NCT06841276

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
11mo left

Started Feb 2025

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Feb 2025Apr 2027

First Submitted

Initial submission to the registry

February 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 18, 2025

Last Update Submit

February 2, 2026

Conditions

Chronic Pain

Keywords

pain, quality of life, functional impact, psychological impact, digital therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Reduction of pain repercussions

    day 0, month 3, month 6

  • Impact on Psychological Health

    day 0, month 3, month 6

  • Impact on Physical Health

    day 0, month 3, month 6

  • Overall Quality of Life

    day 0, month 3, month 6

  • Global Impression of Change

    month 3, month 6

  • +3 more secondary outcomes

Study Arms (2)

QoLibri Digital Therapy

EXPERIMENTAL

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

Wait-list control

NO INTERVENTION

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

Interventions

QoLibri Digital TherapyDEVICE

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.

QoLibri Digital Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison de santé Nailloux / Saint-Léon

Nailloux, 31560, France

RECRUITING

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antoine Elyn, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Corteval, PharmD

CONTACT

+33 6 88 08 29 72a.corteval@novesia.fr

Géraldine Batot, PhD

CONTACT

geraldine.batot@kyomed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 24, 2025

Study Start

February 28, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

FR(1)