Haut-Tief Patient Education on Psoriasis and Eczema

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

'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.

Study Overview

• Status: Unknown
• Conditions: Psoriasis; Atopic Dermatitis/ Eczema
• Intervention / Treatment: Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months)	Behavioral: Control; Regular follow-up and treatment WITHOUT behavioural intervention
Active Comparator: Haut Tief patient education; patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months).	Behavioral: Control; Regular follow-up and treatment WITHOUT behavioural intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in DLQI (Dermatology Life Quality Index) score [ ]	DLQI is a questionnaire measuring Health related quality of life 10 questions	baseline, 3 months, 6 months, 9 months
change in Skindex-29 score [ ]	Questionnaire measuring Health related quality of life 29 questions	baseline, 3 months, 6 months, 9 months
change in ShortForm 36 score [ ]	Questionnaire measuring Health related quality of life	baseline, 3 months, 6 months, 9 months
change in EQ 5D score [ ]	Questionnaire measuring Health related quality of life	baseline, 3 months, 6 months, 9 months
change in EQ VAS (EQ visual analogue scale) score [ ]	Questionnaire measuring Health related quality of life	baseline, 3 months, 6 months, 9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Guenther Hofbauer, Prof MD, University Hospital Zurich, Dept. of Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): October 1, 2018
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; atopic dermatitis; eczema; patient education; stress reduction; psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases, Papulosquamous; Hypersensitivity; Skin Diseases, Eczematous; Psoriasis; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: Haut-Tief

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No