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NCT Number: NCT03931694

E-health Tool for Management 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..

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Amiens, Amiens, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

e-DOL

Device

e-health program (smartphone and web platform)

Primary outcomes

  1. Feasibility of the e-health tool

    Time frame: Once, up to 12 months

    Feasibility evaluated by analysis of user acceptability (custom questionnaire: ease of use, utility...)

  2. Feasibility of the e-health tool

    Time frame: Once, up to 12 months

    Feasibility evaluated by analysis of Number of data completed / missing (% of responses)

  3. Feasibility of the e-health tool

    Time frame: Once, up to 12 months

    Feasibility evaluated by analysis of Participation of investigator centres (inclusion rate)

Secondary outcomes

  1. Typology of patient responses

    Time frame: Weekly, up to 6 months

    Temporal evolution of the pain intensity using 0-10 VAS

  2. Typology of patient responses

    Time frame: Up to 6 months

    Temporal evolution of the anxiety using 0-10 VAS

  3. Typology of patient responses

    Time frame: Up to 6 months

    Temporal evolution of the sleep quality using 0-10 VAS

  4. Typology of patient responses

    Time frame: Up to 6 months

    Temporal evolution of the mood using 0-10 VAS

  5. Typology of patient responses

    Time frame: Up to 6 months

    Temporal evolution of the body comfort using 0-10 VAS

  6. Typology of patient responses

    Time frame: Up to 6 months

    temporal evolution of the chronic pain symptoms and related-comorbidities by Brief Pain Inventory questionnaire

  7. Typology of patient responses

    Time frame: Up to 6 months

    temporal evolution of the chronic pain symptoms and related-comorbidities by Pain Beliefs and Perceptions Inventory questionnaire

  8. Typology of patient responses

    Time frame: Up to 6 months

    temporal evolution of the chronic pain symptoms and related-comorbidities by Medical Outcomes Study-Sleep Scale questionnaire

  9. Typology of patient responses

    Time frame: Up to 6 months

    temporal evolution of the chronic pain symptoms and related-comorbidities by Tampa Scale of Kinesiophobia questionnaire

  10. Typology of patient responses

    Time frame: Up to 6 months

    temporal evolution of the chronic pain symptoms and related-comorbidities by Pain Catastrophizing Scale questionnaire

  11. Typology of patient responses

    Time frame: Up to 6 months

    temporal evolution of the chronic pain symptoms and related-comorbidities by EQ-5D questionnaire

  12. Typology of patient responses

    Time frame: Up to 6 months

    temporal evolution of the chronic pain symptoms and related-comorbidities by ,Hospital Anxiety Depression Scale questionnaire

  13. impact of the eHealth tool

    Time frame: Once, Up to 12 months.

    evaluation of the impact of the eHealth tool on current practices (clinician's opinion)

  14. impact of the eHealth tool

    Time frame: Once, up 12 months.

    evaluation of the impact of the eHealth tool on quality of life (patient's opinion)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Institut ANALGESIA

Registry information

Official study title

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

Acronym: e-DOL

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2019
Registry last updated
Sep 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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