Therapeutic Education Program in Psoriasis

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Other: standard psoriasis care alone; Behavioral: multidisciplinary education program

• Registration Number: NCT02310204
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard psoriasis care alone	standard psoriasis care alone	Standard psoriasis care alone
multidisciplinary education program	multidisciplinary education program	individual and group education sessions over a 6-month period

Primary Outcome Measures

Name	Time	Method
skindex quality of life	3 months	evaluation of quality of life

Secondary Outcome Measures

Name	Time	Method
SF36 - Short Form 36	3 MONTHS
PASI - Psoriasis Area and Severity Index	3 MONTHS

Trial Locations

Locations (8)

Edouard Herriot; 🇫🇷 Lyon, France

Saint-Louis Hospital; 🇫🇷 Paris, France

Unversity Hospital; 🇫🇷 Lyon, France

Archet Hospital; 🇫🇷 Nice, France

University Hospital; 🇫🇷 Nantes, France

Timone Hospital; 🇫🇷 Marseille, France

Saint Joseph Hospital; 🇫🇷 Marseille, France

Haut Leveque Hospital; 🇫🇷 Pessac, France