Therapeutic Education by Telemedicine in Chronic Heart Failure

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: SCAD information system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalization days for heart failure |  | 12 months | 

Secondary Outcome Measures

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