Clinical trial NCT03931694: E-health Tool for Management of Chronic Pain Patients.
Official title: Evaluation of the Feasibility of an E-health Tool in the Follow-up and Characterization of Chronic Pain Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Chronic pain
e-Health
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Institut ANALGESIA
First posted: 2019-04-30
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients 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. 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, Investigator has created e-DOL, a smartphone application for patients and a web platform for physicians. The purpose of this study is to evaluate the feasibility and clinical interest of an e-Health smartphone application for the characterization and follow-up of chronic pain patients..

Detailed description: This first clinical study will assess the acceptability of the tool both by caregivers at the 13 pain clinics and by a panel of 300 patients followed for 6 months. Based on the results of the study (end 2019), investigator will improve the tool in a version 2.0, which will then be evaluated in a large impact study, measuring the intrinsic therapeutic effect of eDOL.

Eligibility criteria: Inclusion Criteria:

* All patients with chronic pain
* patients with 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: Feasibility of the e-health tool
timeFrame: Once, up to 12 months
measure: Feasibility of the e-health tool
timeFrame: Once, up to 12 months
measure: Feasibility of the e-health tool
timeFrame: Once, up to 12 months
Secondary outcomes:
measure: Typology of patient responses
timeFrame: Weekly, up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: Typology of patient responses
timeFrame: Up to 6 months
measure: impact of the eHealth tool
timeFrame: Once, Up to 12 months.
measure: impact of the eHealth tool
timeFrame: Once, up 12 months.
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Bayeux
country: France
facility: Ch Bayeux
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Grenoble
country: France
facility: Chu Grenoble
city: Limoges
country: France
facility: Chu Limoges
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nîmes
country: France
facility: Chu Nimes
city: Paris
country: France
facility: AP-HP Ambroise Paré
city: Paris
country: France
facility: Ap-Hp Cochin
city: Paris
country: France
facility: Ap-Hp Lariboisiere
city: Rouen
country: France
facility: Chu Rouen
city: Toulouse
country: France
facility: Chu Toulouse
city: Voiron
country: France
facility: Ch Voiron
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Noémie DELAGE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerckhove N, Delage N, Cambier S, Cantagrel N, Serra E, Marcaillou F, Maindet C, Picard P, Martine G, Deleens R, Trouvin AP, Fourel L, Espagne-Dubreuilh G, Douay L, Foulon S, Dufraisse B, Gov C, Viel E, Jedryka F, Pouplin S, Lestrade C, Combe E, Perrot S, Perocheau D, De Brisson V, Vergne-Salle P, Mertens P, Pereira B, Djiberou Mahamadou AJ, Antoine V, Corteval A, Eschalier A, Duale C, Attal N, Authier N. eDOL mHealth App and Web Platform for Self-monitoring and Medical Follow-up of Patients With Chronic Pain: Observational Feasibility Study. JMIR Form Res. 2022 Mar 2;6(3):e30052. doi: 10.2196/30052.