Haut-Tief Patient Education on Psoriasis and Eczema

Study Overview
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Brief Summary
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'Haut-Tief' (Skin Deep) is an educational, stress reducing program for patients with psoriasis or atopic dermatitis. A range of support activities will be offered in order to learn effective self-management strategies and attitude to one's chronic skin disease and consequently improving quality of life.

Detailed Description
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The educational program consists of 2-hours of educational (dermatology, specialized nurse, psychologist) and stress-reduction sessions (yoga, meditation, physiotherapy) twice a week during 9 weeks. A multidisciplinary team of trainers is involved. Primary endpoint is the general and skin dependent quality of life measured by questionnaires. HRQoL (Health-Related Quality of Life) is measured at baseline, after 3 months, 6 months and 9 months follow up. Patients are recruited from the out-patient clinic at the Department of Dermatology of the University Hospital Zurich. Patients are randomized in an intervention and control group. Intervention group receives the education program additionally to follow-up visits whereas the control group receives follow-up visits. Several runs are planned.

Official Title
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A Prospective, Randomized, Controlled Study of the Impact of Education and Stress-reduction Techniques on Psoriasis and Eczema.

Conditions
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Psoriasis, Atopic Dermatitis/ Eczema

Intervention / Treatment
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* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic psoriasis (disease for more than 3 months) Chronic eczema (disease for more than 3) months) Age ≥ 18 years Oral and written informed consent Exclusion Criteria: systemic antiinflammatory therapy treatment with other investigational products other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc), known or suspected non-compliance, drug or alcohol abuse, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject participation in another study within the 30 days preceding and during the present study, (viii) previous enrollment into the current study, enrolment of the investigator, his/her family members, employees and other dependent persons.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months) | Behavioral: Control<br>* Regular follow-up and treatment WITHOUT behavioural intervention<br>|
| Active Comparator: Haut Tief patient education<br>patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months). | Behavioral: Control<br>* Regular follow-up and treatment WITHOUT behavioural intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in DLQI (Dermatology Life Quality Index) score [ ] | DLQI is a questionnaire measuring Health related quality of life 10 questions | baseline, 3 months, 6 months, 9 months | 
| change in Skindex-29 score [ ] | Questionnaire measuring Health related quality of life 29 questions | baseline, 3 months, 6 months, 9 months | 
| change in ShortForm 36 score [ ] | Questionnaire measuring Health related quality of life | baseline, 3 months, 6 months, 9 months | 
| change in EQ 5D score [ ] | Questionnaire measuring Health related quality of life | baseline, 3 months, 6 months, 9 months | 
| change in EQ VAS (EQ visual analogue scale) score [ ] | Questionnaire measuring Health related quality of life | baseline, 3 months, 6 months, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in EASI (eczema area and severity index) score [ ] | clinical score for atopic dermatitis | baseline, 3 months, 6 months, 9 months | 
| change in PASI (psoriasis area and severity index) [ ] | clinical score for psoriasis | baseline, 3 months, 6 months, 9 months | 
| BDI (Beck Depression Inventory) score [ ] |  | baseline, 3 months, 6 months, 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, atopic dermatitis, eczema, patient education, stress reduction, quality of life