Dwinger Sarah, Dirmaier Jörg, Herbarth Lutz, König Hans-Helmut, Eckardt Matthias, Kriston Levente, Bermejo Isaac, Härter Martin
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistr 52, Hamburg 20246, Germany.
Trials. 2013 Oct 17;14:337. doi: 10.1186/1745-6215-14-337.
The rising prevalence of chronic conditions constitutes a major burden for patients and healthcare systems and is predicted to increase in the upcoming decades. Improving the self-management skills of patients is a strategy to steer against this burden. This could lead to better outcomes and lower healthcare costs. Health coaching is one method for enhancing the self-management of patients and can be delivered by phone. The effects of telephone-based health coaching are promising, but still inconclusive. Economic evaluations and studies examining the transferability of effects to different healthcare systems are still rare. Aim of this study is to evaluate telephone-based health coaching for chronically ill patients in Germany.
METHODS/DESIGN: The study is a prospective randomized controlled trial comparing the effects of telephone-based health coaching with usual care during a 4-year time period. Data are collected at baseline and after 12, 24 and 36 months. Patients are selected based on one of the following chronic conditions: diabetes, coronary artery disease, asthma, hypertension, heart failure, COPD, chronic depression or schizophrenia. The health coaching intervention is carried out by trained nurses employed by a German statutory health insurance. The frequency and the topics of the health coaching are manual-based but tailored to the patients' needs and medical condition, following the concepts of motivational interviewing, shared decision-making and evidence-based-medicine. Approximately 12,000 insurants will be enrolled and randomized into intervention and control groups. Primary outcome is the time until hospital readmission within two years after enrolling in the health coaching, assessed by routine data. Secondary outcomes are patient-reported outcomes like changes in quality of life, depression and anxiety and clinical values assessed with questionnaires. Additional secondary outcomes are further economic evaluations like health service use as well as costs and hospital readmission rates. The statistical analyses includes intention-to-treat and as-treated principles. The recruitment will be completed in September 2014.
This study will provide evidence regarding economic and clinical effects of telephone-delivered health coaching. Additionally, this study will show whether health coaching is an adequate option for the German healthcare system to address the growing burden of chronic diseases.
German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS) DRKS00000584.
慢性病患病率的不断上升给患者和医疗系统带来了重大负担,预计在未来几十年还会增加。提高患者的自我管理技能是应对这一负担的一项策略。这可能会带来更好的结果并降低医疗成本。健康指导是增强患者自我管理的一种方法,可以通过电话进行。基于电话的健康指导效果很有前景,但仍无定论。经济评估以及考察效果向不同医疗系统可转移性的研究仍然很少。本研究的目的是评估德国针对慢性病患者的基于电话的健康指导。
方法/设计:本研究是一项前瞻性随机对照试验,在4年时间内比较基于电话的健康指导与常规护理的效果。在基线以及12、24和36个月后收集数据。根据以下慢性病之一选择患者:糖尿病、冠状动脉疾病、哮喘、高血压、心力衰竭、慢性阻塞性肺疾病、慢性抑郁症或精神分裂症。健康指导干预由德国法定健康保险雇佣的经过培训的护士实施。健康指导的频率和主题以手册为基础,但根据动机性访谈、共同决策和循证医学的理念,针对患者的需求和医疗状况进行调整。大约12000名被保险人将被纳入并随机分为干预组和对照组。主要结局是在参加健康指导后两年内再次入院的时间,通过常规数据进行评估。次要结局是患者报告的结局,如生活质量、抑郁和焦虑的变化,以及通过问卷调查评估的临床指标。额外的次要结局是进一步的经济评估,如卫生服务利用以及成本和再次入院率。统计分析包括意向性分析和实际治疗分析原则。招募工作将于2014年9月完成。
本研究将提供有关基于电话的健康指导的经济和临床效果的证据。此外,本研究将表明健康指导是否是德国医疗系统应对日益增长的慢性病负担的合适选择。
德国临床试验注册中心(Deutsches Register Klinischer Studien;DRKS)DRKS00000584