, 28 Place Henri Dunant, 63000, Clermont-Ferrand, France. philippe.vorilhon@udamail.fr.|EA 4681PEPRADE, University of Auvergne, Faculty of Medicine of Clermont-Ferrand, 28 Place Henri Dunant, 63000, Clermont-Ferrand, France. philippe.vorilhon@udamail.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Vorilhon
mesh_terms: D000368:Aged; D002908:Chronic Disease; D019468:Disease Management; D005260:Female; D005602:France; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods*; D011320:Primary Health Care / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome