Therapeutic Education by Telemedicine in Chronic Heart Failure (SEDIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00878202
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : April 8, 2009
Last Update Posted : February 20, 2013
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: SCAD information system Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.
Study Start Date : March 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

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

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

Primary Outcome Measures :
  1. Number of hospitalization days for heart failure [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 12 months ]
  2. Total mortality [ Time Frame: 12 months ]
  3. Rate of hospitalization for heart failure [ Time Frame: 12 months ]
  4. Median of time up to mortality or hospitalization for heart failure [ Time Frame: 12 months ]
  5. Number of medical consultation [ Time Frame: 12 months ]
  6. Pharmaco-economic analysis [ Time Frame: 12 months ]
  7. Disease knowledge questionnaire [ Time Frame: 12 months ]
  8. Quality of life questionnaire ( Minnesota) [ Time Frame: 12 months ]
  9. BNP [ Time Frame: 12 months ]
  10. Six minutes walk test [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00878202

Alençon-Mamers Hospital
Alençon, France, 61000
Caen University Hospital
Caen, France
Cherbourg Hospital
Cherbourg, France
Flers Hospital
Flers, France
Lisieux Hospital
Lisieux, France, 14100
Saint-Lo Hospital
Saint-Lo, France, 50009
Sponsors and Collaborators
University Hospital, Caen
Principal Investigator: Rémi Sabatier, MD University Hospital, Caen
Principal Investigator: Annette Belin, MD University Hospital, Caen

Responsible Party: University Hospital, Caen Identifier: NCT00878202     History of Changes
Other Study ID Numbers: B80909-60
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases