Evaluation of the Impact of the QoLibri Digital Therapy on Primary Care Patients With Chronic Pain: a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Effectiveness of QoLibri Digital Therapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
QoLibri Digital Therapy
Use of the QoLibri Digital Therapy on patient smartphone (on top of Treatment as Usual) for the 6-month experimental phase of the study
干预措施: QoLibri Digital Therapy (Device)
Wait-list control
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
结局指标
主要结局
Effectiveness of QoLibri Digital Therapy
时间窗: 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).
次要结局
- Organizational impact(day 0, month 3, month 6)
- Global Impression of Change(month 3, month 6)
- Evaluation of the perceived user experience(month 3, month 6)
- Evaluation of the perceived severity of pain(day 0, month 3, month 6)
- Reduction of pain repercussions(day 0, month 3, month 6)
- Impact on Psychological Health(day 0, month 3, month 6)
- Impact on Physical Health(day 0, month 3, month 6)
- Overall Quality of Life(day 0, month 3, month 6)