Haut-Tief Patient Education on Psoriasis and Eczema

Sponsor

University of Zurich (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02205593

Collaborator

(none)

Enrollment

Location

Arms

125

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Atopic Dermatitis/ Eczema	Behavioral: Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 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
change in EQ VAS (EQ visual analogue scale) score [ ] [baseline, 3 months, 6 months, 9 months]
Questionnaire measuring Health related quality of life

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.