Therapeutic Education by Telemedicine in Chronic Heart Failure

NCT ID: NCT00878202

Last Updated: 2013-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Optimal medical treatment of Heart failure and therapeutic education

Group Type NO_INTERVENTION

No interventions assigned to this group

Telemedicine

Optimal medical treatment of heart failure disease and therapeutic education

Group Type EXPERIMENTAL

SCAD information system

Intervention Type DEVICE

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

Interventions

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SCAD information system

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rémi Sabatier, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Annette Belin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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Alençon-Mamers Hospital

Alençon, , France

Site Status

Caen University Hospital

Caen, , France

Site Status

Cherbourg Hospital

Cherbourg, , France

Site Status

Flers Hospital

Flers, , France

Site Status

Lisieux Hospital

Lisieux, , France

Site Status

Saint-Lo Hospital

Saint-Lô, , France

Site Status

Countries

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France

Other Identifiers

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B80909-60

Identifier Type: -

Identifier Source: org_study_id

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