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Clinical Trials/NCT02310204
NCT02310204
Completed
N/A

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

University Hospital, Toulouse8 sites in 1 country187 target enrollmentMay 2011
ConditionsPsoriasis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psoriasis
Sponsor
University Hospital, Toulouse
Enrollment
187
Locations
8
Primary Endpoint
skindex quality of life
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
June 2014
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

skindex quality of life

Time Frame: 3 months

evaluation of quality of life

Secondary Outcomes

  • SF36 - Short Form 36(3 MONTHS)
  • PASI - Psoriasis Area and Severity Index(3 MONTHS)

Study Sites (8)

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