A Phase 4 interventional study of education on skin disease conditions and Stress-reduction techniques in Psoriasis and Atopic Dermatitis, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-07-06.
Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Supportive care
'OnderHUIDs' is an educational program (Department of Dermatology, University Hospital, Gent) for patients with psoriasis and atopic dermatitis. We want to stimulate the patient to actively participate in their therapeutic approach by enhanced self care. We call the hypothesis that this program will help the patients learn to cope with their disease and to be loyal to their treatment, which will result in a better quality of life, better clinical outcome and cost effectiveness.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 50 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: no educational program
Behavioral: education on skin disease conditions · Behavioral: Stress-reduction techniques · Behavioral: Lifestyle factors and psycho-education
information about several skin diseases skin function recommendation on care of skin
Physical Training yoga mindfulness-based stress reduction
by dietician and psychiatrist
standard care without educational program
Effectiveness of a novel educational program on the quality of life and the clinical outcome.
Therefore quality of life questionnaires are completed at the beginning of the program, at the end of the program (12 weeks), after 6 months and after 9 months. The quality of life questionnaires are Daily life quality index, Skindex 29, EuroQol -5D, Short Form - 36 , Psoriasis disability index, Quality of Life Index for Atopic Dermatitis. The clinical effectiveness is determined by measuring psoriasis area and severity index (PASI) or scoring atopic dermatitis (SCORAD) at the beginning of the program, at the end of the program (12 weeks), after 6 months and after 9 months.
Time frame: At 12 weeks, after 6 and 9 months
Depression severity
Beck Depression Inventory (BDI) is a self-completed questionnaire with 21 questions. It is one of the most widely used instruments for measuring depression severity. BDI scores are collected during the four study visits.
Time frame: At 12 weeks, 6 months and 9 months
Lifestyle
Patients are queried for changes in smoking behaviour and physical activity monthly. Also, stress is examined during the four study visits,therefore we use the Everyday Problem Checklist.
Time frame: At 12 weeks, 6 months and 9 months
Medical consumption and cost-effectiveness evaluation
Medical therapy of patients is divided into: topical therapy, systemic therapy, combination of topical and systemic therapy or no therapy. Patients are asked for changes in medical therapy monthly. Also, medical consumption is followed: costs for medication and doctor visits related to the management of the skin disease. EuroQol-5D (EQ-5D) questionnaires are used as standardised instrument to measure health outcomes. For cost-utility analysis, gain in quality-adjusted life years utilities is plotted against time, using the area under the curve approach (cost in EUR/EQ-5D gain).
Time frame: At 12 weeks, 6 months and 9 months
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent