NCT06841276 Impact of QoLibri Medical Device on the Consequences of Chronic Pain: a Randomized Controlled Trial
| NCT ID | NCT06841276 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novesia |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2025-02-28 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 410 participants in total. It began in 2025-02-28 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-randomized, wait list, controlled multicentre study with the main objective of evaluating the effectiveness of the QoLibri Digital Therapy on Quality of Life improvement in patients living with chronic pain.
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)
Contact & Investigator
Antoine Elyn, MD
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT06841276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06841276 currently recruiting?
Yes, NCT06841276 is actively recruiting participants. Contact the research team at a.corteval@novesia.fr for enrollment information.
Where is the NCT06841276 trial being conducted?
This trial is being conducted at Nailloux, France.
Who is sponsoring the NCT06841276 clinical trial?
NCT06841276 is sponsored by Novesia. The principal investigator is Antoine Elyn, MD. The trial plans to enroll 410 participants.
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