Clinical trial NCT00878202: Therapeutic Education by Telemedicine in Chronic Heart Failure
Official title: Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of hospitalization days for heart failure
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 12 months
measure: Total mortality
timeFrame: 12 months
measure: Rate of hospitalization for heart failure
timeFrame: 12 months
measure: Median of time up to mortality or hospitalization for heart failure
timeFrame: 12 months
measure: Number of medical consultation
timeFrame: 12 months
measure: Pharmaco-economic analysis
timeFrame: 12 months
measure: Disease knowledge questionnaire
timeFrame: 12 months
measure: Quality of life questionnaire ( Minnesota)
timeFrame: 12 months
measure: BNP
timeFrame: 12 months
measure: Six minutes walk test
timeFrame: 12 months
Other outcomes:
Locations:
city: Alençon
country: France
facility: Alençon-Mamers Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Cherbourg
country: France
facility: Cherbourg Hospital
city: Flers
country: France
facility: Flers Hospital
city: Lisieux
country: France
facility: Lisieux Hospital
city: Saint-Lo
country: France
facility: Saint-Lo Hospital
Study officials:
affiliation: University Hospital, Caen
name: Rémi Sabatier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Annette Belin, MD
role: PRINCIPAL_INVESTIGATOR
References: