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

Novesia

Status: Enrolling

Conditions: Chronic Pain

Treatments: Device: QoLibri Digital Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06841276

KM00481

Details and patient eligibility

About

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.

Enrollment: 410 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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410 participants in 2 patient groups

QoLibri Digital Therapy

Experimental group

Description:

Use of the QoLibri Digital Therapy on patient smartphone (on top of Treatment as Usual) for the 6-month experimental phase of the study

Treatment:

Device: QoLibri Digital Therapy

Wait-list control

No Intervention group

Description:

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