Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis
- Conditions
- Atopic DermatitisPsoriasis
- Interventions
- Other: no educational programBehavioral: education on skin disease conditionsBehavioral: Stress-reduction techniquesBehavioral: Lifestyle factors and psycho-education
- Registration Number
- NCT01077882
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
'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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Patients who have given written informed consent
- Women or men of any race
- Patients who are 18-75 years of age
- Diagnosis of psoriasis or atopic dermatitis
- Patients with a cognitive disorder (not able to understand, speak, read or write..)
- Patients with a significant underlying medical cause (i.e. severe infection, haematologic disease, malignity, severe renal or hepatic disease, major depression) in the last 3 months
- Patients under experimental pharmaceutical medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description current therapy no educational program - current therapy with educational program Lifestyle factors and psycho-education - current therapy with educational program Stress-reduction techniques - current therapy with educational program education on skin disease conditions -
- Primary Outcome Measures
Name Time Method Effectiveness of a novel educational program on the quality of life and the clinical outcome. At 12 weeks, after 6 and 9 months 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.
- Secondary Outcome Measures
Name Time Method Depression severity At 12 weeks, 6 months and 9 months 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.
Lifestyle At 12 weeks, 6 months and 9 months 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.
Medical consumption and cost-effectiveness evaluation At 12 weeks, 6 months and 9 months 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).
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium