Therapeutic Education by Telemedicine in Chronic Heart Failure

NCT00878202 | Terminated Phase 4 DMC

• 1 other identifier: B80909-60
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Number of hospitalization days for heart failure

  12 months

Secondary Outcomes (10)

• 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

Study Arms (2)

Control

NO INTERVENTION

Optimal medical treatment of Heart failure and therapeutic education

Telemedicine

EXPERIMENTAL

Optimal medical treatment of heart failure disease and therapeutic education

Device: SCAD information system

Interventions

SCAD information system DEVICE

Clinical follow-up and continuation of therapeutic education by telemedicine during 3 months

Telemedicine

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (6)

Alençon-Mamers Hospital

Alençon, 61000, France

Location

Caen University Hospital

Caen, France

Location

Cherbourg Hospital

Cherbourg, France

Location

Flers Hospital

Flers, France

Location

Lisieux Hospital

Lisieux, 14100, France

Location

Saint-Lo Hospital

Saint-Lô, 50009, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rémi Sabatier, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

• Annette Belin, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 8, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

FR (6)