Clinical trial NCT02205593: Haut-Tief Patient Education on Psoriasis and Eczema
Official title: A Prospective, Randomized, Controlled Study of the Impact of Education and Stress-reduction Techniques on Psoriasis and Eczema.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Atopic Dermatitis/ Eczema
Keywords: psoriasis
atopic dermatitis
eczema
patient education
stress reduction
quality of life
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in DLQI (Dermatology Life Quality Index) score [ ]
timeFrame: baseline, 3 months, 6 months, 9 months
measure: change in Skindex-29 score [ ]
timeFrame: baseline, 3 months, 6 months, 9 months
measure: change in ShortForm 36 score [ ]
timeFrame: baseline, 3 months, 6 months, 9 months
measure: change in EQ 5D score [ ]
timeFrame: baseline, 3 months, 6 months, 9 months
measure: change in EQ VAS (EQ visual analogue scale) score [ ]
timeFrame: baseline, 3 months, 6 months, 9 months
Secondary outcomes:
measure: change in EASI (eczema area and severity index) score [ ]
timeFrame: baseline, 3 months, 6 months, 9 months
measure: change in PASI (psoriasis area and severity index) [ ]
timeFrame: baseline, 3 months, 6 months, 9 months
measure: BDI (Beck Depression Inventory) score [ ]
timeFrame: baseline, 3 months, 6 months, 9 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Dermatology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Dept. of Dermatology
name: Guenther Hofbauer, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: