Haut-Tief Patient Education on Psoriasis and Eczema

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02205593
• Other study ID #: Haut-Tief
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2012
• Est. completion date: December 2022

Study information

• Verified date: July 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis/ Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Intervention

Behavioral:
• Control
Regular follow-up and treatment WITHOUT behavioural intervention

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Department of Dermatology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change in Skindex-29 score [ ]	Questionnaire measuring Health related quality of life 29 questions	baseline, 3 months, 6 months, 9 months
Primary	change in ShortForm 36 score [ ]	Questionnaire measuring Health related quality of life	baseline, 3 months, 6 months, 9 months
Primary	change in EQ 5D score [ ]	Questionnaire measuring Health related quality of life	baseline, 3 months, 6 months, 9 months
Primary	change in EQ VAS (EQ visual analogue scale) score [ ]	Questionnaire measuring Health related quality of life	baseline, 3 months, 6 months, 9 months
Secondary	change in EASI (eczema area and severity index) score [ ]	clinical score for atopic dermatitis	baseline, 3 months, 6 months, 9 months
Secondary	change in PASI (psoriasis area and severity index) [ ]	clinical score for psoriasis	baseline, 3 months, 6 months, 9 months
Secondary	BDI (Beck Depression Inventory) score [ ]		baseline, 3 months, 6 months, 9 months