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

Chronic Heart Failure Clinical Trial

— TEMA-HF2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01696890
• Other study ID #: TEMAHF2
• Status: Terminated
• Phase: Phase 2
• First received: March 29, 2012
• Last updated: April 6, 2015
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Middelheim Ziekenhuis	Antwerp
Belgium	UZ Brussel	Brussel
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	AZ Maria Middelares	Gent
Belgium	Jessa Hospital	Hasselt
Belgium	AZ Groeninge	Kortrijk
Belgium	Chr.Citadelle	Liege

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall mortality		6 months	No
Primary	number of rehospitalizations		6 months	No
Primary	time investment by HF nurses		6 months	No
Secondary	quality of life		6 months	No
Secondary	appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)		6 months	No