Integration of Follow-up by First and Second Line Practitioners by Telemonitoring in Heart Failure. (TEMA-HF2)

Jessa Hospital

Status and phase: Terminated; Phase 2

Conditions: Chronic Heart Failure

Treatments: Device: integrated follow-up; Device: standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT01696890

TEMAHF2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

integrated care

Active Comparator group

Description:

telemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic.

Treatment:

Device: integrated follow-up

standard care

Active Comparator group

Description:

telemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic

Treatment:

Device: standard care