Clinical trial NCT02310204: Therapeutic Education Program in Psoriasis
Official title: Evaluation of a Therapeutic Education Program in Patients With Moderate to Severe Psoriasis : a Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: skindex quality of life
timeFrame: 3 months
Secondary outcomes:
measure: SF36 - Short Form 36
timeFrame: 3 MONTHS
measure: PASI - Psoriasis Area and Severity Index
timeFrame: 3 MONTHS
Other outcomes:
Locations:
city: Brest
country: France
facility: University Hospital
city: Lyon
country: France
facility: Edouard Herriot
city: Lyon
country: France
facility: Unversity Hospital
city: Marseille
country: France
facility: Timone Hospital
city: Marseille
country: France
facility: Saint Joseph Hospital
city: Nantes
country: France
facility: University Hospital
city: Nice
country: France
facility: Archet Hospital
city: Paris
country: France
facility: Saint-Louis Hospital
city: Pessac
country: France
facility: Haut Leveque Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Carle PAUL, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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 Evaluating the Effect of a Standardised Education Programme on Quality of Life, Disease Severity, and Disease Knowledge in Patients with Moderate-To-Severe Psoriasis: The EDUPSO Study. Dermatology. 2022;238(4):630-639. doi: 10.1159/000520289. Epub 2021 Dec 9.