ATHMOS - Validation of the ACT questionnaire in general practice ARCHIVE

Head :
Pribil Céline, Laboratoire GSK

Last update : 01/01/2018 | Version : 1 | ID : 166

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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 Validation of the ACT questionnaire in general practice
Sign or acronym ATHMOS
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL n°90 60 78 (12/05/2006)
General Aspects
Medical area Pneumology
Others (details) Asthma
Keywords asthma, control, "Asthma Control Test ©" (ACT)
Scientific investigator(s) (Contact)
Name of the director Pribil
Surname Céline
Phone +33 (0)1 39 17 90 62
Email celine.c.pribil@gsk.com
Unit Laboratoire GSK
Collaborations
Funding
Funding status Private
Details GSK laboratory
Governance of the database
Sponsor(s) or organisation(s) responsible Laboratoire GSK
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
An administrative base or a register
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Selection of GP:
A pre-selection via random drawing will be established using a CEGEDIM file of general practitioners.
The general practitioners pre-selected through the random drawing will receive a mailing which will briefly present the objectives of the study and how it will unfold. It will include a postage-paid response card to be returned to the logistics center indicating whether or not the practitioner wants to participate in the study
A telephone call to confirm participation will be made to the first 1000 general practitioners who have agreed

Selection of pneumologists:
A pre-selection via random drawing will be established using a CEGEDIM file of pneumologist/allergy doctors.
The pre-selected pneumologists/allergy doctors will be contacted by telephone (brief presentation of the objectives and the unfolding of the study) in the order of the preselection until the number of pneumologists/allergy doctors accepting to participate reaches 500.
The patients will be included after they have read the patient information letter
Database objective
Main objective Describe in actual practice the level of control of asthma using the ACT questionnaire (Asthma Control Test)
Inclusion criteria Male or female aged 18 years or older
Patient having asthma diagnosed at least 12 months ago
Patient informed of the objectives of the study and accepting the collection and the analysis of the data concerning him.
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 France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2006
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 2362
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Presence of a biobank No
Health parameters studied Health care consumption and services
Quality of life/health perception
Care consumption (detail) Hospitalization
Medical/paramedical consultation
Medicines consumption
Procedures
Data collection method The physician will complete the medical questionnaire for inclusion and will give the inclusion self-questionnaire to the patient. During the 3-month inclusion period, the investigating physicians must collect in a data register patients who are not included in the cohort, that meet the eligibility criteria but who cannot or do not want to participate in the study. The patients included will be examined again at the next spontaneous consultation which will also be a follow-up visit within the framework of the study where a follow-up questionnaire will be completed by the investigator and a follow-up self-questionnaire will be given to the patient
Participant monitoring Yes
Details on monitoring of participants spontaneous consultation following the inclusion during which will be completed a medical follow-up questionnaire and a follow-up self-questionnaire
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Publications in progress
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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