[Observational study to evaluate the impact of an educational/informative intervention in the emotional status (anxiety) of patients with atopic dermatitis (CUIDA-DEL)].

INTRODUCTION One of the first therapeutic measures in atopic dermatitis should be the educational and informative approach about prophylactic aspects and evolution of the disease. This type of proceedings has been shown to be beneficial for the anxious type of emotional status in patients with atopic dermatitis. We evaluated the impact of an educational/informative intervention in the emotional status (anxiety) of patients with atopic dermatitis in Spain. MATERIAL AND METHODS Investigators were randomized into two study groups: the control group (CG) that followed current clinical practice and the intervention group (IG) that handed patients, in each visit, a booklet of information about different prophylactic aspects and care of atopic dermatitis. The duration of the study was 6 months with quarterly visits. All included patients had a diagnosis of atopic dermatitis. Anxiety was evaluated with the STAI anxiety questionnaire and clinical data regarding dermatological aspects (IGA, pruritus scale, location of the lesions) were also recorded. RESULTS A total of 1,247 patients were recruited thanks to the collaboration of 158 investigators. Patients were distributed as follows: 683 (54.7 %) in the CG and 564 (45.2 %) in the IG. Both group were homogeneous with respect to basal characteristics, and were constituted by 54 % of women with a mean age of 19 years. Eighty-six percent of atopic dermatitis lesions were preferentially located in extremities. Patients of both study groups showed improvement in their emotional status (trait and state anxiety) throughout the study with significant decreases in the STAI scores compared to basal ones. Regarding improvement in the questionnaire scores, no significant differences were observed between groups except in children aged 9 to 15 years, in the pediatric version of the STAI trait where the percentage of score decrease at 6 months adjusted to the basal score was 5.5 (19.0) for the CG and 10.6 (18.9) for the IG, (p < 0.05). A higher percentage of patients finished the study in the IG compared to the CG (83.1 % vs. 76.1 % p < 0.005). DISCUSSION AND CONCLUSIONS Although patients in the IG showed greater compliance with the follow-up of the study, the informative intervention about prophylactic aspects of atopic dermatitis designed in this study does not appear to have had an impact in improving the emotional status of adult patients.