title: Telephone-based health coaching for chronically ill patients: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS) DRKS00000584.
authors.affiliation: Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistr 52, Hamburg 20246, Germany. s.dwinger@uke.de.
authors.forename: Sarah
authors.initials: S
authors.lastname: Dwinger
authors.forename: Jörg
authors.initials: J
authors.lastname: Dirmaier
authors.forename: Lutz
authors.initials: L
authors.lastname: Herbarth
authors.forename: Hans-Helmut
authors.initials: HH
authors.lastname: König
authors.forename: Matthias
authors.initials: M
authors.lastname: Eckardt
authors.forename: Levente
authors.initials: L
authors.lastname: Kriston
authors.forename: Isaac
authors.initials: I
authors.lastname: Bermejo
authors.forename: Martin
authors.initials: M
authors.lastname: Härter
mesh_terms: D002908:Chronic Disease / Q000191:economics / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D003376:Counseling / Q000191:economics; D005858:Germany; D015438:Health Behavior; D017048:Health Care Costs; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D057194:Intention to Treat Analysis; D009726:Nurses; D010359:Patient Readmission; D011446:Prospective Studies; D012107:Research Design; D017216:Telemedicine / Q000191:economics / Q000295:instrumentation*; D013689:Telephone / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome