I-NORM - Management by French General Practitioners of uncontrolled hypertensive patients treated by dual therapy ARCHIVE

Head :
Herrmann Marie-Annick, Bristol-Myers Squibb
Schmidely Nathalie, Bristol-Myers Squibb

Last update : 01/01/2018 | Version : 1 | ID : 133

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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
Email 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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