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)
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01077882
First received: February 26, 2010
Last updated: July 4, 2012
Last verified: July 2012
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Purpose
'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.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
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:
- Depression severity [ Time Frame: At 12 weeks, 6 months and 9 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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).
| Enrollment: | 50 |
| Study Start Date: | January 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 skin
Behavioral: Stress-reduction techniques
Physical Training yoga mindfulness-based stress reduction
Behavioral: Lifestyle factors and psycho-education
by dietician and psychiatrist
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT01077882 History of Changes |
| Other Study ID Numbers: | 2009/691 |
| Study First Received: | February 26, 2010 |
| Last Updated: | July 4, 2012 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by University Hospital, Ghent:
|
Moderate and severe psoriasis and atopic dermatitis |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Psoriasis Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Skin Diseases, Papulosquamous |
ClinicalTrials.gov processed this record on May 16, 2013