ITMO public health
Last update : 08/17/2016 | Version : 1 | ID : 5007
| General | |
| Identification | |
| Detailed name | Cohort of Haematological Patients Admitted to Intensive Care: Long-Term Quality of Life |
| Sign or acronym | TRIAL-OH |
| General Aspects | |
| Medical area |
Hematology |
| Health determinants |
Healthcare system and access to health care services Lifestyle and behavior Social and psychosocial factors |
| Keywords | long term, haematology, intensive care, assessment, quality of life |
| Scientific investigator(s) (Contact) | |
| Name of the director | Azoulay |
| Surname | Elie |
| Address | Service de réanimation, Hôpital Saint-Louis, Paris |
| Phone | +33 (0)1 42 49 94 21 |
| Elie.azoulay@sls.aphp.fr | |
| Unit | UMR S-717, Prof. Sylvie Chevret |
| Organization | Intensive care department, Saint-Louis Hospital |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Hospital Clinical Research Programme (PHRC); French Society of Intensive Care Nurses; Ministry of Health |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Saint-Louis Hospital |
| Organisation status |
Public |
| 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 care professionals A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | To assess long-term quality of life (at 1 and 2 years) for haematology patients that survived ICU admission and to model the outcome of this following discharge from ICU. |
| Inclusion criteria | Patients with leukaemia, lymphoma and multiple myeloma in 17 departments throughout France and Belgium. |
| 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 |
International |
| Detail of the geography area | France and Belgium |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2010 |
| Date of last collection (YYYY or MM/YYYY) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1,376 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Details of collected clinical data | Disease status and treatment, Sepsis-Related Organ Failure Assessment (SOFA) score, performance index, comorbidity, etiological diagnoses. |
| Declarative data (detail) |
Phone interview |
| Details of collected declarative data | Quality of life (SF-36) |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization |
| Procedures | |
| Data collection method | 500 surviving patients at day 90 and their friends or relatives (one person per patient, most often the spouse) will be contacted 12 to 15 months following discharge from ICU to complete the following questionnaires: SF-36 (36 questions on quality of life), Hospital Anxiety and Depression Scale (14 questions on depressive and anxiety symptoms) and Impact of Event Scale (22 questions on post-traumatic stress). Patients admitted to hospital at time of contact will be contacted again 15 days following discharge from hospital. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | At 1 and 2 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://jco.ascopubs.org/content/31/22/2810.long |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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