EVALADD - Follow-Up of a Cohort of Subjects with Behavioural Addiction and Starting Treatment at the Nantes University Hospital Addiction Treatment Department
Head :
Grall-Bronnec Marie , Addiction Treatment and Psychiatry Liaison Department/Clinical Investigation Unit (CIU) 18 (Nantes University Department): Behavioural Addictions and Complex Mood Disorders; EA 4275 SPHERE: Biostatistics, Pharmacoepidemiology and Subjective Measures in Health Sciences — Nantes University
Last update : 08/17/2016 | Version : 1 | ID : 73239
| General | |
| Identification | |
| Detailed name | Follow-Up of a Cohort of Subjects with Behavioural Addiction and Starting Treatment at the Nantes University Hospital Addiction Treatment Department |
| Sign or acronym | EVALADD |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | GNEDS: 04/02/2012 — CCTIRS: 21/11/2012 — CNIL: 09/10/2013 |
| General Aspects | |
| Medical area |
Psychology and psychiatry |
| Health determinants |
Addictions Healthcare system and access to health care services Lifestyle and behavior Social and psychosocial factors |
| Keywords | behavioural addition, psychiatric comorbidities, personality, impulsiveness, treatment |
| Scientific investigator(s) (Contact) | |
| Name of the director | Grall-Bronnec |
| Surname | Marie |
| Address | Service d’Addictologie et de Psychiatrie de Liaison - Bâtiment Louis Philippe - Hôpital St Jacques - 85 rue Saint-Jacques - 44093 NANTES Cedex 1 |
| Phone | + 33 (0)2 40 84 61 16 |
| marie.bronnec@chu-nantes.fr | |
| Unit | Addiction Treatment and Psychiatry Liaison Department/Clinical Investigation Unit (CIU) 18 (Nantes University Department): Behavioural Addictions and Complex Mood Disorders; EA 4275 SPHERE: Biostatistics, Pharmacoepidemiology and Subjective Measures in Health Sciences — Nantes University |
| Organization | Nantes University Hospital |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | EA 4275 SPHERE: Biostatistics, Pharmacoepidemiology and Subjective Measures in Health Sciences — Nantes University |
| Funding | |
| Funding status |
Public |
| Details | PHRC 2011 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Nantes University Hospital - Federative Institute of Behavioral Addictions (IFAC) - Behavioural Addictions and Complex Mood Disorders Unit |
| Organisation status |
Public |
| Presence of scientific or steering committees |
No |
| 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 is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
A cohort was created on 17/11/2015 that included:
232 pathological gambling patients; 62 excessive-gaming patients; 90 sex addiction patients; 370 patients with eating disorders; 29 patients with various behavioural addictions (work, clairvoyants, market trading, etc.). |
| Database objective | |
| Main objective | The main aim is to better understand the specific factors of addiction (risk factors for the onset of the disorder, prognostic factors related to disorder trajectory), and to improve therapeutic strategies and preventative actions. We also seek to develop several lines of research based on the concept of “Patient-Centered Outcomes Research”, putting the patient at each stage of the research process, which specifically apply to our area of activity (patient preferences, quality of life, etc.). |
| Inclusion criteria | The cohort population consisted of patients covered by a social security scheme; who are over 16 years old and beginning treatment for behavioural addition at the Addiction Treatment and Psychiatry Liaison Department at Nantes University Hospital. Patients must meet the diagnostic criteria for one of the behavioural addictions included in the study and given their informed consent to be included in the cohort. Legal representatives (parents, guardians, etc.) must also give their consent for minors and legally incompetent adults. Patient with higher mental function disorders or difficulty reading and writing in French, as well as patients under guardianship are not included in the study. |
| Population type | |
| Age |
Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Pays de la Loire |
| Detail of the geography area | Patients mainly from Nantes and the Pays de la Loire region. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | Open-longitudinal study |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 780 |
| 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 Face to face interview Phone interview |
| Details of collected declarative data | A multi-axial, systemic, standardised and comprehensive clinical assessment is carried out on each patient at baseline, at 6 months and 1 year, and annually thereafter if the patient agrees (indefinite duration). Data collected during these interviews include data that are common to all behavioural addictions (sociodemographic characteristics, history, psychiatric and addictive comorbidities, life events, compliance data) and data specifically related to each addiction (diagnosis and measurement of disorder severity, behaviour characteristics, behavioural function and other associated characteristics). |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Written self-administered questionnaires completed by patients prior to face-to-face interview; — Written heteroquestionnaires completed during face-to-face interview. |
| Quality procedure(s) used | The evaluator ensures that the self-administered questionnaire is properly completed during the face-to-face interview — Heteroquestionnaires are entered in an e-CRF by a secretary. Consistency checks are carried out on the e-CRF, and data entry verification is conducted on 10% of records entered. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | This assessment is carried out in parallel with clinical treatment. It shall be updated, if the patient agrees, at 6 months, 1 year and then all subsequent years that the patient continues, or does not continue, treatment within the department. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://je.anaqol.org/index.php?file=editonecontrat.php&idcontratr=49 |
| Access | |
| Presence of document that lists variables and coding procedures |
No |
| Terms of data access (charter for data provision, format of data, availability delay) |
To be decided if data may be used by academic teams.
Data may not be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
