Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial

被引:2
作者
Vaillant-Roussel, Helene [1 ,2 ]
Laporte, Catherine [1 ,3 ]
Pereira, Bruno [4 ]
Tanguy, Gilles [1 ]
Cassagnes, Jean [5 ]
Ruivard, Marc [6 ]
Clement, Gilles [1 ]
Le Reste, Jean-Yves [7 ]
Lebeau, Jean-Pierre [8 ]
Chenot, Jean-Francois [9 ]
Pouchain, Denis [8 ]
Dubray, Claude [2 ]
Vorilhon, Philippe [1 ,10 ]
机构
[1] Univ Clermont Ferrand 2, Fac Med, Dept Gen Practice, F-63000 Clermont Ferrand, France
[2] Clermont Ferrand Univ Hosp, INSERM, CIC 501, Clin Invest Ctr, F-63000 Clermont Ferrand, France
[3] Univ Auvergne, Fac Med Clermont Ferrand, EA NPsy Sydo 7280, F-63000 Clermont Ferrand, France
[4] Clermont Ferrand Univ Hosp, Clin Res & Innovat Dept, Biostat Unit, F-63000 Clermont Ferrand, France
[5] Clermont Ferrand Univ Hosp, Dept Cardiol, F-63000 Clermont Ferrand, France
[6] Clermont Ferrand Univ Hosp, Dept Internal Med, F-63000 Clermont Ferrand, France
[7] Brest Univ, Dept Gen Practice, Fac Med, F-29238 Brest, France
[8] Univ Tours, Dept Gen Practice, Fac Med, F-37032 Tours, France
[9] Univ Greifswald, Inst Community Med, Dept Gen Practice, D-17475 Greifswald, Germany
[10] Univ Auvergne, Fac Med Clermont Ferrand, EA 4681PEPRADE, F-63000 Clermont Ferrand, France
关键词
Heart failure; Quality of life; Patient education; Primary care; Cluster-randomised controlled trial; THERAPEUTIC EDUCATION; HEALTH SURVEY; SELF-CHANGE; HIGH-RISK; MANAGEMENT; HOME; REHOSPITALIZATION; QUESTIONNAIRE; PREVALENCE; VALIDATION;
D O I
10.1186/s12875-014-0208-3
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Background: Chronic heart failure, is increasing due to the aging population and improvements in heart disease detection and management. The prevalence is estimated at similar to 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. Discussion: 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.
引用
收藏
页数:9
相关论文
共 41 条
[1]  
Aaronson N K, 1992, Qual Life Res, V1, P349, DOI 10.1007/BF00434949
[2]   Patterns of intra-cluster correlation from primary care research to inform study design and analysis [J].
Adams, G ;
Gulliford, MC ;
Ukoumunne, OC ;
Eldridge, S ;
Chinn, S ;
Campbell, MJ .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2004, 57 (08) :785-794
[3]   Review of randomised trials using the post-randomised consent (Zelen's) design [J].
Adamson, Joy ;
Cockayne, Sarah ;
Puffer, Suezann ;
Torgerson, David J. .
CONTEMPORARY CLINICAL TRIALS, 2006, 27 (04) :305-319
[4]   RESICARD: East Paris network for the management of heart failure: Absence of effect on mortality and rehospitalization in patients with severe heart failure admitted following severe decompensation [J].
Assyag, Patrick ;
Renaud, Thomas ;
Cohen-Solal, Alain ;
Viaud, Magali ;
Krys, Henry ;
Bundalo, Aleksandra ;
Michel, Pierre-Louis ;
Boukobza, Robert ;
Bourgueil, Yann ;
Cohen, Ariel .
ARCHIVES OF CARDIOVASCULAR DISEASES, 2009, 102 (01) :29-41
[5]   Multicenter randomized trial of a comprehensive hospital discharge and outpatient heart failure management program [J].
Atienza, F ;
Anguita, M ;
Martinez-Alzamora, N ;
Osca, J ;
Ojeda, S ;
Almenar, L ;
Ridocci, F ;
Vallés, F ;
de Velasco, JA .
EUROPEAN JOURNAL OF HEART FAILURE, 2004, 6 (05) :643-652
[6]   Identifying relative Cut-Off Scores with Neural Networks for Interpretation of the Minnesota Living with Heart Failure Questionnaire [J].
Behlouli, Hassan ;
Feldman, Deborah E. ;
Ducharme, Anique ;
Frenette, Marc ;
Giannetti, Nadia ;
Grondin, Francois ;
Michel, Caroline ;
Sheppard, Richard ;
Pilote, Louise .
2009 ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY, VOLS 1-20, 2009, :6242-+
[7]   Randomized Clinical Trial of the Effectiveness of a Home-Based Intervention in Patients With Heart Failure: The IC-DOM Study [J].
Brotons, Carlos ;
Falces, Carles ;
Alegre, Jose ;
Ballarin, Elena ;
Casanovas, Jordi ;
Cata, Teresa ;
Martinez, Mireia ;
Moral, Irene ;
Ortiz, Jacint ;
Perez, Eulalia ;
Rayo, Elisabet ;
Recio, Jesus ;
Roig, Eulalia ;
Vidal, Xavier .
REVISTA ESPANOLA DE CARDIOLOGIA, 2009, 62 (04) :400-408
[8]  
Caisse nationale de l'assurance maladie [National heath care insurance], 2012, POINTS DE REPERE, V38, P1
[9]   CONSORT statement: extension to cluster randomised trials [J].
Campbell, MK ;
Elbourne, DR ;
Altman, DG .
BMJ-BRITISH MEDICAL JOURNAL, 2004, 328 (7441) :702-708
[10]   The care for chronic heart failure by general practitioners. Results from a clinical audit in Italy [J].
Cancian, Maurizio ;
Battaggia, Alessandro ;
Celebrano, Mario ;
Del Zotti, Francesco ;
Novelletto, Bruno Franco ;
Michieli, Raff Aella ;
Saugo, Mario ;
Pellizzari, Michele ;
Toffanin, Roberto .
EUROPEAN JOURNAL OF GENERAL PRACTICE, 2013, 19 (01) :3-10