E-health Tool for Management of Chronic Pain Patients.

Completed

• Conditions: Chronic Pain
• Interventions: Device: e-DOL

• Registration Number: NCT03931694
• 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. 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.

Study Timeline

• Study Start: 2019-02-06
• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-04-30
• Primary Completion: 2020-06-04
• Study Completion: 2020-06-04
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients with chronic pain follow in pain clinic	e-DOL	-

Primary Outcome Measures

Name	Time	Method
Feasibility of the e-health tool	Once, up to 12 months	Feasibility evaluated by analysis of Participation of investigator centres (inclusion rate)

Secondary Outcome Measures

Name	Time	Method
Typology of patient responses	Up to 6 months	temporal evolution of the chronic pain symptoms and related-comorbidities by ,Hospital Anxiety Depression Scale questionnaire
impact of the eHealth tool	Once, up 12 months.	evaluation of the impact of the eHealth tool on quality of life (patient's opinion)

Trial Locations

Locations (13)

Chu Amiens; 🇫🇷 Amiens, France

AP-HP Ambroise Paré; 🇫🇷 Paris, France

Ch Bayeux; 🇫🇷 Bayeux, France

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Chu Grenoble; 🇫🇷 Grenoble, France

Chu Limoges; 🇫🇷 Limoges, France

Chu Nimes; 🇫🇷 Nîmes, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Chu Rouen; 🇫🇷 Rouen, France

Ap-Hp Cochin; 🇫🇷 Paris, France

Ap-Hp Lariboisiere; 🇫🇷 Paris, France

Ch Voiron; 🇫🇷 Voiron, France

Chu Toulouse; 🇫🇷 Toulouse, France