ITMO public health
Last update : 07/22/2015 | Version : 2 | ID : 98
| General | |
| Identification | |
| Detailed name | Longitudinal study on patients with severe Crohn's disease that did not respond to treatment and who are initiating treatment with anti-TNF alpha |
| Sign or acronym | VISION |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°1379382 |
| General Aspects | |
| Medical area |
Gastroenterology et hepatology |
| Keywords | psychometric validation, questionnaire, satisfaction, patients, anti-TNF alpha |
| Scientific investigator(s) (Contact) | |
| Name of the director | Thibout |
| Surname | Emmanuel |
| Phone | +33 (0)1 45 60 13 69 |
| emmanuel.thibout@abbott.com | |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Abbott France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Abbott 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 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 selection of 30 gastroenterologists from a list of French gastroenterologists who follow and treat patients for their Crohn's disease |
| Database objective | |
| Main objective | Validate a new satisfaction questionnaire for patients with regards to their treatment with Anti TNF in Crohn's disease at a severe and evolving stage |
| Inclusion criteria | Patients suffering from severe and evolving Crohn's disease and who have not responded to the treatments despite a complete and adapted protocol of corticotherapy and/or an immunosuppressant or intolerant to such treatments or that have medical contraindications and who move to an anti TNF treatment |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | National |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2010 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 300 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Others |
| Other (detail) | Satisfaction questionnaire |
| Procedures | |
| Classifications used | CIM 10 |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 3 months of follow-up starting from patient inclusion |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-VISION |
| Description | List of publications in Pubmed |
| 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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