NCT02310204

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

3.1 years

First QC Date

December 1, 2014

Last Update Submit

January 18, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • skindex quality of life

    evaluation of quality of life

    3 months

Secondary Outcomes (2)

  • SF36 - Short Form 36

    3 MONTHS

  • PASI - Psoriasis Area and Severity Index

    3 MONTHS

Study Arms (2)

multidisciplinary education program

EXPERIMENTAL

individual and group education sessions over a 6-month period

Behavioral: multidisciplinary education program

Standard psoriasis care alone

ACTIVE COMPARATOR

Standard psoriasis care alone

Other: standard psoriasis care alone

Interventions

multidisciplinary education programBEHAVIORAL

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

multidisciplinary education program
standard psoriasis care aloneOTHER
Standard psoriasis care alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients not able to give informed consent,
  • Patients not able to follow the program,
  • Patients without social security affiliation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University Hospital

Brest, 29609, France

Location

Edouard Herriot

Lyon, 69437, France

Location

Unversity Hospital

Lyon, 69437, France

Location

Timone Hospital

Marseille, 13000, France

Location

Saint Joseph Hospital

Marseille, 13008, France

Location

University Hospital

Nantes, 44093, France

Location

Archet Hospital

Nice, 6000, France

Location

Saint-Louis Hospital

Paris, 75475, France

Location

Haut Leveque Hospital

Pessac, 33604, France

Location

Related Publications (2)

  • 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.

    PMID: 23724854BACKGROUND

  • 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.

    PMID: 34883480RESULT

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carle PAUL, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 8, 2014

Study Start

May 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 2, 2022

Record last verified: 2022-01

Locations

FR(9)