Haut-Tief Patient Education on Psoriasis and Eczema

University of Zurich (UZH)

Status: Unknown

Conditions: Psoriasis; Atopic Dermatitis/ Eczema

Treatments: Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02205593

Haut-Tief

Details and patient eligibility

About

'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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months)

Treatment:

Behavioral: Control

Haut Tief patient education

Active Comparator group

Description:

patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months).

Treatment:

Behavioral: Control