Chronic Pain
Conditions
Keywords
pain, quality of life, functional impact, psychological impact, digital therapy
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.
Interventions
DEVICEQoLibri 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.
Sponsors
Novesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of QoLibri Digital Therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Reduction of pain repercussions | day 0, month 3, month 6 | Reduction of pain repercussions measured through the Pain Impact Score (PIS) |
| Impact on Psychological Health | day 0, month 3, month 6 | Improvement in Mental Quality of Life measured by the MHS score |
| Impact on Physical Health | day 0, month 3, month 6 | Improvement in Physical Quality of Life measured by the PHS score |
| Overall Quality of Life | day 0, month 3, month 6 | Improvement in overall Quality of Life measured by the PROMIS-29 domain scores |
| Global Impression of Change | month 3, month 6 | Evaluation of patient and clinician global impression of change measured by P-GIC and C-GIC |
| Organizational impact | day 0, month 3, month 6 | Evaluation of care organization measured by an in-house questionnaire |
| Evaluation of the perceived user experience | month 3, month 6 | Perceived user experience of the patient and the clinician measured by an in-house questionnaire |
| Evaluation of the perceived severity of pain | day 0, month 3, month 6 | Perceived severity of the pain measured by the Categorical Pain Scale |
Countries
France
Contacts
CONTACTAlice Corteval, PharmD
CONTACTGéraldine Batot, PhD
PRINCIPAL_INVESTIGATORAntoine Elyn, MD
Outcome results
None listed