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

March 29, 2012
September 28, 2012
October 2011
September 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01696890 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Integration of Follow-up by First and Second Line Practitioners by Telemonitoring in Heart Failure.
Integration of Follow-up by First and Second Line Practitioners Facilitated by Telemonitoring Versus Stand-alone Telemonitoring in Patients With Severe Heart Failure

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Chronic Heart Failure
  • 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.
  • 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.
  • Active Comparator: integrated care
    telemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic.
    Intervention: Device: integrated follow-up
  • Active Comparator: standard care
    telemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic
    Intervention: Device: standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
60 Years to 90 Years
No
Contact: paul dendale, MD, PhD 0032 11 30 81 11 paul.dendale@jessazh.be
Belgium
 
NCT01696890
TEMAHF2
Yes
Paul Dendale, Jessa Hospital
Jessa Hospital
Not Provided
Principal Investigator: paul dendale, MD, PhD Jessa Hospital
Jessa Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP