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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Device: QoLibri Digital Therapy

• Study Type: Interventional
• Enrollment (Estimated): 410
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice Corteval, PharmD; Phone Number: +33 6 88 08 29 72; Email: a.corteval@novesia.fr
• Study Contact Backup: Name: Géraldine Batot, PhD; Email: geraldine.batot@kyomed.com

Study Locations

• France
  • Nailloux, France, 31560
    • Recruiting
    • Maison de santé Nailloux / Saint-Léon
    • Contact: Sandra Coste, MD; Phone Number: +33 5 61 81 31 25; Email: sandracoste87@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of QoLibri Digital Therapy	Pain repercussions measured through the Pain Impact Score (PIS) which combines scores from 3 different domains evaluated by the PROMIS-29 (pain intensity, physical function, and pain interference) and quantifies the extent to which pain interferes with function and daily activities).	month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organizational impact	Evaluation of care organization measured by an in-house questionnaire	day 0, month 3, month 6
Global Impression of Change	Evaluation of patient and clinician global impression of change measured by P-GIC and C-GIC	month 3, month 6
Evaluation of the perceived user experience	Perceived user experience of the patient and the clinician measured by an in-house questionnaire	month 3, month 6
Evaluation of the perceived severity of pain	Perceived severity of the pain measured by the Categorical Pain Scale	day 0, month 3, month 6
Reduction of pain repercussions	Reduction of pain repercussions measured through the Pain Impact Score (PIS)	day 0, month 3, month 6
Impact on Psychological Health	Improvement in Mental Quality of Life measured by the MHS score	day 0, month 3, month 6
Impact on Physical Health	Improvement in Physical Quality of Life measured by the PHS score	day 0, month 3, month 6
Overall Quality of Life	Improvement in overall Quality of Life measured by the PROMIS-29 domain scores	day 0, month 3, month 6

Collaborators and Investigators

• Sponsor: Novesia
• Investigators: Principal Investigator: Antoine Elyn, MD

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pain, quality of life, functional impact, psychological impact, digital therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain
• Other Study ID Numbers: KM00481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No