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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014