title: First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT.
abstract: BACKGROUND
  Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage.
  
  
  METHODS
  Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva®). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months.
  
  
  RESULTS
  A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances.
  
  
  CONCLUSIONS
  CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02293252 ; date of registration: 10 November 2014.
authors.affiliation: Institute for Healthcare Management and Health Sciences, University of Bayreuth, Prieserstraße 2, 95444, Bayreuth, Germany. reiner.hofmann@uni-bayreuth.de.
authors.forename: Reiner
authors.initials: R
authors.lastname: Hofmann
authors.affiliation: Rehabilitation Center for Internal Medicine, Klinik am See, Seebad 84, 15562, Rüdersdorf, Germany. heinz.voeller@klinikamsee.com.|Center of Rehabilitation Research, University of Potsdam, Am Neuen Palais 10, 14469, Potsdam, Germany. heinz.voeller@klinikamsee.com.
authors.forename: Heinz
authors.initials: H
authors.lastname: Völler
authors.affiliation: Institute for Healthcare Management and Health Sciences, University of Bayreuth, Prieserstraße 2, 95444, Bayreuth, Germany. klaus.nagels@uni-bayreuth.de.
authors.forename: Klaus
authors.initials: K
authors.lastname: Nagels
authors.affiliation: Institute for Healthcare Management and Health Sciences, University of Bayreuth, Prieserstraße 2, 95444, Bayreuth, Germany. dominik.bindl@uni-bayreuth.de.
authors.forename: Dominik
authors.initials: D
authors.lastname: Bindl
authors.affiliation: Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. e.vettorazzi@uke.uni-hamburg.de.
authors.forename: Eik
authors.initials: E
authors.lastname: Vettorazzi
authors.affiliation: Institute for Healthcare Management and Health Sciences, University of Bayreuth, Prieserstraße 2, 95444, Bayreuth, Germany. ronny.dittmar@bdc.de.|Professional Board of German Surgeons, Luisenstraße 58/59, 10117, Berlin, Germany. ronny.dittmar@bdc.de.
authors.forename: Ronny
authors.initials: R
authors.lastname: Dittmar
authors.affiliation: Institute for Healthcare Management and Health Sciences, University of Bayreuth, Prieserstraße 2, 95444, Bayreuth, Germany. walter.wohlgemuth@klinik.uni-regensburg.de.|Radiology, University Medical Center of Regensburg, Franz-Josef-Strauß-Allee 11, 93053, Regensburg, Germany. walter.wohlgemuth@klinik.uni-regensburg.de.
authors.forename: Walter
authors.initials: W
authors.lastname: Wohlgemuth
authors.affiliation: Clinic for Cardiology, University Hospital Essen, Hufelandstraße 55, 45147, Essen, Germany. till.neumann@uk-essen.de.
authors.forename: Till
authors.initials: T
authors.lastname: Neumann
authors.affiliation: Comprehensive Heart Failure Center Würzburg and Department of Internal Medicine I, University of Würzburg, Straubmühlweg 2a, 97078, Würzburg, Germany. stoerk_s@ukw.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Störk
authors.affiliation: Contilia Heart and Vascular Center, Department of Cardiology and Angiology, Elisabeth Hospital Essen, Klara-Kopp-Weg 1, 45138, Essen, Germany. o.bruder@contilia.de.
authors.forename: Oliver
authors.initials: O
authors.lastname: Bruder
authors.affiliation: Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. k.wegscheider@uke.uni-hamburg.de.
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
authors.affiliation: Institute for Healthcare Management and Health Sciences, University of Bayreuth, Prieserstraße 2, 95444, Bayreuth, Germany. eckhard.nagel@uni-bayreuth.de.
authors.forename: Eckhard
authors.initials: E
authors.lastname: Nagel
authors.affiliation: Department of Medicine/Cardiology, German Heart Institute Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. fleck@dhzb.de.
authors.forename: Eckart
authors.initials: E
authors.lastname: Fleck
mesh_terms: D000368:Aged; D002908:Chronic Disease; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005260:Female; D005858:Germany; D017048:Health Care Costs; D006333:Heart Failure / Q000175:diagnosis / Q000191:economics* / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006699:Home Care Services / Q000191:economics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010359:Patient Readmission; D011237:Predictive Value of Tests; D011446:Prospective Studies; D058998:Remote Sensing Technology / Q000191:economics*; D012107:Research Design; D017216:Telemedicine / Q000191:economics* / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome