ITMO public health
Last update : 01/01/2018 | Version : 1 | ID : 133
| General | |
| Identification | |
| Detailed name | Management by French General Practitioners of uncontrolled hypertensive patients treated by dual therapy |
| Sign or acronym | I-NORM |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N° 833542 version 16 |
| General Aspects | |
| Medical area |
Cardiology |
| Others (details) | high blood pressure |
| Keywords | High blood pressure, uncontrolled hypertension, dual therapy, therapeutic strategy, care, hypertension |
| Scientific investigator(s) (Contact) | |
| Name of the director | Herrmann |
| Surname | Marie-Annick |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| marie-annick.herrmann@bms.com | |
| Unit | Bristol-Myers Squibb |
| Name of the director | Schmidely |
| Surname | Nathalie |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| nathalie.schmidely@bms.com | |
| Unit | Bristol-Myers Squibb |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Bristol-Myers Squibb France / Sanofi-Aventis France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Bristol-Myers Squibb France (BMS) |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
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 |
| Additional information regarding sample selection. | random sampling in clusters |
| Database objective | |
| Main objective | Describe medical strategies used by general practitioners for uncontrolled hypertension despite dual-therapy: the I-NORM survey |
| Inclusion criteria |
Register: Patient>=18 years, seen in routine consultation, monitored for HBP, known for more than 3 months, treated via fixed or free dual therapy for his HBP, dual therapy initiated by the participating doctor or the corresponding specialist. Study: pt from the register, uncontrolled HBP (SBP >=140 mmhg and /or DBP>=90mmhg all comer pt or SBP >=130 mmhg and /or DBP>=80mmhg diabetic pt or with kidney failure), not participating into a clinical trial |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) 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 | Metropolitain France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2007 |
| Date of last collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 25211 : - Registre: 21208 - Etude: 4003 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Phone interview |
| Administrative data (detail) | questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Care consumption (detail) |
Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Paper CRF |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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