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

BMC Family Practice

Volumn 15, Issue 1, 2014, Pages

  Vaillant Roussel, Hélène ^a,b   Laporte, Catherine ^a,c   Pereira, Bruno ^b   Tanguy, Gilles ^a   Cassagnes, Jean ^b   Ruivard, Marc ^b   Clément, Gilles ^a   Le Reste, Jean Yves ^d   Lebeau, Jean Pierre ^e   Chenot, Jean Franҫois ^f   Pouchain, Denis ^e   Dubray, Claude ^b   Vorilhon, Philippe ^a  

^a UNIVERSITÉ CLERMONT AUVERGNE   (France)

^b UNIVERSITY HOSPITAL OF CLERMONT FERRAND   (France)

^c UNIVERSITÉ CLERMONT AUVERGNE   (France)

^d FACULTÉ DE MÉDECINE ET DES SCIENCES DE LA SANTÉ   (France)

^e UNIVERSITÉ DE TOURS   (France)

^f UNIVERSITY OF GREIFSWALD   (Germany)

Author keywords

Cluster randomised controlled trial; Heart failure; Patient education; Primary care; Quality of life

Indexed keywords

AGED; CHRONIC DISEASE; CONTROLLED STUDY; DISEASE MANAGEMENT; FEMALE; FRANCE; HEART FAILURE; HUMAN; MALE; MIDDLE AGED; PATIENT EDUCATION; PRIMARY HEALTH CARE; PROCEDURES; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

AGED; CHRONIC DISEASE; DISEASE MANAGEMENT; FEMALE; FRANCE; HEART FAILURE; HUMANS; MALE; MIDDLE AGED; PATIENT EDUCATION AS TOPIC; PRIMARY HEALTH CARE; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 84923876794     PISSN: None     EISSN: 14712296     Source Type: Journal    
DOI: 10.1186/s12875-014-0208-3     Document Type: Article

References (41)

