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1. Signs and symptoms of intimate partner violence in women attending primary care in Europe, North America and Australia: a systematic review and meta-analysis

Author

Catherine Laporte, Philippe Vorilhon, Bruno Pereira, Gilles Lazimi, Aurélie Cabaillot, Mathilde Vicard-Olagne, Laure Rougé, Département de Médecine Générale [Clermont-Ferrand], Faculté de Médecine - Clermont-Auvergne (FM - UCA), Université Clermont Auvergne (UCA)-Université Clermont Auvergne (UCA), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne (UCA), Département de Médecine Générale, Université Paris Cité (UPCité), Université de Paris (UP), and VIGNAL, Alexine

Subjects
medicine.medical_specialty, education, Sexually Transmitted Diseases, Intimate Partner Violence, CINAHL, Anxiety, 01 natural sciences, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, 030212 general & internal medicine, 0101 mathematics, Depression (differential diagnoses), [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Primary Health Care, business.industry, Public health, 010102 general mathematics, Odds ratio, Confidence interval, 3. Good health, Europe, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Family medicine, Meta-analysis, Domestic violence, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, medicine.symptom, Family Practice, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Background Intimate partner violence (IPV) is a prevalent yet underdiagnosed health issue, and primary care practitioners are in a unique front-line position to provide care and counsel for the victims. Objective To identify the signs and symptoms of women exposed to IPV who attended primary care, regardless motive of consultation. Methods Systematic review and meta-analysis on Cochrane, PubMed, Embase and CINAHL between 1946 and 2020. Eligible studies had to be original quantitative research, on women aged >15 years, attending primary care settings in Europe, North America and Australia and interviewed on their status as victims of IPV and on their signs and symptoms. Results Of 1791 articles identified, 57 were selected. Associations were found between IPV and signs and symptoms of depression [19 studies: overall odds ratio (OR) = 3.59, 95% confidence interval (CI; 2.7–4.7, I2 = 94.6%)], anxiety [9 studies: overall OR = 2.19, 95% CI (1.75–2.73, I2 = 84%)], gynaecological and/or sexually transmitted infections [6 studies: overall OR = 2.82, 95% CI (2.1–3.8, I2 = 41%)] and combination of somatic symptoms [5 studies: standard mean deviation = 0.795, 95% CI (0.62–0.97, I2 = 0%)]. Conclusions Women exposed to IPV may present with clinical symptoms and signs other than bodily injury. Policy implications knowing these symptoms presented by women victims of IPV can help GPs identify and treat them. Systematic review registration PROSPERO CRD42018089857.

Published
2021
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2. Inhibiteurs de la pompe à protons. Quelle est la meilleure méthode d'arrêt ?

Author

Richard, Amélie, AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne (UCA), and VIGNAL, Alexine

Subjects
[SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience

Published
2021

4. Development of the nursing science university field in France: National and international perspectives

Author

Elisabeth Noel‐hureaux, Laurent Visier, Sébastien Colson, Rémi Gagnayre, Brigitte Vennat, Anne Muller, VIGNAL, Alexine, Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS), Aix Marseille Université (AMU), Institutions et Dynamiques Historiques de l'Économie et de la Société (IDHES), Université Paris 1 Panthéon-Sorbonne (UP1)-Université Paris 8 Vincennes-Saint-Denis (UP8)-Université Paris Nanterre (UPN)-Université d'Évry-Val-d'Essonne (UEVE)-Centre National de la Recherche Scientifique (CNRS)-Ecole Normale Supérieure Paris-Saclay (ENS Paris Saclay), Centre d'Etudes Politiques Et sociaLes : Environnement, Santé, Territoires (CEPEL), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne (UCA), Centre de recherche interuniversitaire, Expérience, Ressources Culturelles, Education (EXPERICE), Université Paris 8 Vincennes-Saint-Denis (UP8)-Université Paris 13 (UP13)-Université de Pau et des Pays de l'Adour (UPPA)-Université Sorbonne Paris Nord, Laboratoire éducations et promotion de la santé (LEPS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Sorbonne Paris Nord, Ecole Normale Supérieure Paris-Saclay (ENS Paris Saclay)-Université d'Évry-Val-d'Essonne (UEVE)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Nanterre (UPN)-Université Paris 8 Vincennes-Saint-Denis (UP8)-Université Paris 1 Panthéon-Sorbonne (UP1), Université Paris 8 Vincennes-Saint-Denis (UP8)-Université de Pau et des Pays de l'Adour (UPPA)-LABEX ICCA, Université Paris 13 (UP13)-Université Sorbonne Nouvelle - Paris 3-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP)-Université Sorbonne Paris Nord-Université Paris 13 (UP13)-Université Sorbonne Nouvelle - Paris 3-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP)-Université Sorbonne Paris Nord-Université Sorbonne Paris Nord, and Laboratoire Educations et Pratiques de Santé (LEPS)

