NCT03931694

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..

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 7, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

February 7, 2019

Last Update Submit

September 18, 2020

Conditions

Chronic Pain

Keywords

Chronic paine-Health

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (14)

  • Typology of patient responses

    Weekly, up to 6 months

  • Typology of patient responses

    Up to 6 months

  • Typology of patient responses

    Up to 6 months

  • Typology of patient responses

    Up to 6 months

  • Typology of patient responses

    Up to 6 months

  • +9 more secondary outcomes

Study Arms (1)

All patients with chronic pain follow in pain clinic

Device: e-DOL

Interventions

e-DOLDEVICE

e-health program (smartphone and web platform)

All patients with chronic pain follow in pain clinic

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic pain

You may qualify if:

  • All patients with chronic pain
  • patients with and regular users of a smartphone
  • Non-opposition to participation in the study

You may not qualify if:

  • Patient unable to understand or answer questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Chu Amiens

Amiens, France

Location

Ch Bayeux

Bayeux, France

Location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Chu Grenoble

Grenoble, France

Location

Chu Limoges

Limoges, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Chu Nimes

Nîmes, France

Location

AP-HP Ambroise Paré

Paris, France

Location

Ap-Hp Cochin

Paris, France

Location

Ap-Hp Lariboisiere

Paris, France

Location

Chu Rouen

Rouen, France

Location

Chu Toulouse

Toulouse, France

Location

Ch Voiron

Voiron, France

Location

Related Publications (1)

  • 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.

    PMID: 35234654DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Noémie DELAGE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2019

First Posted

April 30, 2019

Study Start

February 6, 2019

Primary Completion

June 4, 2020

Study Completion

June 4, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations

FR(13)