E-health Tool for Management of Chronic Pain Patients.

Chronic Pain Clinical Trial

— e-DOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931694
• Other study ID #: CHU-425
• Secondary ID: 2018-A01790-5546
• Status: Completed
• Start date: February 6, 2019
• Est. completion date: June 4, 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 4, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• e-DOL
e-health program (smartphone and web platform)

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	Ch Bayeux	Bayeux
France	Chu Clermont-Ferrand	Clermont-Ferrand
France	Chu Grenoble	Grenoble
France	Chu Limoges	Limoges
France	Hospices Civils de Lyon	Lyon
France	Chu Nimes	Nîmes
France	AP-HP Ambroise Paré	Paris
France	Ap-Hp Cochin	Paris
France	Ap-Hp Lariboisiere	Paris
France	Chu Rouen	Rouen
France	Chu Toulouse	Toulouse
France	Ch Voiron	Voiron

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Institut ANALGESIA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the e-health tool	Feasibility evaluated by analysis of user acceptability (custom questionnaire: ease of use, utility...)	Once, up to 12 months
Primary	Feasibility of the e-health tool	Feasibility evaluated by analysis of Number of data completed / missing (% of responses)	Once, up to 12 months
Primary	Feasibility of the e-health tool	Feasibility evaluated by analysis of Participation of investigator centres (inclusion rate)	Once, up to 12 months
Secondary	Typology of patient responses	Temporal evolution of the pain intensity using 0-10 VAS	Weekly, up to 6 months
Secondary	Typology of patient responses	Temporal evolution of the anxiety using 0-10 VAS	Up to 6 months
Secondary	Typology of patient responses	Temporal evolution of the sleep quality using 0-10 VAS	Up to 6 months
Secondary	Typology of patient responses	Temporal evolution of the mood using 0-10 VAS	Up to 6 months
Secondary	Typology of patient responses	Temporal evolution of the body comfort using 0-10 VAS	Up to 6 months
Secondary	Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by Brief Pain Inventory questionnaire	Up to 6 months
Secondary	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
Secondary	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
Secondary	Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by Tampa Scale of Kinesiophobia questionnaire	Up to 6 months
Secondary	Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by Pain Catastrophizing Scale questionnaire	Up to 6 months
Secondary	Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by EQ-5D questionnaire	Up to 6 months
Secondary	Typology of patient responses	temporal evolution of the chronic pain symptoms and related-comorbidities by ,Hospital Anxiety Depression Scale questionnaire	Up to 6 months
Secondary	impact of the eHealth tool	evaluation of the impact of the eHealth tool on current practices (clinician's opinion)	Once, Up to 12 months.
Secondary	impact of the eHealth tool	evaluation of the impact of the eHealth tool on quality of life (patient's opinion)	Once, up 12 months.