Atopic Dermatitis/ Eczema, Psoriasis
Conditions
Keywords
psoriasis, atopic dermatitis, eczema, patient education, stress reduction, quality of life
Brief summary
'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
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.
Interventions
BEHAVIORALControl
Regular follow-up and treatment WITHOUT behavioural intervention
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in ShortForm 36 score [ ] | baseline, 3 months, 6 months, 9 months | Questionnaire measuring Health related quality of life |
| change in EQ VAS (EQ visual analogue scale) score [ ] | baseline, 3 months, 6 months, 9 months | Questionnaire measuring Health related quality of life |
| change in DLQI (Dermatology Life Quality Index) score [ ] | baseline, 3 months, 6 months, 9 months | DLQI is a questionnaire measuring Health related quality of life 10 questions |
| change in Skindex-29 score [ ] | baseline, 3 months, 6 months, 9 months | Questionnaire measuring Health related quality of life 29 questions |
| change in EQ 5D score [ ] | baseline, 3 months, 6 months, 9 months | Questionnaire measuring Health related quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in PASI (psoriasis area and severity index) [ ] | baseline, 3 months, 6 months, 9 months | clinical score for psoriasis |
| BDI (Beck Depression Inventory) score [ ] | baseline, 3 months, 6 months, 9 months | — |
| change in EASI (eczema area and severity index) score [ ] | baseline, 3 months, 6 months, 9 months | clinical score for atopic dermatitis |
Countries
Switzerland
Outcome results
None listed