PsoriasisEDUPSONCT02310204
Therapeutic Education Program in Psoriasis
A study testing multidisciplinary education program and standard psoriasis care alone in people with Psoriasis, run by University Hospital, Toulouse at 9 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- multidisciplinary education program and standard psoriasis care alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 9 sitesFrance
- Study dates
- May 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients not able to give informed consent,
- Patients not able to follow the program,
- Patients without social security affiliation.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
University Hospital
Brest, 29609
Edouard Herriot
Lyon, 69437
Unversity Hospital
Lyon, 69437
Timone Hospital
Marseille, 13000
Saint Joseph Hospital
Marseille, 13008
University Hospital
Nantes, 44093
Archet Hospital
Nice, 6000
Saint-Louis Hospital
Paris, 75475
Haut Leveque Hospital
Pessac, 33604
About this study
Official title: Evaluation of a Therapeutic Education Program in Patients With Moderate to Severe Psoriasis : a Multicenter Randomized Controlled Study
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
Read the 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.
- Conditions
- Psoriasis
- Being tested
- multidisciplinary education program, standard psoriasis care alone
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary education programBehavioural
both individual and group education sessions over a 6-month period in addition to standard psoriasis care
standard psoriasis care aloneOther
| Study group | Role | What they receive |
|---|---|---|
| multidisciplinary education program | Experimental | individual and group education sessions over a 6-month period Receives: Behavioral: multidisciplinary education program |
| Standard psoriasis care alone | Active comparator | Standard psoriasis care alone Receives: Other: standard psoriasis care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
skindex quality of life
evaluation of quality of life
Measured: 3 months
Secondary outcomes (2)
SF36 - Short Form 36
Measured: 3 MONTHS
PASI - Psoriasis Area and Severity Index
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startMay 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carle PAUL, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310204
- Sponsor's protocol ID
- 10 141 01
- Acronym
- EDUPSO
- Status last verified
- Jan 2022
- First submitted
- 1 Dec 2014
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23724854Jendoubi 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.
PubMed 34883480
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Therapeutic Education Program in Patients With Moderate to Severe Psoriasis : a Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02310204
- Acronym / sponsor ID
- EDUPSO / 10 141 01
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multidisciplinary education program | Experimental | Behavioral: multidisciplinary education programindividual and group education sessions over a 6-month period |
| Standard psoriasis care alone | Active comparator | Other: standard psoriasis care aloneStandard psoriasis care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients not able to give informed consent,
- Patients not able to follow the program,
- Patients without social security affiliation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary education programboth individual and group education sessions over a 6-month period in addition to standard psoriasis care | Behavioural | multidisciplinary education program |
| standard psoriasis care alone | Other | Standard psoriasis care alone |
Primary outcome
skindex quality of life
Time frame: 3 months
evaluation of quality of life
2 secondary outcomes
SF36 - Short Form 36
Time frame: 3 MONTHS
PASI - Psoriasis Area and Severity Index
Time frame: 3 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Background: PubMed 23724854Viguier 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 publication: PubMed 34883480Jendoubi 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.
Related trials for Psoriasis
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carle PAUL, MD principal investigator
University Hospital, Toulouse
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary education program and standard psoriasis care alone in people with Psoriasis, run by University Hospital, Toulouse at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skindex quality of life (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310204, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022; AzTrials last refreshed its copy on 1 Nov 2026.