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

This study is currently recruiting participants.
Verified September 2012 by Jessa Hospital
Sponsor:
Information provided by (Responsible Party):
Paul Dendale, Jessa Hospital
ClinicalTrials.gov Identifier:
NCT01696890
First received: March 29, 2012
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Heart Failure
 Device: integrated follow-up
Device: standard care
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Jessa Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
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)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696890

Contacts
Contact: paul dendale, MD, PhD 0032 11 30 81 11 paul.dendale@jessazh.be

Locations
Belgium
Middelheim Ziekenhuis Recruiting
Antwerp, Belgium
Contact: Gilles Dekeulenaer, MD, PhD            
Principal Investigator: Gilles Dekeulenaer, MD, PhD            
UZ Brussel Recruiting
Brussel, Belgium
Contact: Caroline Weytjens, MD, PhD            
Principal Investigator: Caroline Weytjens, MD, PhD            
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium
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            
Jessa Hospital Recruiting
Hasselt, Belgium, 3500
Principal Investigator: paul dendale, MD, PhD            
AZ Groeninge Recruiting
Kortrijk, Belgium
Contact: Ivan Elegeert, MD            
Principal Investigator: Ivan Elegeert, MD            
Chr.Citadelle Recruiting
Liege, Belgium
Contact: Pierre Troisfontaines, MD            
Principal Investigator: pierre troisfontaines, MD            
Sponsors and Collaborators
Jessa Hospital
Investigators
Principal Investigator: paul dendale, MD, PhD Jessa Hospital
  More Information

No publications provided

Responsible Party: Paul Dendale, Prof Dr, Jessa Hospital
ClinicalTrials.gov Identifier: NCT01696890     History of Changes
Other Study ID Numbers: TEMAHF2
Study First Received: March 29, 2012
Last Updated: September 28, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Jessa Hospital:
chronic heart failure
telemonitoring
first line practitioners
integrated approach
efficacy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013