Health-Related Quality of Life Assessment And Communication During 48 Weeks of Treatment of Moderate to Severe Psoriasis.
Recruiting
- Conditions
- Keywords:Psoriasis, Health-Related Quality of Life, Etanercept.doctor-patient communication, psoriasis patients
- Registration Number
- NL-OMON24504
- Lead Sponsor
- Stichting AquamarijnMeibergdreef 91105 AZ AMSTERDAM ZO
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Eighteen years of age or older at time of consent.
2. Established diagnosis of plaque psoriasis.
Exclusion Criteria
1. Patients of childbearing potential who are not using or willing to use adequate anti-conceptive measures.
2. Contraindications for the use of etanercept: sepsis or risk of sepsis, including local infections.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoints: <br /><br /><br><br>1. Communication (COM):<br /><br>Communication Questionnaire (COM), a study-specific two-dimensional questionnaire concerning<br /><br> a) the quantity of HRQL-communication during consultations<br /><br>b) the satisfaction with doctor ¨C patient communication. <br><br /><br /><br>2. Overall HRQL:<br /><br>Dermatology Life Quality Index, a well-established dermatology-specific HRQL measure (DLQI).
- Secondary Outcome Measures
Name Time Method Secondary Efficacy Endpoints:<br /><br /><br><br>1. Health Status (HS)<br /><br>Medical Outcomes Study 36-item Short-Form General Health Survey, a well-established, eight-dimensional, generic health status measure (SF-36). <br><br /><br /><br>2. Global Disease Severity (GDS)<br /><br>a. Psoriasis Area and Severity Index (PASI)<br /><br>b. Physician Global Assessment & Patient Global Assessment.<br><br /><br /><br>3. Overall Evaluation (OE)<br /><br>A study-specific questionnaire concerning <br /><br>a) satisfaction with the treatment process, including doctor ¨C patient communication<br /><br>b) satisfaction with treatment outcomes<br /><br>c) the feasibility of HRQL-assessment and HRQL- communication in dermatological practice at large.