Cohort of Chronic Pain Patients

Recruiting

• Conditions: Chronic Pain
• Interventions: Other: eDOL

• Registration Number: NCT04880096
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-10
• Study Start: 2021-09-14
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic pain patients	eDOL	All adult patients followed-up in participating pain clinics

Primary Outcome Measures

Name	Time	Method
multidimensional characterisation of chronic pain patients	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 Outcome Measures

Name	Time	Method
Multivariate descriptive analyses	5 years	Study the relationships between the measured criteria
Longitudinal analyses	5 years	Describe the distribution and temporal evolution of the measured variables

Trial Locations

Locations (22)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, Aura, France

APHP Saint Antoine; 🇫🇷 Paris, IDF, France

Ch Lons Le Saunier; 🇫🇷 Lons-le-Saunier, France

CHU Rennes; 🇫🇷 Rennes, France

Hôpital Civil de Strasbourg; 🇫🇷 Strasbourg, France

CH Bayeux; 🇫🇷 Bayeux, France

APHP Cochin; 🇫🇷 Paris, IDF, France

CHU bordeaux; 🇫🇷 Bordeaux, France

CHU de Clermont-Ferrand - Service de Neurologie; 🇫🇷 Clermont-Ferrand, Aura, France

APHP Ambroise Paré; 🇫🇷 Boulogne-Billancourt, IDF, France

CHU Amiens; 🇫🇷 Amiens, France

Chu Rouen; 🇫🇷 Rouen, France

CH Voiron; 🇫🇷 Voiron, France

Groupe Hospitalier Paris Saint Joseph; 🇫🇷 Paris, IDf, France

Hospices civils Lyon; 🇫🇷 Bron, France

CHU Limoges; 🇫🇷 Limoges, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU Nîmes; 🇫🇷 Nîmes, France

Chu Toulouse; 🇫🇷 Toulouse, France

CHU Montepllier; 🇫🇷 Montpellier, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Saint Etienne; 🇫🇷 Saint-Étienne, France