Back to resultsAnalysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis (OnderHUIDs)
Primary Purpose
Psoriasis, Atopic Dermatitis
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
education on skin disease conditions
Stress-reduction techniques
Lifestyle factors and psycho-education
no educational program
Sponsored by
About this trial
This is an interventional supportive care trial for Psoriasis focused on measuring Moderate and severe psoriasis and atopic dermatitis
Eligibility 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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
current therapy
current therapy with educational program
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT01077882
First Posted
February 26, 2010
Last Updated
July 4, 2012
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01077882
Brief 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
Acronym
OnderHUIDs
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 Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Atopic Dermatitis
Keywords
Moderate and severe psoriasis and atopic dermatitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
current therapy
Arm Type
Placebo Comparator
Arm Title
current therapy with educational program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
education on skin disease conditions
Intervention Description
information about several skin diseases skin function recommendation on care of skin
Intervention Type
Behavioral
Intervention Name(s)
Stress-reduction techniques
Intervention Description
Physical Training yoga mindfulness-based stress reduction
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle factors and psycho-education
Intervention Description
by dietician and psychiatrist
Intervention Type
Other
Intervention Name(s)
no educational program
Intervention Description
standard care without educational program
Primary Outcome Measure Information:
Title
Effectiveness of a novel educational program on the quality of life and the clinical outcome.
Description
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
Secondary Outcome Measure Information:
Title
Depression severity
Description
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
Title
Lifestyle
Description
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
Title
Medical consumption and cost-effectiveness evaluation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Lambert, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
website University Hospital Ghent
Learn more about this trial
Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis
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