Heart FailureMETISCARDIONCT01869452
Platform Therapeutic Education in Heart Failure and Coronary Disease
A study testing therapeutic education in people with Heart Failure and Acute Coronary Syndrome, run by Resicard at 4 sites in France.
Trial summary
A first therapeutic education is given before patient's discharge at the hospital, then a dedicated nurse follows patients through the phone,regularly according to patients' needs, continues to give advise on risk factors, information on medication and alert symptoms and therapeutic education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Coronary Syndrome, Coronary Bypass Graft Stenosis of Native Artery Graft
- What is being tested?
- therapeutic education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 4 sitesFrance
- Study dates
- May 2010to Jun 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalization for acute coronary syndrome (ST-segment elevation myocardial infarction ,no ST-segment elevation myocardial infarction ST , unstable angina)
- hospitalization for heart failure
- acute coronary syndrome < 3 months
- heart failure < 3 months
- coronary by-pass surgery < 3 months
Who cannot join
- complicated acute coronary syndrome (ventricular arrhythmia, heart failure, mechanical complications, cardiogenic shock)
- valvular cardiac pathology
- obstructive cardiomyopathy
- planned cardiac transplantation
- severe neurological or psychiatric troubles
- loss of autonomy
- other (refusal, language, nursing house, way of life not compatible with follow up, refusal of telephonic contacts)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Institut Coeur Effort Sante
Paris, 75005
Clinique Turin
Paris, 75008
Hopital Saint Antoine
Paris, 75012
Centre Cardiologique Alfred Kastler
Sarcelles, 95200
About this study
Official title: Telephonic Platform of Follow up, Therapeutical Education and Coordination in Secondary Prevention in Patients With Heart Failure and Coronary Disease
A first therapeutic education is given before patient's discharge at the hospital, then a dedicated nurse follows patients through the phone,regularly according to patients' needs, continues to give advise on risk factors, information on medication and alert symptoms and therapeutic education.
Read the detailed description
Patients are assigned to an arm accordingly to their needs: class 1 with light therapeutic education, class 2 with moderate education, class 3 with heavy education. Assignement is based on the first education diagnosis during hospitalization time.
Quality of life and patient's knowledge are regularly evaluated through questionnaires
- Conditions
- Heart Failure, Acute Coronary Syndrome, Coronary Bypass Graft Stenosis of Native Artery Graft
- Being tested
- therapeutic education
- Keywords
- education, risk factors, quality of life, coronary disease, telephone follow up, dedicated nurse
- Medical subject headings
- Heart Failure, Acute Coronary Syndrome, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic educationBehavioural
knowledge of disease, risk factors, diet, medication, alert symptoms
| Study group | Role | What they receive |
|---|---|---|
| therapeutic education class 1 | Other | patients in class 1 will have a follow up call with therapeutic education every 3 months. this is the light follow up. Receives: Behavioral: therapeutic education |
| therapeutic education class 2 | Other | patients in class 2 will have a follow up call with therapeutic education every month. this is the moderate follow up Receives: Behavioral: therapeutic education |
| therapeutic education class 3 | Other | patients in class 3 will have a follow up call with therapeutic education twice a month. this is the heavy follow up. Receives: Behavioral: therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patient with a better of quality of life
quality of life is evaluated with appropriate questionnaires
Measured: 1 year
Secondary outcomes (2)
number of patients who improve their knowledge of disease
Knowledge of disease includes risk factors, symptoms, medication, diet. It is evaluated with appropriate questionnaires.
Measured: 1 year
number of hospitalizations during the follow up
hospitalizations are recorded during the year of follow up, with cause and duration.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2010
- Primary completionJun 2013
- Study completionJun 2014
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resicard
- Sponsor type
- University, hospital or other
- Collaborators
- union nationale de formation et d'evaluation en medecine cardio-vasculaire
- Responsible party
- Principal investigator, Pr Ariel Cohen, Resicard
- Investigators
- ariel a cohen, md, Principal investigator, Resicard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869452
- Sponsor's protocol ID
- Platform
- Acronym
- METISCARDIO
- Status last verified
- May 2015
- First submitted
- 23 May 2013
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephonic Platform of Follow up, Therapeutical Education and Coordination in Secondary Prevention in Patients With Heart Failure and Coronary Disease
- ClinicalTrials.gov ID
- NCT01869452
- Acronym / sponsor ID
- METISCARDIO / Platform
- Conditions
- Heart Failure, Acute Coronary Syndrome, Coronary Bypass Graft Stenosis of Native Artery Graft
- Keywords
- education, risk factors, quality of life, coronary disease, telephone follow up, dedicated nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- ResicardUniversity, hospital or other
- Collaborators
- union nationale de formation et d'evaluation en medecine cardio-vasculaire
- Study start
- May 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Jun 2013 (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.
A first therapeutic education is given before patient's discharge at the hospital, then a dedicated nurse follows patients through the phone,regularly according to patients' needs, continues to give advise on risk factors, information on medication and alert symptoms and therapeutic education.
Detailed description
Patients are assigned to an arm accordingly to their needs: class 1 with light therapeutic education, class 2 with moderate education, class 3 with heavy education. Assignement is based on the first education diagnosis during hospitalization time.
Quality of life and patient's knowledge are regularly evaluated through questionnaires
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| therapeutic education class 1 | Other | Behavioral: therapeutic educationpatients in class 1 will have a follow up call with therapeutic education every 3 months. this is the light follow up. |
| therapeutic education class 2 | Other | Behavioral: therapeutic educationpatients in class 2 will have a follow up call with therapeutic education every month. this is the moderate follow up |
| therapeutic education class 3 | Other | Behavioral: therapeutic educationpatients in class 3 will have a follow up call with therapeutic education twice a month. this is the heavy follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- hospitalization for acute coronary syndrome (ST-segment elevation myocardial infarction ,no ST-segment elevation myocardial infarction ST , unstable angina)
- hospitalization for heart failure
- acute coronary syndrome < 3 months
- heart failure < 3 months
- coronary by-pass surgery < 3 months
Key exclusion criteria (7 listed)
- complicated acute coronary syndrome (ventricular arrhythmia, heart failure, mechanical complications, cardiogenic shock)
- valvular cardiac pathology
- obstructive cardiomyopathy
- planned cardiac transplantation
- severe neurological or psychiatric troubles
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 |
|---|---|---|
| therapeutic educationknowledge of disease, risk factors, diet, medication, alert symptoms | Behavioural | therapeutic education class 1, therapeutic education class 2, therapeutic education class 3 |
Primary outcome
number of patient with a better of quality of life
Time frame: 1 year
quality of life is evaluated with appropriate questionnaires
2 secondary outcomes
number of patients who improve their knowledge of disease
Time frame: 1 year
number of hospitalizations during the follow up
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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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.
ariel a cohen, md principal investigator
Resicard
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic education in people with Heart Failure and Acute Coronary Syndrome, run by Resicard at 4 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patient with a better of quality of life (time frame: 1 year). 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 5 May 2015.