EDUPSO: Therapeutic Education Program in Psoriasis
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: multidisciplinary education program individual and group education sessions over a 6-month period |
Behavioral: multidisciplinary education program
both individual and group education sessions over a 6-month period in addition to standard psoriasis care
|
| Active Comparator: Standard psoriasis care alone Standard psoriasis care alone |
Other: standard psoriasis care alone
|
Outcome Measures
Primary Outcome Measures
- skindex quality of life [3 months]
evaluation of quality of life
Secondary Outcome Measures
- SF36 - Short Form 36 [3 MONTHS]
- PASI - Psoriasis Area and Severity Index [3 MONTHS]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital | Brest | France | 29609 | |
| 2 | Edouard Herriot | Lyon | France | 69437 | |
| 3 | Unversity Hospital | Lyon | France | 69437 | |
| 4 | Timone Hospital | Marseille | France | 13000 | |
| 5 | Saint Joseph Hospital | Marseille | France | 13008 | |
| 6 | University Hospital | Nantes | France | 44093 | |
| 7 | Archet Hospital | Nice | France | 6000 | |
| 8 | Saint-Louis Hospital | Paris | France | 75475 | |
| 9 | Haut Leveque Hospital | Pessac | France | 33604 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Carle PAUL, MD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
- 10 141 01