Chronic PainQoLiDocNCT06841276
Impact of QoLibri Medical Device on the Consequences of Chronic Pain: a Randomized Controlled Trial
A study testing QoLibri Digital Therapy in people with Chronic Pain, run by Novesia at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- QoLibri Digital Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Géraldine Batot, PhD contact
France1 site, 1 recruiting
- Recruiting
Maison de santé Nailloux / Saint-Léon
Nailloux, 31560
Sandra Coste, MD, +33 5 61 81 31 25, sandracoste87@gmail.com
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Being tested
- QoLibri Digital Therapy
- Keywords
- pain, quality of life, functional impact, psychological impact, digital therapy
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: month 3
Secondary outcomes (8)
Reduction of pain repercussions
Reduction of pain repercussions measured through the Pain Impact Score (PIS)
Measured: day 0, month 3, month 6
Impact on Psychological Health
Improvement in Mental Quality of Life measured by the MHS score
Measured: day 0, month 3, month 6
Impact on Physical Health
Improvement in Physical Quality of Life measured by the PHS score
Measured: day 0, month 3, month 6
Overall Quality of Life
Improvement in overall Quality of Life measured by the PROMIS-29 domain scores
Measured: 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
Measured: month 3, month 6
Organizational impact
Evaluation of care organization measured by an in-house questionnaire
Measured: day 0, 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
Measured: month 3, month 6
Evaluation of the perceived severity of pain
Perceived severity of the pain measured by the Categorical Pain Scale
Measured: day 0, month 3, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start28 Feb 2025
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antoine Elyn, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841276
- Sponsor's protocol ID
- KM00481
- Acronym
- QoLiDoc
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the QoLibri Digital Therapy on Primary Care Patients With Chronic Pain: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06841276
- Acronym / sponsor ID
- QoLiDoc / KM00481
- Conditions
- Chronic Pain
- Keywords
- pain, quality of life, functional impact, psychological impact, digital therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- NovesiaIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QoLibri Digital Therapy | Experimental | Device: QoLibri Digital TherapyUse of the QoLibri Digital Therapy on patient smartphone (on top of Treatment as Usual) for the 6-month experimental phase of the study |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QoLibri Digital TherapyA personalized program intended for chronic pain patients. It includes digitalized physical and psychological complementary approaches dedicated to symptoms management and quality of life improvement. | Device | QoLibri Digital Therapy |
Primary outcome
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).
8 secondary outcomes
Reduction of pain repercussions
Time frame: day 0, month 3, month 6
Impact on Psychological Health
Time frame: day 0, month 3, month 6
Impact on Physical Health
Time frame: day 0, month 3, month 6
Overall Quality of Life
Time frame: day 0, month 3, month 6
Global Impression of Change
Time frame: month 3, month 6
Organizational impact
Time frame: day 0, month 3, month 6
Evaluation of the perceived user experience
Time frame: month 3, month 6
Evaluation of the perceived severity of pain
Time frame: day 0, month 3, month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Géraldine Batot, PhD contact
Antoine Elyn, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QoLibri Digital Therapy in people with Chronic Pain, run by Novesia at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Corteval, PharmD (+33 6 88 08 29 72, a.corteval@novesia.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of QoLibri Digital Therapy (time frame: month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.