ETHICCAR - Case-Control Study on Individual and Collective Therapeutic Education for At-Risk Cardiovascular Patients in General Medicine
Head :
Gay Bernard, U 897 - Département de Médecine Générale
Demeaux Jean-Louis, U 897 - Département de Médecine Générale
Demeaux Jean-Louis, U 897 - Département de Médecine Générale
Last update : 07/08/2015 | Version : 1 | ID : 8543
| General | |
| Identification | |
| Detailed name | Case-Control Study on Individual and Collective Therapeutic Education for At-Risk Cardiovascular Patients in General Medicine |
| Sign or acronym | ETHICCAR |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL approval no. 908457 received 02/11/2009 - CCTIRS favourable opinion received 18/04/2008. |
| General Aspects | |
| Medical area |
Cardiology Psychology and psychiatry |
| Health determinants |
Addictions Lifestyle and behavior Nutrition Social and psychosocial factors |
| Keywords | therapeutic, individual, collective, profile, psychosocial, cardiovascular risk, nutrition, alcohol, tobacco, physical activity |
| Scientific investigator(s) (Contact) | |
| Name of the director | Gay |
| Surname | Bernard |
| Address | Departement de Médecine Générale Université Bordeaux Segalen - Case 148 - 146 rue Léo Saignat 33076 Bordeaux cedex |
| Phone | +33 (0)5 57 57 12 77 |
| bernard.gay@u-bordeaux.fr | |
| Unit | U 897 - Département de Médecine Générale |
| Organization | Université de |
| Name of the director | Demeaux |
| Surname | Jean-Louis |
| Address | Departement de Médecine Générale Université Bordeaux Segalen - Case 148 - 146 rue Léo Saignat 33076 Bordeaux cedex |
| Phone | +33 (0)5 57 57 12 77 |
| jean-louis.demeaux@u-bordeaux.fr | |
| Unit | U 897 - Département de Médecine Générale |
| Organization | Université de |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | URCAM Aquitaine (FNPEIS), Regional Public Health Bodies, HAS, INPES. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Université de Bordeaux |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | INSERM |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control study |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at group level (clusters) |
| Additional information regarding sample selection. | 102 general practitioners, with an average of 3 patients for each, were randomly selected across 6 clusters in Aquitaine (Carto Santé URCAM). Patients are selected as such: first 3 patients eligible for the study who agreed to participate (patient register kept). |
| Database objective | |
| Main objective |
To assesses the impact of therapeutic education on reducing the risk and/or cardiovascular morbidity and mortality for hypertensive patients compared to regular follow-up.
Secondary objectives: - To describe the development of cardiovascular risk score in the three groups over 5 years: individual education, collective education and control group (regular follow-up); - To compare morbidity and mortality in the 3 groups; - To compare the impact of individual or collective action against standard follow-up; - To compare the results of individual action to collective action; - To analyse the psychosocial profile of respondents to either method; - To identify factors justifying the choice of either method or association; - To describe and compare the quality of life of patients in the 3 groups. |
| Inclusion criteria |
Inclusion criteria:
- Men over 50 and women over 60 years old (<75 years old); - Individuals with essential arterial hypertension (systolic pressure ≥140 mmHg, diastolic pressure ≥90 mmHg); - With another risk factor: smoking, diabetes, dyslipidemia (i.e., at least 3 cardiovascular risk factors); - No history of cardiovascular accident (primary prevention). Exclusion criteria: - Previous history of cardiovascular accident; - Secondary arterial hypertension; - Type 1 diabetes; - Short-term life-threatening disease; - Social or cultural situation making educational process impossible; - Cannot be monitored for at least two years; - Patient included in another study that could affect treatment (cohort study, therapeutic trial, etc.). |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Aquitaine Limousin Poitou-Charentes |
| Detail of the geography area | Aquitaine |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 188 patients included: 66 in the collective action group, 68 in the individual action group and 54 in the control group. |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Cardiovascular events, Body Mass Index, echocardiography. |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Medical questionnaire: smoking, alcohol, physical activity, medication, quality of life. |
| Biological data (detail) | -- |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception Others |
| Care consumption (detail) |
Medicines consumption |
| Other (detail) | Cardiovascular risk score. |
| Procedures | |
| Data collection method | D0, D0 + 6 months, D0 + 12 months, D0 + 24 months, D0 + 36 months, D0 + 48 months, D0 + 60 months. |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.researchgate.net/publication/233842679_Education_thrapeutique_du_patient_en_mdecine_gnrale._Ltude_ETHICCAR__faisabilit_et_valuation_chez_le_patient__risque_cardiovasculaire |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
