ITMO public health
Last update : 03/06/2012 | Version : 1 | ID : 90
| General | |
| Identification | |
| Detailed name | Observatoire National sur la prise en charge thérapeutique en médecine de ville des patients de 65 ans et plus, présentant un diabète de type 2, une douleur chronique ou une fibrillation auriculaire |
| Sign or acronym | Les S.AGES |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | N° Enregistrement CNIL 09.045 - Date CPP 6 Février 2009 - Afssaps 23 Décembre 2008 |
| General Aspects | |
| Medical area |
General practice |
| Others (details) | Type-2 diabetes, Atrial Fibrillation, Chronic Pain |
| Keywords | Elderly subject observatories |
| Scientific investigator(s) (Contact) | |
| Name of the director | VIGNAL |
| Surname | Franck |
| Phone | +33 (0)1 57 63 26 47 |
| franck.vignal@sanofi.com | |
| Unit | Sanofi Aventis |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Sanofi-aventis France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-aventis France |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Describe the therapeutic care in general practice of patients aged 65 years and older having type-2 diabetes, chronic pain or atrial fibrillation. |
| Inclusion criteria |
▪ Man or woman ages 65 years and older residing in metropolitan ▪ Affiliated with a social security scheme or beneficiary of an equivalent scheme • Accepting to participate in the study and who have signed the consent form ▪ Having type-2 diabetes treated by oral diabetes medication and/or injectable diabetes medication (for the Diabetes observatory) ▪ Having or who has had in the 12 months preceding inclusion, a documented atrial fibrillation (AF) (by ECG or Holter ECG) regardless of the rhythm on the day of inclusion (for the Atrial Fibrillation observatory) ▪ Having a pain that has been evolving for more than 3 months, requiring care (for the Chronic Pain observatory) |
| Population type | |
| Age |
Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2014 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | in progress |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Place of living, Driving a motor vehicle, Paramedical and social care (beneficiary of ALD status (long-term affection), APA (Personal Autonomy Allowances), mutual, etc.) |
| Biological data (detail) | - Creatinine - HBA1C for the Diabetes observation |
| Administrative data (detail) | - Sex - Date of birth Level of education: primary, educational certificate, high school graduate, higher education - Current professional activity or date stopped - Social and occupational category - Marital status [single, living as a couple, divorced] |
| Presence of a biobank |
Yes |
| Contents of biobank |
DNA |
| Details of biobank content | Samples preserved for 15 years |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Collection of data for each of the visits, by the general practitioner, on an internet website devoted to each of the observatories. |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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This site complies with the HONcode standard for trustworthy health information: |
8 rue de la Croix Jarry 75013 Paris Phone : +33 1 44 23 67 47 |
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