RecruitingNot ApplicableNCT06841276

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

Evaluation of the Impact of the QoLibri Digital Therapy on Primary Care Patients With Chronic Pain: a Randomized Controlled Clinical Trial.

Sponsor

Novesia

Enrollment

410 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Pain

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEQoLibri Digital Therapy

A personalized program intended for chronic pain patients. It includes digitalized physical and psychological complementary approaches dedicated to symptoms management and quality of life improvement.