St and ardised description of the telemonitoring algorithm can expedite the identification of key components in telemonitoring algorithms that allow accurate prediction of worsening heart failure
Introduction : Non-invasive telemonitoring programmes detecting deterioration of heart failure are increasingly used in heart failure care .
Aim : The aim of this study was to compare different monitoring algorithms used in non-invasive telemonitoring programmes for patients with chronic heart failure .
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
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 r and omly 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 r and omization , 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 prospect i ve 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 r and omized 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 . Trial registration Clinical Trials.gov NCT02293252 ; date of registration : 10 November
St and ardised description of the telemonitoring algorithm can expedite the identification of key components in telemonitoring algorithms that allow accurate prediction of worsening heart failure
Introduction : Non-invasive telemonitoring programmes detecting deterioration of heart failure are increasingly used in heart failure care .
Aim : The aim of this study was to compare different monitoring algorithms used in non-invasive telemonitoring programmes for patients with chronic heart failure .