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Recruiting NCT04880096

Cohort of Chronic Pain Patients

— Observational Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eDOL.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other eDOL
    e-health tool (mobile app for patients and web platform for caregivers in pain clinics)

Primary outcome measures

  • multidimensional characterisation of chronic pain patients [Time frame: 5 years]
Secondary outcome measures (2)
  • Multivariate descriptive analyses [Time frame: 5 years]
  • Longitudinal analyses [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 22 centers
  • CHU de Clermont-Ferrand - Service de Neurologie — Clermont-Ferrand
  • Clermont-Ferrand University Hospital — Clermont-Ferrand
  • APHP Ambroise Paré — Boulogne-Billancourt
  • APHP Saint Antoine — Paris
  • APHP Cochin — Paris
  • Groupe Hospitalier Paris Saint Joseph — Paris
  • CHU Amiens — Amiens
  • CH Bayeux — Bayeux
  • … and 14 more centers

Publications

  • Delage N, Cantagrel N, Soriot-Thomas S, Frost M, Deleens R, Ginies P, Eschalier A, Corteval A, Laveyssiere A, Phalip J, Bertin C, Pereira B, Chenaf C, Doreau B, Authier N; ePAIN; Kerckhove N. Mobile Health App and Web Platform (eDOL) for Medical Follow-Up of Patients With Chronic Pain: Cohort Study Involving the French eDOL National Cohort After 1 Year. JMIR Mhealth Uhealth. 2024 Jun 12;12:e54579. PMID 38865173

Identifiers

NCT: NCT04880096 · RNI 2020 AUTHIER

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