Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment
NCT ID: NCT03360864
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
110 participants
INTERVENTIONAL
2020-01-16
2023-01-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP.
Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Therapeutic Education Program
Patient randomized in this arm will attend a 1 day long validated Therapeutic Education Program.
This program will take place within 6 months after biologic treatment initiation.
Education program
Patient will participate to a education program.
No therapeutic Education Program
Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Education program
Patient will participate to a education program.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Anti-TNFalpha biological treatment initiation required
* Adult patient (age\>18years)
* Capacity to understand self-questionnaires and address questions
* Patient accepting to attend a therapeutic education program (TEP)
Exclusion Criteria
* Previous attendance to a TEP concerning biological or spondyloarthritis
* Contraindication to Anti-TNFalpha treatment
* Associated and unbalanced diseases
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Strasbourg, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christelle SORDET, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Strasbourg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6661
Identifier Type: -
Identifier Source: org_study_id