Evaluating the Effectiveness of QoLibri Digital Therapy on Quality of Life for Adults with Chronic Pain in Primary Care

What this Trial Is About

Researchers are evaluating the impact of the QoLibri Software as a Medical Device on people living with chronic pain in primary care settings. This study is designed as a prospective, cluster-randomized, wait-list controlled multicenter trial to assess how the QoLibri Digital Therapy affects the quality of life, functional abilities, and psychological health of patients with chronic pain. The main goal is to determine if this digital therapy can improve patients overall well-being compared to usual care. Participants are randomly assigned to one of two groups. One group uses the QoLibri Digital Therapy on their smartphone for a six-month experimental phase alongside their usual treatment. The other group starts with treatment as usual for three months wait-list control and then uses the QoLibri therapy on their smartphone for the remaining three months. The therapy includes personalized digital physical and psychological support aimed at managing symptoms and enhancing quality of life. Throughout the study, participants will be monitored at multiple time points day 0, month 3, and month 6 to evaluate changes in pain impact, psychological and physical health, overall quality of life, and user experience with the device. Researchers will also assess organizational impact and patients global impression of change. The primary outcome focuses on the effectiveness of the QoLibri therapy at month 3. The total study participation spans six months with ongoing assessments to track safety and treatment effects.

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