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Therapeutic Education Program in Psoriasis (EDUPSO)

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ClinicalTrials.gov Identifier: NCT02310204
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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
Psoriasis Behavioral: multidisciplinary education program Other: standard psoriasis care alone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Therapeutic Education Program in Patients With Moderate to Severe Psoriasis : a Multicenter Randomized Controlled Study
Study Start Date : May 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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



Primary Outcome Measures :
  1. skindex quality of life [ Time Frame: 3 months ]
    evaluation of quality of life


Secondary Outcome Measures :
  1. SF36 - Short Form 36 [ Time Frame: 3 MONTHS ]
  2. PASI - Psoriasis Area and Severity Index [ Time Frame: 3 MONTHS ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310204


Locations
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France
University Hospital
Brest, France, 29609
Edouard Herriot
Lyon, France, 69437
Unversity Hospital
Lyon, France, 69437
Timone Hospital
Marseille, France, 13000
Saint Joseph Hospital
Marseille, France, 13008
University Hospital
Nantes, France, 44093
Archet Hospital
Nice, France, 6000
Saint-Louis Hospital
Paris, France, 75475
Haut Leveque Hospital
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Carle PAUL, MD University Hospital, Toulouse

Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02310204     History of Changes
Other Study ID Numbers: 10 141 01
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases