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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

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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
Published in
Trials, August 2015
DOI 10.1186/s13063-015-0886-8
Pubmed ID
Authors

Reiner Hofmann, Heinz Völler, Klaus Nagels, Dominik Bindl, Eik Vettorazzi, Ronny Dittmar, Walter Wohlgemuth, Till Neumann, Stefan Störk, Oliver Bruder, Karl Wegscheider, Eckhard Nagel, Eckart Fleck, on behalf of the CardioBBEAT Investigators

Abstract

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. 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. 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. 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. ClinicalTrials.gov NCT02293252 ; date of registration: 10 November 2014.

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The data shown below were compiled from readership statistics for 296 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Netherlands 2 <1%
United Kingdom 1 <1%
United States 1 <1%
Cyprus 1 <1%
Unknown 291 98%

Demographic breakdown

Readers by professional status Count As %
Student > Master 59 20%
Student > Ph. D. Student 39 13%
Researcher 30 10%
Student > Bachelor 22 7%
Student > Doctoral Student 19 6%
Other 42 14%
Unknown 85 29%
Readers by discipline Count As %
Medicine and Dentistry 70 24%
Nursing and Health Professions 45 15%
Psychology 23 8%
Social Sciences 11 4%
Computer Science 8 3%
Other 43 15%
Unknown 96 32%