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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Page 1 of 1 (1 locations)

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Maison de santé Nailloux / Saint-Léon

Nailloux, France, 31560

Impact of QoLibri Medical Device on the Consequences of Chronic Pain: a Randomized Controlled Trial | DecenTrialz