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Randomized Controlled Trial
. 2016 Jul 19:17:80.
doi: 10.1186/s12875-016-0473-4.

Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial

Hélène Vaillant-Roussel  1   2 , Catherine Laporte  3   4 , Bruno Pereira  5 , Marion De Rosa  3 , Bénédicte Eschalier  3 , Charles Vorilhon  6 , Romain Eschalier  6 , Gilles Clément  3 , Denis Pouchain  7 , Jean-François Chenot  8 , Claude Dubray  9 , Philippe Vorilhon  3   10
Affiliations
Randomized Controlled Trial

Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial

Hélène Vaillant-Roussel et al. BMC Fam Pract. .

Abstract

Background: The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial aimed to determine whether a pragmatic education intervention in general practice could improve the quality of life of patients with chronic heart failure (CHF) compared with routine care.

Results: This cluster randomised controlled clinical trial included 241 patients with CHF attending 54 general practitioners (GPs) in France and involved 19 months of follow-up. The GPs in the Intervention Group were trained during a 2-day interactive workshop to provide a patient education programme. The mean age of the patients was 74 years (±10.5), 62 % were men and their mean left-ventricular ejection fraction was 49.3 % (± 14.3). At the end of the follow-up period, the mean Minnesota Living with Heart Failure Questionnaire scores in the Intervention and Control Groups were 33.4 (± 22.1) versus 27.2 (± 23.3; P = 0.74, intra-cluster coefficient [ICC] = 0.11). At the end of the follow-up period, the 36-Item Short Form Health Survey (mental health and physical health) scores in the Intervention and Control Groups were 58 (± 22.1) versus 58.7 (± 23.9; P = 0.58, ICC = 0.01) and 52.8 (± 23.8) versus 51.6 (± 25.5; P = 0.57, ICC = 0.01), respectively.

Conclusions: Patient education delivered by GPs to elderly patients with stable heart failure in the ETIC programme did not achieve an improvement in their quality of life compared with routine care. Further research on improving the quality of life and clinical outcomes of elderly patients with CHF in primary care is necessary.

Trial registration: The Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial is a cluster randomised controlled trial registered with ClinicalTrials.gov (

Registration number: NCT01065142 ) and the French Drug Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé;

Registration number: 2009-A01142-55).

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

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Figures

Fig. 1
Fig. 1
General practitioner and patient flow chart. GP, general practitioner; Min, minimum; Max, maximum
Fig. 2
Fig. 2
Changes in quality of life from baseline to the follow-up period for each Short Form 36 variable. IG, Intervention Group; CG, Control Group; Short form 36 physical health variables: PF, physical function; RP, role physical; BP, body pain; GH, general health. Short form 36 mental health variables: VT, vitality; RE, role emotional; MH, mental health; SF, social function. Short Form 36 variables are described at baseline (M0) and at 7, 13 and 19 months (M7, M13 and M19)
Fig. 3
Fig. 3
Cumulative number of patients with acute heart failure. IG, Intervention Group; CG, Control Group; HF, Heart Failure. Assessment at 4, 7, 10, 13 and 19 months (M4, M7, M10, M13 and M19). A case of acute heart failure was defined as an acute episode reported by the general practitioner with or without hospitalisation
Fig. 4
Fig. 4
Evolution of New York Heart Association stages during follow-up. IG, Intervention Group; CG, Control Group. New York Heart Associations stage assessment at baseline (M0) and at 7, 13 and 19 months (M7, M13 and M19)
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