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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of pain repercussions | Reduction of pain repercussions measured through the Pain Impact Score (PIS) | day 0, month 3, month 6 |
| Impact on Psychological Health | Improvement in Mental Quality of Life measured by the MHS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice Corteval, PharmD | Contact | +33 6 88 08 29 72 | a.corteval@novesia.fr | |
| Géraldine Batot, PhD | Contact | geraldine.batot@kyomed.com |
| Name | Affiliation | Role |
|---|---|---|
| Antoine Elyn, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maison de santé Nailloux / Saint-Léon | Recruiting | Nailloux | 31560 | France |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| day 0, month 3, month 6 |
| Impact on Physical Health | Improvement in Physical Quality of Life measured by the PHS score | day 0, month 3, month 6 |
| Overall Quality of Life | Improvement in overall Quality of Life measured by the PROMIS-29 domain scores | 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 | month 3, month 6 |
| Organizational impact | Evaluation of care organization measured by an in-house questionnaire | 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 | month 3, month 6 |
| Evaluation of the perceived severity of pain | Perceived severity of the pain measured by the Categorical Pain Scale | day 0, month 3, month 6 |