Clinical trial NCT01696890: Integration of Follow-up by First and Second Line Practitioners by Telemonitoring in Heart Failure.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
telemonitoring
first line practitioners
integrated approach
efficacy
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients hospitalized for decompensation of systolic heart failure
* LVEF \< 40% during hospitalization.

Exclusion Criteria:

* reversible forms of acute heart failure (acute ischemia, myocarditis,..)
* heart failure due to severe aortic stenosis
* participation in cardiac rehabilitation after discharge
* previous or actual residency in a nursing home
* creatinine clearance \<15 ml/min
* planned dialysis in the next 6 months
* planned biventricular pacemaker or cardiac surgery
* life expectancy of less than 1 year due to other diseases
* severe obstructive pulmonary disease (Gold III)
* significant mental or cognitive problems interfering with the daily measurements or intake of medication.

Primary outcomes:
measure: overall mortality
timeFrame: 6 months
measure: number of rehospitalizations
timeFrame: 6 months
measure: time investment by HF nurses
timeFrame: 6 months
Secondary outcomes:
measure: quality of life
timeFrame: 6 months
measure: appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)
timeFrame: 6 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Middelheim Ziekenhuis
city: Brussel
country: Belgium
facility: UZ Brussel
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liege
country: Belgium
facility: Chr.Citadelle
Study officials:
affiliation: Jessa Hospital
name: paul dendale, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: