Integration of Follow-up by First and Second Line Practitioners by Telemonitoring in Heart Failure. (TEMA-HF2)
Recruitment status was Recruiting
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.
Chronic Heart Failure
Device: integrated follow-up
Device: standard care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- overall mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- number of rehospitalizations [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- time investment by HF nurses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: integrated care
telemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic.
Device: integrated follow-up
close interaction between HF clinic and general practitioner in response to telemonitoring alerts. All subjects will be monitored daily for heart rate, blood pressure, and body weight, after which these data are transferred automatically to the general practitioner. This device is custom-made.
Active Comparator: standard care
telemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic
Device: standard care
no interaction between HF clinic and general practitioner in response to telemonitoring alerts. General practitioner is responsible for adaptations to therapy according to clinical presentation of the patient.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696890
|Contact: paul dendale, MD, PhD||0032 11 30 81 firstname.lastname@example.org|
|Contact: Gilles Dekeulenaer, MD, PhD|
|Principal Investigator: Gilles Dekeulenaer, MD, PhD|
|Contact: Caroline Weytjens, MD, PhD|
|Principal Investigator: Caroline Weytjens, MD, PhD|
|Contact: Wilfried Mullens, MD, PhD|
|Principal Investigator: wilfried mullens, MD, PhD|
|AZ Maria Middelares||Recruiting|
|Gent, Belgium, 9000|
|Contact: Johan DeSutter, MD, PhD|
|Principal Investigator: Johan Desutter|
|Hasselt, Belgium, 3500|
|Principal Investigator: paul dendale, MD, PhD|
|Contact: Ivan Elegeert, MD|
|Principal Investigator: Ivan Elegeert, MD|
|Contact: Pierre Troisfontaines, MD|
|Principal Investigator: pierre troisfontaines, MD|
|Principal Investigator:||paul dendale, MD, PhD||Jessa Hospital|