Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06841276

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

QoLibri Digital Therapy

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.

Primary outcomes

  1. Effectiveness of QoLibri Digital Therapy

    Time frame: month 3

    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).

Secondary outcomes

  1. Reduction of pain repercussions

    Time frame: day 0, month 3, month 6

    Reduction of pain repercussions measured through the Pain Impact Score (PIS)

  2. Impact on Psychological Health

    Time frame: day 0, month 3, month 6

    Improvement in Mental Quality of Life measured by the MHS score

  3. Impact on Physical Health

    Time frame: day 0, month 3, month 6

    Improvement in Physical Quality of Life measured by the PHS score

  4. Overall Quality of Life

    Time frame: day 0, month 3, month 6

    Improvement in overall Quality of Life measured by the PROMIS-29 domain scores

  5. Global Impression of Change

    Time frame: month 3, month 6

    Evaluation of patient and clinician global impression of change measured by P-GIC and C-GIC

  6. Organizational impact

    Time frame: day 0, month 3, month 6

    Evaluation of care organization measured by an in-house questionnaire

  7. Evaluation of the perceived user experience

    Time frame: month 3, month 6

    Perceived user experience of the patient and the clinician measured by an in-house questionnaire

  8. Evaluation of the perceived severity of pain

    Time frame: day 0, month 3, month 6

    Perceived severity of the pain measured by the Categorical Pain Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Corteval, PharmD

CONTACT

[email protected]

+33 6 88 08 29 72

Géraldine Batot, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Novesia

Industry

Registry information

Official study title

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

Acronym: QoLiDoc

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.