Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis (OnderHUIDs)
|ClinicalTrials.gov Identifier: NCT01077882|
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : July 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Atopic Dermatitis||Behavioral: education on skin disease conditions Behavioral: Stress-reduction techniques Behavioral: Lifestyle factors and psycho-education Other: no educational program||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
|Placebo Comparator: current therapy||
Other: no educational program
standard care without educational program
|Experimental: current therapy with educational program||
Behavioral: education on skin disease conditions
information about several skin diseases skin function recommendation on care of skinBehavioral: Stress-reduction techniques
Physical Training yoga mindfulness-based stress reductionBehavioral: Lifestyle factors and psycho-education
by dietician and psychiatrist
- Effectiveness of a novel educational program on the quality of life and the clinical outcome. [ Time Frame: 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.
- Depression severity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077882
|University Hospital Ghent|
|Principal Investigator:||Jo Lambert, MD, PhD||University Hospital, Ghent|