Therapeutic Education Program in Psoriasis

NCT ID: NCT02310204

Last Updated: 2022-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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multidisciplinary education program

individual and group education sessions over a 6-month period

Group Type EXPERIMENTAL

multidisciplinary education program

Intervention Type BEHAVIORAL

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

Standard psoriasis care alone

Standard psoriasis care alone

Group Type ACTIVE_COMPARATOR

standard psoriasis care alone

Intervention Type OTHER

Interventions

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multidisciplinary education program

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

Intervention Type BEHAVIORAL

standard psoriasis care alone

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carle PAUL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital

Brest, , France

Site Status

Edouard Herriot

Lyon, , France

Site Status

Unversity Hospital

Lyon, , France

Site Status

Timone Hospital

Marseille, , France

Site Status

Saint Joseph Hospital

Marseille, , France

Site Status

University Hospital

Nantes, , France

Site Status

Archet Hospital

Nice, , France

Site Status

Saint-Louis Hospital

Paris, , France

Site Status

Haut Leveque Hospital

Pessac, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 23724854 (View on PubMed)

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.

Reference Type RESULT
PMID: 34883480 (View on PubMed)

Other Identifiers

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10 141 01

Identifier Type: -

Identifier Source: org_study_id

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