Therapeutic Education Program in Psoriasis (EDUPSO)
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
multidisciplinary education program
standard psoriasis care alone
Sponsored by
About this trial
This is an interventional supportive care trial for Psoriasis
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.
Sites / Locations
- University Hospital
- Edouard Herriot
- Unversity Hospital
- Timone Hospital
- Saint Joseph Hospital
- University Hospital
- Archet Hospital
- Saint-Louis Hospital
- Haut Leveque Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
multidisciplinary education program
Standard psoriasis care alone
Arm Description
individual and group education sessions over a 6-month period
Standard psoriasis care alone
Outcomes
Primary Outcome Measures
skindex quality of life
evaluation of quality of life
Secondary Outcome Measures
SF36 - Short Form 36
PASI - Psoriasis Area and Severity Index
Full Information
NCT ID
NCT02310204
First Posted
December 1, 2014
Last Updated
January 18, 2022
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02310204
Brief Title
Therapeutic Education Program in Psoriasis
Acronym
EDUPSO
Official Title
Evaluation of a Therapeutic Education Program in Patients With Moderate to Severe Psoriasis : a Multicenter Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
multidisciplinary education program
Arm Type
Experimental
Arm Description
individual and group education sessions over a 6-month period
Arm Title
Standard psoriasis care alone
Arm Type
Active Comparator
Arm Description
Standard psoriasis care alone
Intervention Type
Behavioral
Intervention Name(s)
multidisciplinary education program
Intervention Description
both individual and group education sessions over a 6-month period in addition to standard psoriasis care
Intervention Type
Other
Intervention Name(s)
standard psoriasis care alone
Primary Outcome Measure Information:
Title
skindex quality of life
Description
evaluation of quality of life
Time Frame
3 months
Secondary Outcome Measure Information:
Title
SF36 - Short Form 36
Time Frame
3 MONTHS
Title
PASI - Psoriasis Area and Severity Index
Time Frame
3 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carle PAUL, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Unversity Hospital
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Timone Hospital
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Saint Joseph Hospital
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Archet Hospital
City
Nice
ZIP/Postal Code
6000
Country
France
Facility Name
Saint-Louis Hospital
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Haut Leveque Hospital
City
Pessac
ZIP/Postal Code
33604
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23724854
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.
Results Reference
background
PubMed Identifier
34883480
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.
Results Reference
result
Learn more about this trial
Therapeutic Education Program in Psoriasis
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