Therapeutic Education Program in Psoriasis

Study Overview
=================
Brief Summary
-----------------
The primary objective of this research protocol is to assess the effect of a structured therapeutic education program on the quality of life of patients with moderate to severe psoriasis

Detailed Description
-----------------
Psoriasis is a chronic inflammatory skin disease affecting 1 to 3% of the French population. Moderate to severe psoriasis has a significant impact on quality of life. Psoriasis is associated with an increased risk of depression, social isolation, unemployment. In addition, it has recently be shown that patients with moderate to severe psoriasis have an increased incidence of cardiovascular risk factors such as hypertension, overweight, hyperlipidemia and exposure to tobacco and alcohol. These so-called comorbidites may have a negative impact on psoriasis management. They also may account for the reduced life expectancy reported in patients with severe psoriasis. Therapeutic education is a structured process whose objective is to help patients to acquire or to maintain competencies that are required to live with a chronic disease. Therapeutic education is an important process to be integrated into the therapeutic strategy. It has to take into account co-morbidities, social and psychological context and its priorities need to be defined with the patient.

Official Title
-----------------
Evaluation of a Therapeutic Education Program in Patients With Moderate to Severe Psoriasis : a Multicenter Randomized Controlled Study

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Behavioral: multidisciplinary education program
* Other: standard psoriasis care alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe psoriasis defined as patients receiving a systemic psoriasis treatment including methotrexate, cyclosporine, PUVA, retinoids or a biological agent and with significant impact on quality of life defined as a Skindex > 18 Patients with palmo-plantar or erythrodermic psoriasis may be included if they can be classified as moderate to severe according the above described definitions Exclusion Criteria: Patients not able to give informed consent, Patients not able to follow the program, Patients without social security affiliation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multidisciplinary education program<br>individual and group education sessions over a 6-month period | Behavioral: multidisciplinary education program<br>* both individual and group education sessions over a 6-month period in addition to standard psoriasis care<br>|
| Active Comparator: Standard psoriasis care alone<br>Standard psoriasis care alone | Other: standard psoriasis care alone<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skindex quality of life | evaluation of quality of life | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF36 - Short Form 36 |  | 3 MONTHS | 
| PASI - Psoriasis Area and Severity Index |  | 3 MONTHS |