Therapeutic Education Program in Psoriasis

Psoriasis Clinical Trial

— EDUPSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310204
• Other study ID #: 10 141 01
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: June 2014

Study information

• Verified date: January 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Behavioral:
• multidisciplinary education program
both individual and group education sessions over a 6-month period in addition to standard psoriasis care

Other:
• standard psoriasis care alone

Locations

Country	Name	City	State
France	University Hospital	Brest
France	Edouard Herriot	Lyon
France	Unversity Hospital	Lyon
France	Saint Joseph Hospital	Marseille
France	Timone Hospital	Marseille
France	University Hospital	Nantes
France	Archet Hospital	Nice
France	Saint-Louis Hospital	Paris
France	Haut Leveque Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (2)

Jendoubi F, Balica S, Richard MA, Chiaverini C, Bernier C, Quiles N, Bachelez H, Beylot-Barry M, Mallet S, Goujon C, Parier J, Misery L, Carrere F, Lauwers-Cances V, Paul C; French Psoriasis Research Group. A Multicentre Randomised Controlled Study Evalua — View Citation

Viguier M, Livideanu C, Beylot-Barry M, Richard MA, Paul C, Bachelez H, Aubin F; Groupe de Recherche sur le Psoriasis. Observational case series on a group of psoriasis patients who failed to respond to any TNF blockers. J Dermatolog Treat. 2014 Feb;25(1):75-7. doi: 10.3109/09546634.2013.806766. Epub 2013 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skindex quality of life	evaluation of quality of life	3 months
Secondary	SF36 - Short Form 36		3 MONTHS
Secondary	PASI - Psoriasis Area and Severity Index		3 MONTHS