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

NCT ID: NCT06841276

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-02-28

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 whose main objective is to evaluate the effectiveness of the QoLibri Digital Therapy on Quality of Life improvement in patients living with chronic pain.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

QoLibri Digital Therapy

Use of the QoLibri Digital Therapy on patient smartphone (on top of Treatment as Usual) for the 6-month experimental phase of the study

Group Type: EXPERIMENTAL

QoLibri Digital Therapy

Intervention Type: DEVICE

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.

Wait-list control

Treatment as Usual for the initial 3-month experimental phase (wait list) and then Use of the QoLibri Digital Therapy on patient smartphone for the remaining 3-month experimental phase of the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

QoLibri 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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novesia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine Elyn, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Maison de santé Nailloux / Saint-Léon

Nailloux, , France

Countries

France

Central Contacts

Alice Corteval, PharmD

Role: CONTACT

a.corteval@novesia.fr

+33 6 88 08 29 72

Géraldine Batot, PhD

Role: CONTACT

geraldine.batot@kyomed.com

Facility Contacts

Sandra Coste, MD

Role: primary

sandracoste87@gmail.com

+33 5 61 81 31 25

Other Identifiers

KM00481

Identifier Type: -

Identifier Source: org_study_id