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

University of Zurich2 个研究点分布在 1 个国家目标入组 80 人开始时间: 2012年7月最近更新: 2019年7月26日

适应症

干预措施

试验速览

阶段: 不适用
发起方: University of Zurich
入组人数: 80
试验地点: 2
主要终点: change in DLQI (Dermatology Life Quality Index) score [ ]

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

'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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Chronic psoriasis (disease for more than 3 months)
•Chronic eczema (disease for more than 3) months)
•Age ≥ 18 years
•Oral and written informed consent

排除标准

•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.

研究组 & 干预措施

Control

Placebo Comparator

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

干预措施: Control (Behavioral)

Haut Tief patient education

Active Comparator

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

干预措施: Control (Behavioral)