Therapeutic Education by Telemedicine in Chronic Heart Failure (SEDIC)

C

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)

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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