Haut-Tief Patient Education on Psoriasis and Eczema

NCT ID: NCT02205593

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2022-12-31

Brief Summary

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'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

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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.

Conditions

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Psoriasis Atopic Dermatitis/ Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

Regular follow-up and treatment WITHOUT behavioural intervention

Haut Tief patient education

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Regular follow-up and treatment WITHOUT behavioural intervention

Interventions

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Control

Regular follow-up and treatment WITHOUT behavioural intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guenther Hofbauer, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Dept. of Dermatology

Locations

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University Hospital Zurich, Department of Dermatology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Haut-Tief

Identifier Type: -

Identifier Source: org_study_id

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