Subjects
Internationality, 030504 nursing, Universities, business.industry, Field (Bourdieu), [SDV]Life Sciences [q-bio], MEDLINE, Subject (documents), Nursing, Public relations, [SDV] Life Sciences [q-bio], 03 medical and health sciences, 0302 clinical medicine, Political science, Humans, Nursing science, 030212 general & internal medicine, France, 0305 other medical science, business, General Nursing, Professional community
Abstract

International audience; This reform, which allowed the creation of the CNU Nursing Sciences Section, recognizes and develops the careers of academics in the nursing sciences in France. This makes it possible to overcome the conditions of isolation in which some researchers find themselves, and finally move towards a professional community of researchers. This should be made possible as soon as French universities have Editorial note: Editorials are opinion pieces. This piece has not been subject to peer review and the opinions expressed are those of the authors.

Published
2021
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5. Efficacy of acetylleucine in vertigo and dizziness: a systematic review of randomised controlled trials

Author

Florian Naudet, Rémy Boussageon, Helene Vaillant Roussel, Nematollah Jaafari, Clara Blanchard, Denis Pouchain, Paul Vanderkam, Marie Christine Perault-Pochat, Département de Médecine Générale, Université de Poitiers (DMG), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers-Université de Poitiers, Unité de Recherche Clinique [CH Henri Laborit, Poitiers], Centre Hospitalier Henri Laborit (CHL), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Médecine Générale [CHRU Tours], Université Francois Rabelais [Tours]-Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), AutomédiCation aCcompagnement Pluriprofessionnel PatienT (ACCePPT), Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Departement Médecine Générale [Clermont-Ferrand] (UFR Médecine), Université d'Auvergne - Clermont-Ferrand I (UdA), Service de pharmacologie clinique et de sensibilisation [CHU Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Groupement de recherche en Psychiatrie (GDR Psychiatrie (3557)), Centre National de la Recherche Scientifique (CNRS), Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), VIGNAL, Alexine, Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Université Francois Rabelais [Tours]

Subjects
medicine.medical_specialty, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Treatment outcome, Pharmacology toxicology, MEDLINE, Placebo, 030226 pharmacology & pharmacy, Dizziness, MESH: Dizziness, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, law, Leucine, Vertigo, otorhinolaryngologic diseases, MESH: vertigo, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Medical prescription, Randomized Controlled Trials as Topic, Pharmacology, Randomised controlled trial, Acetylleucine, biology, business.industry, General Medicine, biology.organism_classification, 3. Good health, Physical therapy, MESH: Treatment outcome, MESH: Randomised controlled trial, business, MESH: Acetylleucine, medicine.drug
Abstract

International audience; PURPOSE:To assess the efficacy of acetylleucine to improve or stop an attack of vertigo and dizziness (vertigo/dizziness).METHODS:Systematic review by 2 independent reviewers. Consultation of the Medline, Cochrane and ClinicalTrials.gov databases until September 2018. Keywords used: Acetylleucine, Tanganil®, Acetyl-DL-leucine, Acetyl-leucine. Trial selection: randomised controlled trials (RCTs) comparing acetylleucine against placebo.RESULTS:Up until 2018, no RCTs have been published on the efficacy of acetylleucine in vertigo/dizziness.CONCLUSION:There is no solid evidence of the efficacy of acetylleucine in vertigo/dizziness. Given its frequent prescription and the cost generated for the French social security system, high-quality randomised trials should be carried out to assess its efficacy.

Published
2019
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6. Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial

Author

Gilles Clément, Catherine Laporte, Denis Pouchain, Bruno Pereira, Jean-François Chenot, Bénédicte Eschalier, Marion De Rosa, Philippe Vorilhon, Charles Vorilhon, Hélène Vaillant-Roussel, Romain Eschalier, Claude Dubray, CIC Clermont Ferrand, Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-Centre de Pharmacologie Clinique, Departement Médecine Générale [Clermont-Ferrand], Université d'Auvergne - Clermont-Ferrand I (UdA), Neuro-Psycho Pharmacologie des Systèmes Dopimanégiques sous-corticaux (NPsy-Sydo), CHU Clermont-Ferrand-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service de Cardiologie Maladies Vasculaires [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], Departement Médecine Générale [Tours] (Faculté de Médecine), Université de Tours (UT), Department of General Practice [Greifswald, Germany] (Institute of Community Medicine), Universität Greifswald - University of Greifswald, Périnatalité, grossesse, Environnement, PRAtiques médicales et DEveloppement (PEPRADE), CHU Clermont-Ferrand-Université d'Auvergne - Clermont-Ferrand I (UdA), This trial received public funding from the French hospital research funds, a grant from the French Ministry of Health (PHRC-Hospital Program of Clinical Research) and regional health agencies (URCAM and GRSP) and private funding from Sanofi-Aventis, ‘le Groupe Pasteur Mutualité’ (private medical insurance) and ‘Union Régionale des Médecins Libéraux de la Région Auvergne’ (regional primary care physician association)., VIGNAL, Alexine, and Université de Tours

Subjects
Quality of life, Male, medicine.medical_specialty, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Health Status, General Practice, 030204 cardiovascular system & hematology, Disease cluster, 03 medical and health sciences, 0302 clinical medicine, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Patient Education as Topic, Surveys and Questionnaires, medicine, Humans, 030212 general & internal medicine, Cluster randomised controlled trial, Aged, Aged, 80 and over, Heart Failure, Ejection fraction, Primary Health Care, business.industry, Stroke Volume, Patient education, Middle Aged, medicine.disease, Primary care, Mental health, 3. Good health, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Clinical trial, Mental Health, Heart failure, Chronic Disease, Physical therapy, Female, Family Practice, business, Research Article, Follow-Up Studies
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). Electronic supplementary material The online version of this article (doi:10.1186/s12875-016-0473-4) contains supplementary material, which is available to authorized users.

Published
2016
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7. General practitioners’ justifications for therapeutic inertia in cardiovascular prevention: an empirically grounded typology

Author

Jean-Pierre Lebeau, Denis Pouchain, Helene Vaillant-Roussel, Virginie Yaouanc, Isabelle Aubin-Auger, Emmanuel Rusch, Kristin Hendrickx, Jean Sébastien Cadwallader, Alain Mercier, Etienne Vermeire, Roy Remmen, Éducation Éthique Santé EA 7505 (EES), Université de Tours (UT), Departement Médecine Générale [Tours] (Faculté de Médecine), Departement Médecine Générale [Clermont-Ferrand], Université d'Auvergne - Clermont-Ferrand I (UdA), Centre Hospitalier de Vendôme, Recherche Clinique ville-hôpital, Méthodologies et Société (REMES), Université Paris Diderot - Paris 7 (UPD7), Departement Médecine Générale [Bobigny], Université Paris 13 (UP13)-UFR SMBH, Département de soins primaires et interdisciplinaires [Antwerpen, Belgium], University of Antwerp (UA), The study was an investigator-initiated one and was funded by unrestricted research grants from the French National College of Teachers in General Practice and Pierre Fabre Medicaments., EES Research Team [Tours] (Faculté de Médecine), Departement Médecine Générale [Tours], Université de Tours-Université de Tours, Université de Tours, UFR SMBH-Université Paris 13 (UP13), EES Research team [Tours] (Faculté de Médecine), Departement de Santé Publique [Tours], and VIGNAL, Alexine

Subjects
Adult, Male, Typology, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Evidence-based practice, [SDV]Life Sciences [q-bio], Applied psychology, education, Psychological intervention, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, PRIMARY CARE, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Humans, Medicine, 030212 general & internal medicine, Cluster randomised controlled trial, Practice Patterns, Physicians', Antihypertensive Agents, Data collection, business.industry, Research, General Medicine, Middle Aged, QUALITATIVE RESEARCH, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, 3. Good health, Primary Prevention, [SDV] Life Sciences [q-bio], Cardiovascular Diseases, Hypertension, Global Positioning System, Female, Human medicine, Clinical Competence, Guideline Adherence, Family Practice, business, Construct (philosophy), Qualitative research
Abstract

