Skip to main content
Clinical Trials/NCT04880096
NCT04880096
Recruiting
Not Applicable

Constitution and Analysis of a Cohort of Patients Followed in Pain Clinics and at Home in Real Life

University Hospital, Clermont-Ferrand22 sites in 1 country5,000 target enrollmentSeptember 14, 2021
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
5000
Locations
22
Primary Endpoint
multidimensional characterisation of chronic pain patients
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness and important adverse effects. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care.

In order to allow the characterization and a personalized follow-up of chronic pain patients, we have created e-DOL, a smartphone application for patients and a web platform for healthcare professionals in pain clinics. The purpose of this study is to create an e-cohort for the research, and characterization and follow-up of chronic pain patients.

Detailed Description

This first French e-cohort of chronic pain patients will allow real-life follow-up in order to generate big data including various information on chronic pain, associated-comorbidities, pain impacts on sleep, activity and psycho-emotional parameters, sociodemographic characteristics and pain treatments. These data will be collected with he eDOL tool (smartphone application for patients and web platform for caregivers in pain clinics), integrating numerous repeatable questionnaires, weekly barometers, a therapeutic education module and a conversational agent (chat bot). All of these data will also be linked with French health insurance care data in order to get an overview of comorbidities and patient care consumption in a medico-economic approach. The study will include 20 pain clinics and a minimum of 5000 patients followed for 24 months.

Registry
clinicaltrials.gov
Start Date
September 14, 2021
End Date
September 1, 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All patients with chronic pain
  • patients equipped and regular users of a smartphone
  • Non-opposition to participation in the study

Exclusion Criteria

  • Patient unable to understand or answer questionnaires

Outcomes

Primary Outcomes

multidimensional characterisation of chronic pain patients

Time Frame: 5 years

Multimodal exploratory analysis of the determinants and repercussions of chronic pain, and their evolution in a real-life context, taking into account all environmental events likely to influence chronic pain (treatments, history, co-morbidities, etc.).

Secondary Outcomes

  • Multivariate descriptive analyses(5 years)
  • Longitudinal analyses(5 years)

Study Sites (22)

Loading locations...

Similar Trials