Therapeutic Education by Telemedicine in Chronic Heart Failure

Heart Failure Clinical Trial

— SEDIC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00878202
• Other study ID #: B80909-60
• Status: Terminated
• Phase: Phase 4
• First received: April 6, 2009
• Last updated: February 19, 2013
• Start date: March 2009
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• SCAD information system
Clinical follow-up and continuation of therapeutic education by telemedicine during 3 months

Locations

Country	Name	City	State
France	Alençon-Mamers Hospital	Alençon
France	Caen University Hospital	Caen
France	Cherbourg Hospital	Cherbourg
France	Flers Hospital	Flers
France	Lisieux Hospital	Lisieux
France	Saint-Lo Hospital	Saint-Lo

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospitalization days for heart failure		12 months
Secondary	Cardiovascular mortality		12 months
Secondary	Total mortality		12 months
Secondary	Rate of hospitalization for heart failure		12 months
Secondary	Median of time up to mortality or hospitalization for heart failure		12 months
Secondary	Number of medical consultation		12 months
Secondary	Pharmaco-economic analysis		12 months
Secondary	Disease knowledge questionnaire		12 months
Secondary	Quality of life questionnaire ( Minnesota)		12 months
Secondary	BNP		12 months
Secondary	Six minutes walk test		12 months