First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure – CardioBBEATReportar como inadecuado




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 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 16:343

First Online: 11 August 2015Received: 26 November 2014Accepted: 24 July 2015DOI: 10.1186-s13063-015-0886-8

Cite this article as: Hofmann, R., Völler, H., Nagels, K. et al. Trials 2015 16: 343. doi:10.1186-s13063-015-0886-8

Abstract

BackgroundEvidence 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.

MethodsBetween 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.

ResultsA 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.

ConclusionsCardioBBEAT 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.

Trial registrationClinicalTrials.gov NCT02293252; date of registration: 10 November 2014

KeywordsHome telemonitoring Chronic heart failure CHF Incremental Cost-Effectiveness Ratio ICER Mortality Telemedicine Health economics AbbreviationsACEangiotensin converting enzyme

AEadverse event

AHAAmerican Heart Association, staging of heart failure

ARBangiotensin receptor blocker

BMIbody mass index

CHFchronic heart failure

CIconfidence interval

CMcardiomyopathy

COPDchronic obstructive pulmonary disease

CRT-Dcardiac resynchronization therapy combined with defibrillation

DSLDigital Subscriber Line broadband connection

ECGelectrocardiogram

eCRFelectronic Case Report Form

ESCEuropean Society of Cardiology

GFRglomerular filtration rate

GPgeneral practitioner

HFheart failure

ICDimplantable cardioverter defibrillator

ICERIncremental Cost-Effectiveness Ratio

INHInterdisciplinary Network for Heart failure study

KCCQKansas City Cardiomyopathy Questionnaire with 23 items for measuring disease-specific domains in CHF

LBBBleft bundle branch block

LVEDDleft ventricular end-diastolic dimension

LVEFleft ventricular ejection fraction

MRmineralocorticoid receptor

MWDminute walking distance

n.a.not available

NYHANew York Heart Association, classification of heart failure

PADperipheral arterial disease

RBBBright bundle branch block

RCTrandomized controlled trial

SAEserious adverse event

SF-36v2short form health survey with 36 questions using norm-based scoring

TELE-HFTelemonitoring in patients with Heart Failure trial

TIAtransient ischemic attack

TIM-HFTelemedical Interventional Management in Heart Failure trial

UMTSUniversal Mobile Telecommunications System mobile cellular system

WHO-5World Health Organization Five, well-being index

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Autor: Reiner Hofmann - Heinz Völler - Klaus Nagels - Dominik Bindl - Eik Vettorazzi - Ronny Dittmar - Walter Wohlgemuth - Till 

Fuente: https://link.springer.com/







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