PsoriasisNCT02205593
Haut-Tief Patient Education on Psoriasis and Eczema
A study of Psoriasis and Atopic Dermatitis/ Eczema, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis, Atopic Dermatitis/ Eczema
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2012to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic psoriasis (disease for more than 3 months)
- Chronic eczema (disease for more than 3) months)
- Age ≥ 18 years
- Oral and written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Dermatology
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis, Atopic Dermatitis/ Eczema
- Being tested
- Control
- Keywords
- psoriasis, atopic dermatitis, eczema, patient education, stress reduction, quality of life
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Regular follow-up and treatment WITHOUT behavioural intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months) Receives: Behavioral: Control |
| Haut Tief patient education | Active comparator | patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months). Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in DLQI (Dermatology Life Quality Index) score [ ]
DLQI is a questionnaire measuring Health related quality of life 10 questions
Measured: baseline, 3 months, 6 months, 9 months
change in Skindex-29 score [ ]
Questionnaire measuring Health related quality of life 29 questions
Measured: baseline, 3 months, 6 months, 9 months
change in ShortForm 36 score [ ]
Questionnaire measuring Health related quality of life
Measured: baseline, 3 months, 6 months, 9 months
change in EQ 5D score [ ]
Questionnaire measuring Health related quality of life
Measured: baseline, 3 months, 6 months, 9 months
change in EQ VAS (EQ visual analogue scale) score [ ]
Questionnaire measuring Health related quality of life
Measured: baseline, 3 months, 6 months, 9 months
Secondary outcomes (3)
change in EASI (eczema area and severity index) score [ ]
clinical score for atopic dermatitis
Measured: baseline, 3 months, 6 months, 9 months
change in PASI (psoriasis area and severity index) [ ]
clinical score for psoriasis
Measured: baseline, 3 months, 6 months, 9 months
BDI (Beck Depression Inventory) score [ ]
Measured: baseline, 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJul 2012
- Primary completionOct 2018
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guenther Hofbauer, Prof MD, Principal investigator, University Hospital Zurich, Dept. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205593
- Sponsor's protocol ID
- Haut-Tief
- Status last verified
- Jul 2019
- First submitted
- 14 Jul 2014
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study of the Impact of Education and Stress-reduction Techniques on Psoriasis and Eczema.
- ClinicalTrials.gov ID
- NCT02205593
- Acronym / sponsor ID
- Haut-Tief
- Conditions
- Psoriasis, Atopic Dermatitis/ Eczema
- Keywords
- psoriasis, atopic dermatitis, eczema, patient education, stress reduction, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Controlpatient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months) |
| Haut Tief patient education | Active comparator | Behavioral: Controlpatient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic psoriasis (disease for more than 3 months)
- Chronic eczema (disease for more than 3) months)
- Age ≥ 18 years
- Oral and written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlRegular follow-up and treatment WITHOUT behavioural intervention | Behavioural | Control, Haut Tief patient education |
Primary outcome
change in DLQI (Dermatology Life Quality Index) score [ ]
Time frame: baseline, 3 months, 6 months, 9 months
DLQI is a questionnaire measuring Health related quality of life 10 questions
change in Skindex-29 score [ ]
Time frame: baseline, 3 months, 6 months, 9 months
Questionnaire measuring Health related quality of life 29 questions
change in ShortForm 36 score [ ]
Time frame: baseline, 3 months, 6 months, 9 months
Questionnaire measuring Health related quality of life
change in EQ 5D score [ ]
Time frame: baseline, 3 months, 6 months, 9 months
Questionnaire measuring Health related quality of life
change in EQ VAS (EQ visual analogue scale) score [ ]
Time frame: baseline, 3 months, 6 months, 9 months
Questionnaire measuring Health related quality of life
3 secondary outcomes
change in EASI (eczema area and severity index) score [ ]
Time frame: baseline, 3 months, 6 months, 9 months
change in PASI (psoriasis area and severity index) [ ]
Time frame: baseline, 3 months, 6 months, 9 months
BDI (Beck Depression Inventory) score [ ]
Time frame: baseline, 3 months, 6 months, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guenther Hofbauer, Prof MD principal investigator
University Hospital Zurich, Dept. of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Psoriasis and Atopic Dermatitis/ Eczema, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in DLQI (Dermatology Life Quality Index) score [ ] (time frame: baseline, 3 months, 6 months, 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.