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Completed

NCT Number: NCT02310204

Therapeutic Education Program in Psoriasis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

multidisciplinary education program

Behavioral

both individual and group education sessions over a 6-month period in addition to standard psoriasis care

standard psoriasis care alone

Other

Primary outcomes

  1. skindex quality of life

    Time frame: 3 months

    evaluation of quality of life

Secondary outcomes

  1. SF36 - Short Form 36

    Time frame: 3 MONTHS

  2. PASI - Psoriasis Area and Severity Index

    Time frame: 3 MONTHS

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: EDUPSO

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 8, 2014
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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