Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-20 @ 12:38 AM
Study NCT ID:
NCT02205593
Status:
UNKNOWN
Last Update Posted:
2019-07-26
First Post:
2014-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Haut-Tief Patient Education on Psoriasis and Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2014-07-14', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in DLQI (Dermatology Life Quality Index) score [ ]', 'timeFrame': 'baseline, 3 months, 6 months, 9 months', 'description': 'DLQI is a questionnaire measuring Health related quality of life 10 questions'}, {'measure': 'change in Skindex-29 score [ ]', 'timeFrame': 'baseline, 3 months, 6 months, 9 months', 'description': 'Questionnaire measuring Health related quality of life 29 questions'}, {'measure': 'change in ShortForm 36 score [ ]', 'timeFrame': 'baseline, 3 months, 6 months, 9 months', 'description': 'Questionnaire measuring Health related quality of life'}, {'measure': 'change in EQ 5D score [ ]', 'timeFrame': 'baseline, 3 months, 6 months, 9 months', 'description': 'Questionnaire measuring Health related quality of life'}, {'measure': 'change in EQ VAS (EQ visual analogue scale) score [ ]', 'timeFrame': 'baseline, 3 months, 6 months, 9 months', 'description': 'Questionnaire measuring Health related quality of life'}], 'secondaryOutcomes': [{'measure': 'change in EASI (eczema area and severity index) score [ ]', 'timeFrame': 'baseline, 3 months, 6 months, 9 months', 'description': 'clinical score for atopic dermatitis'}, {'measure': 'change in PASI (psoriasis area and severity index) [ ]', 'timeFrame': 'baseline, 3 months, 6 months, 9 months', 'description': 'clinical score for psoriasis'}, {'measure': 'BDI (Beck Depression Inventory) score [ ]', 'timeFrame': 'baseline, 3 months, 6 months, 9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['psoriasis', 'atopic dermatitis', 'eczema', 'patient education', 'stress reduction', 'quality of life'], 'conditions': ['Psoriasis', 'Atopic Dermatitis/ Eczema']}, 'descriptionModule': {'briefSummary': "'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.", 'detailedDescription': '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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic psoriasis (disease for more than 3 months)\n* Chronic eczema (disease for more than 3) months)\n* Age ≥ 18 years\n* Oral and written informed consent\n\nExclusion Criteria:\n\n* systemic antiinflammatory therapy\n* treatment with other investigational products\n* other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),\n* known or suspected non-compliance, drug or alcohol abuse,\n* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject\n* participation in another study within the 30 days preceding and during the present study, (viii) previous enrollment into the current study,\n* enrolment of the investigator, his/her family members, employees and other dependent persons.'}, 'identificationModule': {'nctId': 'NCT02205593', 'briefTitle': 'Haut-Tief Patient Education on Psoriasis and Eczema', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'A Prospective, Randomized, Controlled Study of the Impact of Education and Stress-reduction Techniques on Psoriasis and Eczema.', 'orgStudyIdInfo': {'id': 'Haut-Tief'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'patient group receiving regular follow-up visits (baseline, 3 months, 6 months, 9 months)', 'interventionNames': ['Behavioral: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Haut Tief patient education', 'description': 'patient group receives the educational program with regular follow-up visits (baseline, 3 months, 6 months, 9 months).', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Regular follow-up and treatment WITHOUT behavioural intervention', 'armGroupLabels': ['Control', 'Haut Tief patient education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Department of Dermatology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Guenther Hofbauer, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Dept. of Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}