E-health Tool for Management of Chronic Pain Patients. (e-DOL)

Evaluation of the Feasibility of an E-health Tool in the Follow-up and Characterization of Chronic Pain Patients.

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..

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: e-DOL

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 Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens
  • Bayeux, France
    • Ch Bayeux
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand
  • Grenoble, France
    • CHU Grenoble
  • Limoges, France
    • Chu Limoges
  • Lyon, France
    • Hospices Civils de Lyon
  • Nîmes, France
    • CHU Nîmes
  • Paris, France
    • AP-HP Ambroise Pare
  • Paris, France
    • AP-HP Cochin
  • Paris, France
    • AP-HP Lariboisiere
  • Rouen, France
    • CHU Rouen
  • Toulouse, France
    • CHU Toulouse
  • Voiron, France
    • CH Voiron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with chronic pain

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients with chronic pain follow in pain clinic	Device: e-DOL; e-health program (smartphone and web platform)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the e-health tool	Feasibility evaluated by analysis of user acceptability (custom questionnaire: ease of use, utility...)	Once, up to 12 months
Feasibility of the e-health tool	Feasibility evaluated by analysis of Number of data completed / missing (% of responses)	Once, up to 12 months
Feasibility of the e-health tool	Feasibility evaluated by analysis of Participation of investigator centres (inclusion rate)	Once, up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Typology of patient responses	Temporal evolution of the pain intensity using 0-10 VAS	Weekly, up to 6 months
Typology of patient responses	Temporal evolution of the anxiety using 0-10 VAS	Up to 6 months
Typology of patient responses	Temporal evolution of the sleep quality using 0-10 VAS	Up to 6 months
Typology of patient responses	Temporal evolution of the mood using 0-10 VAS	Up to 6 months
Typology of patient responses	Temporal evolution of the body comfort using 0-10 VAS	Up to 6 months
Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by Brief Pain Inventory questionnaire	Up to 6 months
Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by Pain Beliefs and Perceptions Inventory questionnaire	Up to 6 months
Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by Medical Outcomes Study-Sleep Scale questionnaire	Up to 6 months
Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by Tampa Scale of Kinesiophobia questionnaire	Up to 6 months
Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by Pain Catastrophizing Scale questionnaire	Up to 6 months
Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by EQ-5D questionnaire	Up to 6 months
Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by ,Hospital Anxiety Depression Scale questionnaire	Up to 6 months
impact of the eHealth tool	evaluation of the impact of the eHealth tool on current practices (clinician's opinion)	Once, Up to 12 months.
impact of the eHealth tool	evaluation of the impact of the eHealth tool on quality of life (patient's opinion)	Once, up 12 months.

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Institut ANALGESIA
• Investigators: Principal Investigator: Noémie DELAGE, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): June 4, 2020
• Study Completion (Actual): June 4, 2020

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Chronic pain; e-Health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CHU-425; 2018-A01790-5546 (Other Identifier: 2018-A01790-5546)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No