French COAST - French Cost Of Acute STroke

Head :
BLIN Patrick, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Segalen Bordeaux
MOORE Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Segalen Bordeaux

Last update : 10/26/2017 | Version : 1 | ID : 2787

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Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
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 French Cost Of Acute STroke
Sign or acronym French COAST
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CCTI-RS 10.295, CNIL 910284
General Aspects
Medical area Neurology
Health determinants Medicine
Keywords Stroke, functional disability, fatigue, depression, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux
Collaborations
Funding
Funding status Private
Details Laboratoire Lundbeck (soutien inconditionnel) - Lundbeck (unconditional support)
Governance of the database
Sponsor(s) or organisation(s) responsible Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Segalen Bordeaux
Organisation status Public
Sponsor(s) or organisation(s) responsible Créativ-Ceutical
Organisation status Private
Scientific investigator(s) (Contact)
Name of the director BLIN
Surname Patrick
Address Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex
Phone 05 57 57 46 75
Email patrick.blin@u-bordeaux2.fr
Unit Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Segalen Bordeaux
Organization Université Bordeaux
Name of the director MOORE
Surname Nicholas
Address Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex
Phone 05 57 57 46 75
Email nicholas.moore@pharmaco.u-bordeaux2.fr
Unit Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Segalen Bordeaux
Organization Université Bordeaux
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. All patients admitted for a CI confirmed by imaging at the University Hospital of Bordeaux, Pellegrin hospital, are included in the study over a period of two months. Written consent of the patient or person of trust marks inclusion of the patient in the study
Database objective
Main objective The main objective is to determine the impact of the organization of acute care (medical, paramedical and therapeutic care) for patients with cerebral infarction on short and long term vital and functional prognosis.
Inclusion criteria Patient with a cerebral infarction confirmed by imaging (scan or MRI); not hospitalized for complications or side effects or for further assessment of a recent cerebral infarctionI; agreeing to participate and not affected by a language barrier.
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
Pathology I63 - Cerebral infarction
Gender Male
Woman
Geography area National
Detail of the geography area Bordeaux University Hospital – Pellegrin hospital
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2010
Date of last collection (YYYY or MM/YYYY) 2012
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 129 patients included
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Administrative data
Clinical data (detail) Direct physical measures
Declarative data (detail) Face to face interview
Phone interview
Details of collected declarative data HADS, FSS, EQ-5D, MRS scales, and questionnaire on resources use
Administrative data (detail) Patient name, first name, date and place of birth, phone number and address, contact details of the general practitioner.
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) Hospitalization
Medical/paramedical consultation
Medicines consumption
Quality of life/perceived health (detail) HADS, FSS, EQ-5D scales
Other (detail) Modified Rankin Scale
Procedures
Data collection method Data collection is performed through an eCRF by a Clinical Research Assistant at the Pellegrin hospital during the inclusion phase and by telephone during the follow-up phase.
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the participant (mail, e-mail, telephone etc.)
Details on monitoring of participants The follow-up is 12 months. Patients are contacted every 3 months to answer a telephone questionnaire (healthcare consumption since the last contact, scales on fatigue, depression, quality of life and functional disability). Vital status at one year included will be determined by the INSEE / INSERM procedure.
Links to administrative sources Yes
Linked administrative sources (detail) RNIPP (vital status)
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) The statistical analyses and study report were performed by Creativ-Ceutical.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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