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

NCT ID: NCT01696890

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

integrated care

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

Group Type: ACTIVE_COMPARATOR

integrated follow-up

Intervention Type: DEVICE

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.

standard care

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

Group Type: ACTIVE_COMPARATOR

standard care

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paul Dendale

Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

paul dendale, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

Middelheim Ziekenhuis

Antwerp, , Belgium

UZ Brussel

Brussels, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

AZ Maria Middelares

Ghent, , Belgium

Jessa Hospital

Hasselt, , Belgium

AZ Groeninge

Kortrijk, , Belgium

Chr.Citadelle

Liège, , Belgium

Countries

Belgium

Other Identifiers

TEMAHF2

Identifier Type: -

Identifier Source: org_study_id