Haut-Tief Patient Education on Psoriasis and Eczema

Not Applicable

• Conditions: Atopic Dermatitis/ Eczema; Psoriasis
• Interventions: Behavioral: Control

• Registration Number: NCT02205593
• Lead Sponsor: University of Zurich

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2018-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months)
Haut Tief patient education	Control	patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months).

Primary Outcome Measures

Name	Time	Method
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 VAS (EQ visual analogue scale) score [ ]	baseline, 3 months, 6 months, 9 months	Questionnaire measuring Health related quality of life
change in ShortForm 36 score [ ]	baseline, 3 months, 6 months, 9 months	Questionnaire measuring Health related quality of life
change in EQ 5D score [ ]	baseline, 3 months, 6 months, 9 months	Questionnaire measuring Health related quality of life

Secondary Outcome Measures

Name	Time	Method
change in EASI (eczema area and severity index) score [ ]	baseline, 3 months, 6 months, 9 months	clinical score for atopic dermatitis
BDI (Beck Depression Inventory) score [ ]	baseline, 3 months, 6 months, 9 months
change in PASI (psoriasis area and severity index) [ ]	baseline, 3 months, 6 months, 9 months	clinical score for psoriasis

Trial Locations

Locations (1)

University Hospital Zurich, Department of Dermatology; 🇨🇭 Zurich, ZH, Switzerland