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'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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| current therapy | Placebo Comparator |
| |
| current therapy with educational program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| education on skin disease conditions | Behavioral | information about several skin diseases skin function recommendation on care of skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of a novel educational program on the quality of life and the clinical outcome. | 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. | At 12 weeks, after 6 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression severity | 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. | At 12 weeks, 6 months and 9 months |
| Lifestyle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Lambert, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | Belgium |
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| Label | URL |
|---|---|
| website University Hospital Ghent | View source |
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| Stress-reduction techniques | Behavioral | Physical Training yoga mindfulness-based stress reduction |
|
| Lifestyle factors and psycho-education | Behavioral | by dietician and psychiatrist |
|
| no educational program | Other | standard care without educational program |
|
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. |
| At 12 weeks, 6 months and 9 months |
| Medical consumption and cost-effectiveness evaluation | 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). | At 12 weeks, 6 months and 9 months |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D003876 | Dermatitis, Atopic |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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