Heart FailurePhase 4SEDICNCT00878202
Therapeutic Education by Telemedicine in Chronic Heart Failure
A Phase 4 study testing SCAD information system in people with Heart Failure, run by University Hospital, Caen at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- SCAD information system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesFrance
- Study dates
- Mar 2009to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Limited autonomy for device use
- Patient not living in Basse-Normandie
- Ongoing participation in another clinical trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Alençon-Mamers Hospital
Alençon, 61000
Caen University Hospital
Caen
Cherbourg Hospital
Cherbourg
Flers Hospital
Flers
Lisieux Hospital
Lisieux, 14100
Saint-Lo Hospital
Saint-Lô, 50009
About this study
Official title: Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.
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.
- Conditions
- Heart Failure
- Being tested
- SCAD information system
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCAD information systemDevice
Clinical follow-up and continuation of therapeutic education by telemedicine during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Optimal medical treatment of Heart failure and therapeutic education |
| Telemedicine | Experimental | Optimal medical treatment of heart failure disease and therapeutic education Receives: Device: SCAD information system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalization days for heart failure
Measured: 12 months
Secondary outcomes (10)
Cardiovascular mortality
Measured: 12 months
Total mortality
Measured: 12 months
Rate of hospitalization for heart failure
Measured: 12 months
Median of time up to mortality or hospitalization for heart failure
Measured: 12 months
Number of medical consultation
Measured: 12 months
Pharmaco-economic analysis
Measured: 12 months
Disease knowledge questionnaire
Measured: 12 months
Quality of life questionnaire ( Minnesota)
Measured: 12 months
BNP
Measured: 12 months
Six minutes walk test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémi Sabatier, MD, Principal investigator, University Hospital, CaenAnnette Belin, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878202
- Sponsor's protocol ID
- B80909-60
- Acronym
- SEDIC
- Status last verified
- Feb 2013
- First submitted
- 6 Apr 2009
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.
- ClinicalTrials.gov ID
- NCT00878202
- Acronym / sponsor ID
- SEDIC / B80909-60
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Optimal medical treatment of Heart failure and therapeutic education |
| Telemedicine | Experimental | Device: SCAD information systemOptimal medical treatment of heart failure disease and therapeutic education |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCAD information systemClinical follow-up and continuation of therapeutic education by telemedicine during 3 months | Device | Telemedicine |
Primary outcome
Number of hospitalization days for heart failure
Time frame: 12 months
10 secondary outcomes
Cardiovascular mortality
Time frame: 12 months
Total mortality
Time frame: 12 months
Rate of hospitalization for heart failure
Time frame: 12 months
Median of time up to mortality or hospitalization for heart failure
Time frame: 12 months
Number of medical consultation
Time frame: 12 months
Pharmaco-economic analysis
Time frame: 12 months
Disease knowledge questionnaire
Time frame: 12 months
Quality of life questionnaire ( Minnesota)
Time frame: 12 months
BNP
Time frame: 12 months
Six minutes walk test
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi Sabatier, MD principal investigator
University Hospital, Caen
Annette Belin, MD principal investigator
University Hospital, Caen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SCAD information system in people with Heart Failure, run by University Hospital, Caen at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospitalization days for heart failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013; AzTrials last refreshed its copy on 7 Nov 2026.