Therapeutic Education by Telemedicine in Chronic Heart Failure (SEDIC)

February 19, 2013 updated by: University Hospital, Caen

Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.

The purpose of the SEDIC study is to test a home based heart failure patient clinical follow-up and therapeutic education using telemedicine. This educational follow-up is based on an interactive information system (SCAD) including a touch screen personal computer for heart failure patient at home. An interactive algorithm has been developed to allow a self management teaching to the patient.Furthermore, a specialized nurse provide a clinical data follow-up.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Alençon, France, 61000
        • Alençon-Mamers Hospital
      • Caen, France
        • Caen University Hospital
      • Cherbourg, France
        • Cherbourg Hospital
      • Flers, France
        • Flers Hospital
      • Lisieux, France, 14100
        • Lisieux Hospital
      • Saint-Lo, France, 50009
        • Saint-Lo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 95 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients > 65 years old hospitalized for acute heart failure
  • Left ventricle systolic Dysfunction with ejection fraction < 45 %, documented in the previous 6 months
  • And at least one of the following criteria:

BNP before discharge from hospital > 350 pg/ml / EF < 35 % / Hospitalization for acute heart failure informed in the previous 6 months

Exclusion Criteria:

  • NYHA 4 at hospital discharge
  • Planned cardiac surgery or coronary revascularization
  • Hospitalization for ST-elevation acute coronary syndrome
  • Depressive syndrome with score > 20 at geriatric depression scale
  • Therapeutic education impossible
  • Technical problems with the device
  • Limited autonomy for device use
  • Patient not living in Basse-Normandie
  • Ongoing participation in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Optimal medical treatment of Heart failure and therapeutic education
Experimental: Telemedicine
Optimal medical treatment of heart failure disease and therapeutic education
Device: SCAD information system
Clinical follow-up and continuation of therapeutic education by telemedicine during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of hospitalization days for heart failure
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Total mortality
Time Frame: 12 months
12 months
Cardiovascular mortality
Time Frame: 12 months
12 months
Rate of hospitalization for heart failure
Time Frame: 12 months
12 months
Median of time up to mortality or hospitalization for heart failure
Time Frame: 12 months
12 months
Number of medical consultation
Time Frame: 12 months
12 months
Pharmaco-economic analysis
Time Frame: 12 months
12 months
Disease knowledge questionnaire
Time Frame: 12 months
12 months
Quality of life questionnaire ( Minnesota)
Time Frame: 12 months
12 months
BNP
Time Frame: 12 months
12 months
Six minutes walk test
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Rémi Sabatier, MD, University Hospital, Caen
  • Principal Investigator: Annette Belin, MD, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 19, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B80909-60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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