Cohort of Chronic Pain Patients

Chronic Pain Clinical Trial

— e-DOL cohort  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04880096
• Other study ID #: RNI 2020 AUTHIER
• Status: Recruiting
• Start date: September 14, 2021
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 04 73 75 11 95
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CH Bayeux	Bayeux
France	CHU bordeaux	Bordeaux
France	APHP Ambroise Paré	Boulogne-Billancourt	IDF
France	Hospices civils Lyon	Bron
France	CHU de Clermont-Ferrand - Service de Neurologie	Clermont-Ferrand	Aura
France	Clermont-Ferrand University Hospital	Clermont-Ferrand	Aura
France	CHU Grenoble	Grenoble
France	CHU Limoges	Limoges
France	Ch Lons Le Saunier	Lons-le-Saunier
France	CHU Montepllier	Montpellier
France	CHU Nantes	Nantes
France	CHU Nîmes	Nîmes
France	APHP Cochin	Paris	IDF
France	APHP Saint Antoine	Paris	IDF
France	Groupe Hospitalier Paris Saint Joseph	Paris	IDf
France	CHU Rennes	Rennes
France	Chu Rouen	Rouen
France	CHU Saint Etienne	Saint-Étienne
France	Hôpital Civil de Strasbourg	Strasbourg
France	Chu Toulouse	Toulouse
France	CH Voiron	Voiron

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Institut ANALGESIA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	multidimensional characterisation of chronic pain patients	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.).	5 years
Secondary	Multivariate descriptive analyses	Study the relationships between the measured criteria	5 years
Secondary	Longitudinal analyses	Describe the distribution and temporal evolution of the measured variables	5 years