E-health Tool for Management of Chronic Pain Patients.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: e-DOL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients with chronic pain follow in pain clinic<br> | Device: e-DOL<br>* e-health program (smartphone and web platform)<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, e-Health