Therapeutic Education by Telemedicine in Chronic Heart Failure (SEDIC)

Caen University Hospital

Status and phase: Terminated; Phase 4

Conditions: Heart Failure

Treatments: Device: SCAD information system

Study type: Interventional

Funder types: Other

Identifiers

NCT00878202

B80909-60

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 65 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control

No Intervention group

Description:

Optimal medical treatment of Heart failure and therapeutic education

Telemedicine

Experimental group

Description:

Optimal medical treatment of heart failure disease and therapeutic education

Treatment:

Device: SCAD information system