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Therapeutic Education by Telemedicine in Chronic Heart Failure

Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00878202
Acronym
SEDIC
Enrollment
100
Registered
2009-04-08
Start date
2009-03-31
Completion date
2012-06-30
Last updated
2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

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

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of hospitalization days for heart failure12 months

Secondary

MeasureTime frame
Total mortality12 months
Rate of hospitalization for heart failure12 months
Median of time up to mortality or hospitalization for heart failure12 months
Number of medical consultation12 months
Cardiovascular mortality12 months
Disease knowledge questionnaire12 months
Quality of life questionnaire ( Minnesota)12 months
BNP12 months
Six minutes walk test12 months
Pharmaco-economic analysis12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026