Impact of QoLibri Medical Device on the Consequences of Chronic Pain: a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QoLibri Digital Therapy.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Impact of the QoLibri Digital Therapy on Primary Care Patients With Chronic Pain: a Randomized Controlled Clinical Trial.
Overview
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.
Interventions
- 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.
Primary outcome measures
- Effectiveness of QoLibri Digital Therapy [Time frame: month 3]
Secondary outcome measures (8)
- 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]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Maison de santé Nailloux / Saint-Léon — Nailloux
Identifiers
NCT: NCT06841276 · KM00481