1. Cowie MR, Wood DA, Coats AJ, Thompson SG, Poole-Wilson PA, Suresh V, Sutton GC: Incidence and aetiology of heart failure; a population-based study. Eur Heart J 1999, 20:421-428.
2. Saudubray T, Saudubray C, Viboud C, Jondeau G, Valleron A-J, Flahault A, Hanslik T: Prevalence and management of heart failure in France: national study among general practitioners of the Sentinelles network. Rev Med Interne 2005, 26:845-850.
3. Ceia F, Fonseca C, Mota T, Morais H, Matias F, de Sousa A, Oliveira AG, on behalf of the EPICA Investigators: Prevalence of chronic heart failure in Southwestern Europe: the EPICA study. Eur J Heart Fail 2002, 4:531-539.
4. Delahaye F, Roth O, Aupetit JF, de Gevigney G: Epidemiology and prognosis of cardiac insufficiency. Arch Mal Coeur Vaiss 2001, 94:1393-1403.
5. Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJV, Ponikowski P, Poole- Wilson PA, Strömberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL: ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the task force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J 2008, 29:2388-2442.
6. Roccaforte R, Demers C, Baldassarre F, Teo KK, Yusuf S: Effectiveness of comprehensive disease management programmes in improving clinical outcomes in heart failure patients. A meta-analysis. Eur J Heart Fail 2005, 7:1133-1144.
7. Assyag P, Renaud T, Cohen-Solal A, Viaud M, Krys H, Bundalo A, Michel PL, Boukobza R, Bourgueil Y, Cohen A: 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. Arch Cardiovasc Dis 2009, 102:29-41.
8. Juillière Y, Jourdain P, Roncalli J, Trochu JN, Gravoueille E, Guibert H, Lambert H, Neau S, Spinazze L, Tallec N, Bachèlerie C, Beauvais F, Ertzinger C, Jondeau G: Therapeutic education for cardiac failure patients: the I-care programme. Arch Mal Coeur Vaiss 2005, 98:300-307.
9. Dendale P, De Keulenaer G, Troisfontaines P, Weytjens C, Mullens W, Elegeert I, Ector B, Houbrechts M, Willekens K, Hansen D: Effect of a telemonitoring-facilitated collaboration between general practitioner and heart failure clinic on mortality and rehospitalization rates in severe heart failure: the TEMA-HF 1 (TElemonitoring in the MAnagement of Heart Failure) study. Eur J Heart Fail 2012, 14:333-340.
10. Kasper EK, Gerstenblith G, Hefter G, Van Anden E, Brinker JA, Thiemann DR, Terrin M, Forman S, Gottlieb SH: A randomized trial of the efficacy of multidisciplinary care in heart failure outpatients at high risk of hospital readmission. J Am Coll Cardiol 2002, 39:471-480.
11. Stewart S, Carrington MJ, Marwick TH, Davidson PM, Macdonald P, Horowitz JD, Krum H, Newton PJ, Reid C, Chan YK, Scuffham PA: Impact of home versus clinic-based management of chronic heart failure: the which? (which heart failure intervention is most cost-effective & consumer friendly in reducing Hospital Care) Multicenter, randomized trial. J Am Coll Cardiol 2012, 60:1239-1248.
12. Atienza F, Anguita M, Martinez-Alzamora N, Osca J, Ojeda S, Almenar L, Ridocci F, Vallés F, de Velasco JA: Multicenter randomized trial of a comprehensive hospital discharge and outpatient heart failure management program. Eur J Heart Fail 2004, 6:643-652.
13. Harrison MB, Browne GB, Roberts J, Tugwell P, Gafni A, Graham ID: Quality of life of individuals with heart failure: a randomized trial of the effectiveness of two models of hospital-to-home transition. Med Care 2002, 40:271-282.
14. De la Porte PWFB-A, Lok DJA, van Veldhuisen DJ, van Wijngaarden J, Cornel JH, Zuithoff NPA, Zuithoff NP, Badings E, Hoes AW: Added value of a physician-and-nurse-directed heart failure clinic: results from the Deventer-Alkmaar heart failure study. Heart 2007, 93:819-825.
15. Peters-Klimm F, Campbell S, Hermann K, Kunz CU, Müller-Tasch T, Szecsenyi J, the Competence Network Heart Failure: Case management for patients with chronic systolic heart failure in primary care: the HICMan exploratory randomised controlled trial. Trials 2010, 11:56.
16. Leplège A, Ecosse E, Verdier A, Perneger TV: The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol 1998, 51:1013-1023.
17. Aaronson NK, Acquadro C, Alonso J, Apolone G, Bucquet D, Bullinger M, Bungay K, Fukuhara S, Gandek B, Keller S: International Quality of Life Assessment (IQOLA) Project. Qual Life Res 1992, 1:349-351.
18. Behlouli H, Feldman DE, Ducharme A, Frenette M, Giannetti N, Grondin F, Michel C, Sheppard R, Pilote L: Identifying relative cut-off scores with neural networks for interpretation of the Minnesota Living with Heart Failure questionnaire. Conf Proc IEEE Eng Med Biol Soc 2009, 2009:6242-6246.
19. Girerd X, Hanon O, Anagnostopoulos K, Ciupek C, Mourad JJ, Consoli S: Assessment of antihypertensive compliance using a self-administered questionnaire: development and use in a hypertension clinic. Presse Med 2001, 30:1044-1048.
20. Whitlock EP, Orleans CT, Pender N, Allan J: Evaluating primary care behavioral counseling interventions: an evidence-based approach. Am J Prev Med 2002, 22:267-284.
21. DiClemente CC, Prochaska JO: Self-change and therapy change of smoking behavior: a comparison of processes of change in cessation and maintenance. Addict Behav 1982, 7:133-142.
22. Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ: Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol 2004, 57:785-794.
23. Brotons C, Falces C, Alegre J, Ballarín E, Casanovas J, Catà T, Martínez M, Moral I, Ortiz J, Pérez E, Rayó E, Recio J, Roig E, Vidal X: Randomized clinical trial of the effectiveness of a home-based intervention in patients with heart failure: the IC-DOM study. Rev Esp Cardiol 2009, 62:400-408.
24. Cohen J. Statistical power analysis for the behavioral sciences. Hillsdale, USA: Lawrence Erlbaum; 1988.
25. Verbeke G, Molenbergs M: Linear Mixed Models for Longitudinal Data. New York, USA: Springer; 2000.
26. Campbell MK, Elbourne DR, Altman DG: CONSORT statement: extension to cluster randomised trials. BMJ 2004, 328:702-708.
27. Takeda A, Taylor SJC, Taylor RS, Khan F, Krum H, Underwood M. Clinical service organisation for heart failure. Cochrane Database Syst Rev 2012, Issue 9.Art. No.:CD002752. doi:10.1002/14651858.CD002752.pub3.
28. McAlister FA, Stewart S, Ferrua S, McMurray JJJV: Multidisciplinary strategies for the management of heart failure patients at high risk for admission: A systematic review of randomized trials. J Am Coll Cardiol 2004, 44:810-819.
29. Cherubini AOJ: THe persistent exclusion of older patients from ongoing clinical trials regarding heart failure. Arch Intern Med 2011, 171:550-556.
30. Heiat AGC, Gross CP, Krumholz HM: Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med 2002, 162:1682-1688.
31. Cancian M, Battaggia A, Celebrano M, Del Zotti F, Novelletto BF, Michieli R, Saugo M, Pellizzari M, Toffanin R: The care for chronic heart failure by general practitioners. Results from a clinical audit in Italy. Eur J Gen Pract 2013, 19:3-10.
32. Perneger TV, Leplège A, Etter JF, Rougemont A: Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol 1995, 48:1051-1060.
33. Naveiro-Rilo JC, Diez-Juárez DM, Romero Blanco A, Rebollo-Gutiérrez F, Rodríguez-Martínez A, Rodríguez-García MA: Validation of the Minnesota living with heart failure questionnaire in primary care. Rev Esp Cardiol 2010, 63:1419-1427.
34. Garin O, Ferrer M, Pont A, Rué M, Kotzeva A, Wiklund I, Van Ganse E, Alonso J: Disease-specific health-related quality of life questionnaires for heart failure: a systematic review with meta-analyses. Qual Life Res 2009, 18:71-85.
35. Labrunée M, Pathak A, Loscos M, Coudeyre E, Casillas J-M, Gremeaux V: Therapeutic education in cardiovascular diseases: state of the art and perspectives. Ann Phys Rehabil Med 2012, 55:322-341.
36. Riegel B, Carlson B: Facilitators and barriers to heart failure self-care. Patient Educ Couns 2002, 46:287-295.
37. Prochaska JO, DiClemente CC: Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol 1983, 51:390-395.
38. Caisse nationale de l'assurance maladie [National heath care insurance]: Caractéristiques et trajet de soins des insuffisants cardiaques du régime général [Chronic heart failure patients: characteristics and continuity of patient care]. Points de repère 2012, 38:1-14.
39. Adamson J, Cockayne S, Puffer S, Torgerson DJ: Review of randomised trials using the post-randomised consent (Zelen's) design. Contemp Clin Trials 2006, 27:305-319.
40. Roethlisberger FJ, Dickson WJ, Wright A: Management and the worker: an account of a research program conducted by the Western Electric Company, Hawthorne Works, Chicago. Chicago: Harvard University Press; 1939.
41. Feise RJ: Do multiple outcome measures require p-value adjustment? BMC Med Res Methodol 2002, 2:8.