e-DOL cohort: Cohort of Chronic Pain Patients

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Recruiting

CT.gov ID

NCT04880096

Collaborator

Institut ANALGESIA (Other)

5,000

Enrollment

Locations

59.6

Anticipated Duration (Months)

227.3

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Other: eDOL

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 Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 14, 2021

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
chronic pain patients All adult patients followed-up in participating pain clinics	Other: eDOL e-health tool (mobile app for patients and web platform for caregivers in pain clinics)

Arm

Intervention/Treatment

chronic pain patients

All adult patients followed-up in participating pain clinics

Other: eDOL

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont-Ferrand - Service de Neurologie	Clermont-Ferrand	Aura	France	63000
2	Clermont-Ferrand University Hospital	Clermont-Ferrand	Aura	France	63000
3	APHP Ambroise Paré	Boulogne-Billancourt	IDF	France	92100
4	APHP Saint Antoine	Paris	IDF	France	75012
5	APHP Cochin	Paris	IDF	France	75014
6	Groupe Hospitalier Paris Saint Joseph	Paris	IDf	France	75014
7	CHU Amiens	Amiens		France	80054
8	CH Bayeux	Bayeux		France	14400
9	CHU bordeaux	Bordeaux		France	33000
10	Hospices civils Lyon	Bron		France	69500
11	CHU Grenoble	Grenoble		France	38700
12	CHU Limoges	Limoges		France	87000
13	Ch Lons Le Saunier	Lons-le-Saunier		France	39000
14	CHU Montepllier	Montpellier		France
15	CHU Nantes	Nantes		France	44093
16	CHU Nîmes	Nîmes		France	30029
17	CHU Rennes	Rennes		France	35000
18	Chu Rouen	Rouen		France	76000
19	CHU Saint Etienne	Saint-Étienne		France	42270
20	Hôpital Civil de Strasbourg	Strasbourg		France
21	Chu Toulouse	Toulouse		France	31300
22	CH Voiron	Voiron		France	38500

Sponsors and Collaborators

University Hospital, Clermont-Ferrand
Institut ANALGESIA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT04880096

Other Study ID Numbers:

RNI 2020 AUTHIER

First Posted:

May 10, 2021

Last Update Posted:

Jun 30, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Clermont-Ferrand

Chronic Pain

e-Health

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Jun 30, 2022