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Therapeutic Education by Telemedicine in Chronic Heart Failure (SEDIC)

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00878202
First received: April 6, 2009
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Failure
 Device: SCAD information system
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Number of hospitalization days for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Total mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of hospitalization for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Median of time up to mortality or hospitalization for heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of medical consultation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pharmaco-economic analysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Disease knowledge questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life questionnaire ( Minnesota) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • BNP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Six minutes walk test [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: March 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Optimal medical treatment of Heart failure and therapeutic education
Experimental: Telemedicine
Optimal medical treatment of heart failure disease and therapeutic education
 Device: SCAD information system
Clinical follow-up and continuation of therapeutic education by telemedicine during 3 months

  Eligibility

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878202

Locations
France
Alençon-Mamers Hospital
Alençon, France, 61000
Caen University Hospital
Caen, France
Cherbourg Hospital
Cherbourg, France
Flers Hospital
Flers, France
Lisieux Hospital
Lisieux, France, 14100
Saint-Lo Hospital
Saint-Lo, France, 50009
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Rémi Sabatier, MD University Hospital, Caen
Principal Investigator: Annette Belin, MD University Hospital, Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT00878202     History of Changes
Other Study ID Numbers: B80909-60
Study First Received: April 6, 2009
Last Updated: February 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013