Status:
RECRUITING
Impact of QoLibri Medical Device on the Consequences of Chronic Pain: a Randomized Controlled Trial
Lead Sponsor:
Novesia
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A superiority study evaluating the impact of the QoLibri Software as Medical Device on functional and psychological consequences of chronic pain in primary care patients. A prospective, cluster-random...
Eligibility Criteria
Inclusion Criteria:
- Patient experiencing at least moderate pain (on the Categorical Pain Scale) for more than 3 months
- Patient with a BPI interference score ≥ 3 in at least 3 out of 7 dimensions
- Patient with a smartphone and an internet connection at the place of use
- Patient affiliated with a social security system or benefiting from such a system
Exclusion Criteria:
- Patient opposing participation in the study
- Patient with severe anxiety and/or depressive disorders (especially a suicidal risk)
- Patient presenting one or more barriers to the initiation of cognitive-behavioral therapy (significant social difficulties, low adherence to current care, insufficient memory or cognitive abilities, lack of time, lack of motivation...),
- Adult patient under legal protection measures (guardianship, legal safeguard, psychiatric care, or deprived of liberty by judicial or administrative decision)
Key Trial Info
Start Date :
February 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT06841276
Start Date
February 28 2025
End Date
April 1 2027
Last Update
February 4 2026
Active Locations (1)
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1
Maison de santé Nailloux / Saint-Léon
Nailloux, France, 31560