GLOBAL AWARE
Research type
Research Study
Full title
Estimating the burden of illness in adult atopic dermatitis patients
IRAS ID
202868
Contact name
Andrew Pink
Contact email
Sponsor organisation
Sanofi
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
0 years, 1 months, 30 days
Research summary
The AWARE study is designed to collect information about patients who suffer from atopic dermatitis (AD). AD is the most common form of eczema and causes the skin to become itchy, red, dry and cracked. It is a long-term (chronic) condition for which there is no cure but there are a number of treatments.
Approximately 7,900 patients will participate in the patient survey (census) study in France (3,000), Germany (800), UK (1,800 at approximately 120 study sites), Spain (800), Italy (800) and Canada (700). A short survey, to be completed by the investigators, will capture demographic details and information about the patients’ AD management and treatments given during a period of between two to three weeks’ from the start of the site’s participation in the study.
More detailed information will be obtained during this study from between 1 – 6 patients per investigator (around 300 in the UK) who will complete a detailed Patient Reported Outcomes questionnaire capturing patient demographics, their opinion about their disease, mental state, impact on life choices, quality of life, amount of money spent on medication, satisfaction with treatment and details of support received. Other, open-ended questions will be asked to gain as much information possible. Information provided by the patients will remain confidential, the investigator and site staff will not see it. The investigators will capture data from the patient notes in a Case Report Form. It will record similar information to that from the survey of the 3,000 patients but in far more detail. Patients will be selected to ensure an even distribution across the severity of AD i.e. 100 patients in the mild, moderate and severe categories. Patients will provide informed consent prior to completing the Patient Reported Outcomes questionnaire.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0521
Date of REC Opinion
28 Sep 2016
REC opinion
Favourable Opinion