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

Primary Purpose

Chronic Heart Failure

Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
integrated follow-up
standard care
Sponsored by
Jessa Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Heart Failure focused on measuring chronic heart failure, telemonitoring, first line practitioners, integrated approach, efficacy

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Middelheim Ziekenhuis
  • UZ Brussel
  • Ziekenhuis Oost-Limburg
  • AZ Maria Middelares
  • Jessa Hospital
  • AZ Groeninge
  • Chr.Citadelle

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

integrated care

standard care

Arm Description

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

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

Outcomes

Primary Outcome Measures

overall mortality
number of rehospitalizations
time investment by HF nurses

Secondary Outcome Measures

quality of life
appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)

Full Information

First Posted
March 29, 2012
Last Updated
April 6, 2015
Sponsor
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01696890
Brief Title
Integration of Follow-up by First and Second Line Practitioners by Telemonitoring in Heart Failure.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
lack of inclusions, sudden withdrawal of study coordinator
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jessa Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, telemonitoring, first line practitioners, integrated approach, efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
integrated care
Arm Type
Active Comparator
Arm Description
telemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic.
Arm Title
standard care
Arm Type
Active Comparator
Arm Description
telemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic
Intervention Type
Device
Intervention Name(s)
integrated follow-up
Intervention Description
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
Intervention Name(s)
standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall mortality
Time Frame
6 months
Title
number of rehospitalizations
Time Frame
6 months
Title
time investment by HF nurses
Time Frame
6 months
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
6 months
Title
appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
paul dendale, MD, PhD
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Middelheim Ziekenhuis
City
Antwerp
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Jessa Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
Country
Belgium
Facility Name
Chr.Citadelle
City
Liege
Country
Belgium

12. IPD Sharing Statement

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

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