Objective To construct a typology of general practitioners’ (GPs) responses regarding their justification of therapeutic inertia in cardiovascular primary prevention for high-risk patients with hypertension. Design Empirically grounded construction of typology. Types were defined by attributes derived from the qualitative analysis of GPs’ reported reasons for inaction. Participants 256 GPs randomised in the intervention group of a cluster randomised controlled trial. Setting GPs members of 23 French Regional Colleges of Teachers in General Practice, included in the EffectS of a multifaceted intervention on CArdiovascular risk factors in high-risk hyPErtensive patients (ESCAPE) trial. Data collection and analysis The database consisted of 2638 written responses given by the GPs to an open-ended question asking for the reasons why drug treatment was not changed as suggested by the national guidelines. All answers were coded using constant comparison analysis. A matrix analysis of codes per GP allowed the construction of a response typology, where types were defined by codes as attributes. Initial coding and definition of types were performed independently by two teams. Results Initial coding resulted in a list of 69 codes in the final codebook, representing 4764 coded references in the question responses. A typology including seven types was constructed. 100 GPs were allocated to one and only one of these types, while 25 GPs did not provide enough data to allow classification. Types (numbers of GPs allocated) were: ‘optimists’ (28), ‘negotiators’ (20), ‘checkers’ (15), ‘contextualisers’ (13), ‘cautious’ (11), ‘rounders’ (8) and ‘scientists’ (5). For the 36 GPs that provided 50 or more coded references, analysis of the code evolution over time and across patients showed a consistent belonging to the initial type for any given GP. Conclusion This typology could provide GPs with some insight into their general ways of considering changes in the treatment/management of cardiovascular risk factors and guide design of specific physician-centred interventions to reduce inappropriate inaction. Trial registration number NCT00348855.

Published
2016
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8. Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial

Author

Bruno Pereira, Catherine Laporte, Denis Pouchain, Jean-Yves Le Reste, Claude Dubray, Gilles Clément, Jean-Pierre Lebeau, Philippe Vorilhon, Jean-François Chenot, Gilles Tanguy, Marc Ruivard, Jean Cassagnes, Hélène Vaillant-Roussel, Departement Médecine Générale [Clermont-Ferrand], Université d'Auvergne - Clermont-Ferrand I (UdA), Centre d'Investigation Clinique [CHU Clermont-Ferrand] (CIC 1405), Institut National de la Santé et de la Recherche Médicale (INSERM)-Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand-CHU Clermont-Ferrand, Neuro-Psycho Pharmacologie des Systèmes Dopimanégiques sous-corticaux (NPsy-Sydo), CHU Clermont-Ferrand-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Service de Cardiologie Maladies Vasculaires [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], Service de Médecine Interne [CHU Clermont-Ferrand], Departement Médecine Générale [Brest] (Faculté de Médecine), Université de Brest (UBO), Departement Médecine Générale [Tours] (Faculté de Médecine), Université de Tours (UT), Department of General Practice [Greifswald, Germany] (Institute of Community Medicine), Universität Greifswald - University of Greifswald, Périnatalité, grossesse, Environnement, PRAtiques médicales et DEveloppement (PEPRADE), CHU Clermont-Ferrand-Université d'Auvergne - Clermont-Ferrand I (UdA), This trial received public funding (105 750 euros, 52%) from the French hospital research fund, a grant from the French Ministry of Health (PHRC-Hospital Program of Clinical Research) and regional health agencies (URCAM and GRSP), and private funding (97 500 euros, 48%) from Sanofi-Aventis, ‘le Groupe Pasteur mutualité’ (private medical insurance), and ‘Union régionale des médecins libéraux de la région Auvergne’ (regional primary care physician association)., Université de Tours, and VIGNAL, Alexine

Subjects
Male, Quality of life, Cluster-randomised controlled trial, medicine.medical_specialty, [SDV.SP.MED] Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Heart disease, law.invention, Study Protocol, Randomized controlled trial, Patient Education as Topic, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, law, Medicine, Humans, Cluster randomised controlled trial, Disease management (health), 10. No inequality, Aged, Heart Failure, Primary Health Care, business.industry, Disease Management, Patient education, Middle Aged, medicine.disease, Primary care, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, 3. Good health, Clinical trial, Treatment Outcome, Heart failure, Chronic Disease, Physical therapy, Female, France, business, Family Practice
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. 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. Trial registration 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]. Electronic supplementary material The online version of this article (doi:10.1186/s12875-014-0208-3) contains supplementary material, which is available to authorized users.

Published
2014
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