Chronic Heart Failure Clinical Trial
Official title:
Integration of Follow-up by First and Second Line Practitioners Facilitated by Telemonitoring Versus Stand-alone Telemonitoring in Patients With Severe Heart Failure
The aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.
The incidence of acute decompensated heart failure is increasing. Patients with severe heart
failure are rehospitalised for decompensation several times each year, increasing the cost
for health care. In these cases of recurrent decompensation, the medical intervention in
hospital is often limited to increasing the dosage of diuretics or vasodilators until the
patient reaches a compensated state. After discharge, a readmission can be expected within a
few months. A multidisciplinary approach by primary physician, heart failure nurse,
rehabilitation team and cardiologist has been shown to decrease rehospitalisation rate and
increase quality of life.
Very recently, our study group showed that an intense collaboration between first line
practitioner and heart failure clinic, facilitated by the use of telemonitoring, can reduce
mortality and hospitalisation rate. This study was a RIZIV sponsored trial of 6 months
follow-up in patients with chronic heart failure. However, a large randomised multicentre
trial investigating the use of telemonitoring in a population of heart failure (NYHA II-III)
patients did not find any difference between telemonitoring and usual care (Chaudry et al
NEJM 2010). In contradiction with this study, a Cochrane meta-analysis (Ingliss 2010) in
more than 5000 patients confirmed our finding with a reduction in mortality and morbidity.
The question therefore remains which factors are responsible for success or failure of the
use of telemonitoring. Based on our previous experience, the approach of close monitoring by
telemonitoring, with first line intervention by the patient's general practitioner (GP) and
supervision by the heart failure clinic, might be the critical success factor.
Therefore, the aim of this study is to evaluate this model of telemonitoring-assisted close
supervision and interaction between first and second line health professionals versus a
model of telemonitoring without this integrated approach.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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