Therapeutic Education by Telemedicine in Chronic Heart Failure (SEDIC)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
SCAD information system
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- Alençon-Mamers Hospital
- Caen University Hospital
- Cherbourg Hospital
- Flers Hospital
- Lisieux Hospital
- Saint-Lo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Telemedicine
Arm Description
Optimal medical treatment of Heart failure and therapeutic education
Optimal medical treatment of heart failure disease and therapeutic education
Outcomes
Primary Outcome Measures
Number of hospitalization days for heart failure
Secondary Outcome Measures
Cardiovascular mortality
Total mortality
Rate of hospitalization for heart failure
Median of time up to mortality or hospitalization for heart failure
Number of medical consultation
Pharmaco-economic analysis
Disease knowledge questionnaire
Quality of life questionnaire ( Minnesota)
BNP
Six minutes walk test
Full Information
NCT ID
NCT00878202
First Posted
April 6, 2009
Last Updated
February 19, 2013
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT00878202
Brief Title
Therapeutic Education by Telemedicine in Chronic Heart Failure
Acronym
SEDIC
Official Title
Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Optimal medical treatment of Heart failure and therapeutic education
Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
Optimal medical treatment of heart failure disease and therapeutic education
Intervention Type
Device
Intervention Name(s)
SCAD information system
Intervention Description
Clinical follow-up and continuation of therapeutic education by telemedicine during 3 months
Primary Outcome Measure Information:
Title
Number of hospitalization days for heart failure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cardiovascular mortality
Time Frame
12 months
Title
Total mortality
Time Frame
12 months
Title
Rate of hospitalization for heart failure
Time Frame
12 months
Title
Median of time up to mortality or hospitalization for heart failure
Time Frame
12 months
Title
Number of medical consultation
Time Frame
12 months
Title
Pharmaco-economic analysis
Time Frame
12 months
Title
Disease knowledge questionnaire
Time Frame
12 months
Title
Quality of life questionnaire ( Minnesota)
Time Frame
12 months
Title
BNP
Time Frame
12 months
Title
Six minutes walk test
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi Sabatier, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annette Belin, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alençon-Mamers Hospital
City
Alençon
ZIP/Postal Code
61000
Country
France
Facility Name
Caen University Hospital
City
Caen
Country
France
Facility Name
Cherbourg Hospital
City
Cherbourg
Country
France
Facility Name
Flers Hospital
City
Flers
Country
France
Facility Name
Lisieux Hospital
City
Lisieux
ZIP/Postal Code
14100
Country
France
Facility Name
Saint-Lo Hospital
City
Saint-Lo
ZIP/Postal Code
50009
Country
France
12. IPD Sharing Statement
Learn more about this trial
Therapeutic Education by Telemedicine in Chronic Heart Failure
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