Atopic Dermatitis, Psoriasis
Conditions
Keywords
Moderate and severe psoriasis and atopic dermatitis
Brief summary
'OnderHUIDs' is an educational program (Department of Dermatology, University Hospital, Gent) for patients with psoriasis and atopic dermatitis. We want to stimulate the patient to actively participate in their therapeutic approach by enhanced self care. We call the hypothesis that this program will help the patients learn to cope with their disease and to be loyal to their treatment, which will result in a better quality of life, better clinical outcome and cost effectiveness.
Interventions
BEHAVIORALeducation on skin disease conditions
information about several skin diseases skin function recommendation on care of skin
BEHAVIORALStress-reduction techniques
Physical Training yoga mindfulness-based stress reduction
BEHAVIORALLifestyle factors and psycho-education
by dietician and psychiatrist
standard care without educational program
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have given written informed consent * Women or men of any race * Patients who are 18-75 years of age * Diagnosis of psoriasis or atopic dermatitis
Exclusion criteria
* Patients with a cognitive disorder (not able to understand, speak, read or write..) * Patients with a significant underlying medical cause (i.e. severe infection, haematologic disease, malignity, severe renal or hepatic disease, major depression) in the last 3 months * Patients under experimental pharmaceutical medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of a novel educational program on the quality of life and the clinical outcome. | At 12 weeks, after 6 and 9 months | Therefore quality of life questionnaires are completed at the beginning of the program, at the end of the program (12 weeks), after 6 months and after 9 months. The quality of life questionnaires are Daily life quality index, Skindex 29, EuroQol -5D, Short Form - 36 , Psoriasis disability index, Quality of Life Index for Atopic Dermatitis. The clinical effectiveness is determined by measuring psoriasis area and severity index (PASI) or scoring atopic dermatitis (SCORAD) at the beginning of the program, at the end of the program (12 weeks), after 6 months and after 9 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression severity | At 12 weeks, 6 months and 9 months | Beck Depression Inventory (BDI) is a self-completed questionnaire with 21 questions. It is one of the most widely used instruments for measuring depression severity. BDI scores are collected during the four study visits. |
| Lifestyle | At 12 weeks, 6 months and 9 months | Patients are queried for changes in smoking behaviour and physical activity monthly. Also, stress is examined during the four study visits,therefore we use the Everyday Problem Checklist. |
| Medical consumption and cost-effectiveness evaluation | At 12 weeks, 6 months and 9 months | Medical therapy of patients is divided into: topical therapy, systemic therapy, combination of topical and systemic therapy or no therapy. Patients are asked for changes in medical therapy monthly. Also, medical consumption is followed: costs for medication and doctor visits related to the management of the skin disease. EuroQol-5D (EQ-5D) questionnaires are used as standardised instrument to measure health outcomes. For cost-utility analysis, gain in quality-adjusted life years utilities is plotted against time, using the area under the curve approach (cost in EUR/EQ-5D gain). |
Countries
Belgium
Outcome results
None listed