Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 3407 for:    Recruiting, Not yet recruiting, Available Studies | Pain

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03931694
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Institut ANALGESIA
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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..


Condition or disease Intervention/treatment
Chronic Pain 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of the Feasibility of an E-health Tool in the Follow-up and Characterization of Chronic Pain Patients.
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with chronic pain
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931694


Contacts
Layout table for location contacts
Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
Chu Amiens Recruiting
Amiens, France
Sub-Investigator: Eric SERRA         
Ch Bayeux Recruiting
Bayeux, France
Sub-Investigator: Claire DELORME         
Chu Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Noémie DELAGE         
Chu Grenoble Recruiting
Grenoble, France
Sub-Investigator: Caroline MAINDET         
Chu Limoges Recruiting
Limoges, France
Sub-Investigator: Pascale VERGNE-SALLE         
Hospices Civils de Lyon Recruiting
Lyon, France
Sub-Investigator: Patrick MERTENS         
Chu Nimes Recruiting
Nîmes, France
Sub-Investigator: Olivier BREDEAU         
AP-HP Ambroise Paré Recruiting
Paris, France
Sub-Investigator: Nadine ATTAL         
Ap-Hp Cochin Recruiting
Paris, France
Sub-Investigator: Serge PERROT         
Ap-Hp Lariboisiere Recruiting
Paris, France
Sub-Investigator: Alain SERRE         
Chu Rouen Recruiting
Rouen, France
Sub-Investigator: Rodrigue DELEENS         
Chu Toulouse Recruiting
Toulouse, France
Sub-Investigator: Nathalie CANTAGREL         
Ch Voiron Recruiting
Voiron, France
Sub-Investigator: Gérard MICK         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Institut ANALGESIA
Investigators
Layout table for investigator information
Principal Investigator: Noémie DELAGE University Hospital, Clermont-Ferrand

Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03931694     History of Changes
Other Study ID Numbers: CHU-425
2018-A01790-5546 ( Other Identifier: 2018-A01790-5546 )
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Chronic pain
e-Health

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms