Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis

Conditions
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Psoriasis, Atopic Dermatitis

Intervention / Treatment
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* Behavioral: education on skin disease conditions
* Behavioral: Stress-reduction techniques
* Behavioral: Lifestyle factors and psycho-education
* Other: no educational program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: current therapy<br> | Other: no educational program<br>* standard care without educational program<br>|
| Experimental: current therapy with educational program<br> | Behavioral: education on skin disease conditions<br>* information about several skin diseases skin function recommendation on care of skin<br>Behavioral: Stress-reduction techniques<br>* Physical Training yoga mindfulness-based stress reduction<br>Behavioral: Lifestyle factors and psycho-education<br>* by dietician and psychiatrist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate and severe psoriasis and atopic dermatitis