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首页> 外文期刊>BMC Family Practice >Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial
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Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial

机译：初级保健（ETIC）中慢性心力衰竭的患者教育及其对患者生活质量的影响：一项整群随机试验的设计

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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 webcite , 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].
机译：背景技术由于人口老龄化以及心脏病检测和管理的改善，慢性心力衰竭正在增加。据估计，在法国59岁以上的全科患者中，这一患病率约为10％。这项研究的主要目的是通过在初级保健中涉及患者和全科医生（GP）教育的复杂干预措施来改善心力衰竭患者的生活质量。方法采用随机，整群对照试验，对法国奥弗涅地区的4个地区进行分层，比较干预组和对照组。纳入标准为：50岁以上的纽约心脏协会（NYHA）I，II或III期心力衰竭，射血分数降低或射血分数保留的患者。心律失常应由患者的心脏病专家根据欧洲心脏病学会指南标准进行确认。排除标准包括：严重的认知障碍，居住在机构中，参加另一项临床试验，患有NYHA IV期心力衰竭或缺乏法语技能。复杂的干预措施包括在GP诊所进行培训，并进行为期2天的互动研讨会，以提供患者的教育计划。全科医生受过执行病例管理，生活方式咨询和动机访谈的培训，以就临床警报信号，身体活动，饮食和心血管危险因素等主要主题对患者进行教育。试验开始后的第1、4、7、10、13和19个月安排了患者的教育课程。要评估的主要结果是对生活质量的影响，这是使用两份调查表确定的：明尼苏达州心衰患者生存问卷和SF-36。为了检测19个月时的平均生活质量差异，我们预计将从80名全科医生中至少研究400名患者。讨论该试验将提供有关对心力衰竭患者进行教育的复杂干预措施的有效性的见解，包括为期2天的GP研讨会和患者教育计划，以设置GP咨询以改善慢性心力衰竭患者的生活质量。此复杂的干预工具可用于初始和进一步的医学培训。试验注册ETIC是一项在ClinicalTrials.gov [NCT01065142网站，2010年2月8日]和法国药物管理局[SécuritéduMédicamentet des produits desanté;注册号：2009-A01142-55，2010年3月5日]。

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