Clinical trial NCT04880096: Cohort of Chronic Pain Patients
Official title: Constitution and Analysis of a Cohort of Patients Followed in Pain Clinics and at Home in Real Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Keywords: Chronic Pain
e-Health
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Institut ANALGESIA
First posted: 2021-05-10
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patiant with chronic pain

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.

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

Primary outcomes:
measure: multidimensional characterisation of chronic pain patients
timeFrame: 5 years
Secondary outcomes:
measure: Multivariate descriptive analyses
timeFrame: 5 years
measure: Longitudinal analyses
timeFrame: 5 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand - Service de Neurologie
state: Aura
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Aura
city: Boulogne-Billancourt
country: France
facility: APHP Ambroise Paré
state: IDF
city: Paris
country: France
facility: APHP Saint Antoine
state: IDF
city: Paris
country: France
facility: APHP Cochin
state: IDF
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: IDf
city: Amiens
country: France
facility: CHU Amiens
city: Bayeux
country: France
facility: CH Bayeux
city: Bordeaux
country: France
facility: CHU bordeaux
city: Bron
country: France
facility: Hospices civils Lyon
city: Grenoble
country: France
facility: CHU Grenoble
city: Limoges
country: France
facility: CHU Limoges
city: Lons-le-Saunier
country: France
facility: Ch Lons Le Saunier
city: Montpellier
country: France
facility: CHU Montepllier
city: Nantes
country: France
facility: CHU Nantes
city: Nîmes
country: France
facility: CHU Nîmes
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: Chu Rouen
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
city: Strasbourg
country: France
facility: Hôpital Civil de Strasbourg
city: Toulouse
country: France
facility: Chu Toulouse
city: Voiron
country: France
facility: CH Voiron
Study officials:
References: