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Trial record 3 of 907 for:    Lupus

Acceptability and Persistence of the Use of a Patient-centred E-health Tool for Lupus Patients Followed in a Specialised Centre in France (e-LUPUS)

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ClinicalTrials.gov Identifier: NCT03953690
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

Systemic lupus erythematosus (SLE) is a complex disease whose evaluation in daily practice and clinical research requires consideration of several aspects, in particular disease activity and quality of life.

Health systems are increasingly using Patient Reported Outcome measures (PRO) data to measure different dimensions of the disease and its experience.

In addition, there is a growing number of "e-health" tools for patients. Indeed, the collection of health-related data via an electronic system makes it possible to modernise and facilitate communication between patients and doctors within the framework of medical follow-up and therapeutic education. Nevertheless, very few studies measure the acceptability and effective long-term use of such tools, particularly in the context of SLE.

The Sanoïa patient platform is a digital tool already used in therapeutic areas similar to SLE (discoid lupus erythematosus and rheumatoid arthritis), offering a guarantee of safety and a reduced individual cost.

The availability of this health-related quality of life data collection tool via a site and a mobile application adapted to patients with SLE should:

  • Facilitate the collection by patients of their quality of life as part of their routine follow-up (patient access)
  • Limit the impact of patients' clinical profiles on the frequency of the collection of quality of life data
  • Enable internal medicine specialists to systematically use their patients' quality of life data during consultation (physician access).

This study therefore proposes to evaluate this digital platform within the framework of SLE by measuring the distribution of access by physicians according to the data reported by patients and according to the characteristics of the facilities where the subjects were recruited for the study. These data will allow us to evaluate the influence of factors extrinsic to patients on the adoption of the tool. This area has been very poorly evaluated in the few studies that have focused on the adoption of such tools.


Condition or disease Intervention/treatment
Lupus Other: use of e-Health service

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Study Type : Observational
Estimated Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acceptability and Persistence of the Use of a Patient-centred E-health Tool for Lupus Patients Followed in a Specialised Centre in France
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Intervention Details:
  • Other: use of e-Health service
    use of the e-Health e-Lupus account (at least) once a month and encouraged to advise his doctor to consult the entered data before the following consultation


Primary Outcome Measures :
  1. utilization rate of online patient account [ Time Frame: Through study completion, an average of 24 months ]
    rate of use of the patient account at least twice, at least 1 month apart, over a 12-month period



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients attending a consultation in their usual treatment centre
Criteria

Inclusion Criteria:

  • Adult > 18 years old
  • Having given oral consent for participation
  • Confirmed systemic lupus diagnosis (ACR criteria)
  • Regular follow-up in the centre for more than 12 months
  • With Internet access at home
  • Affiliated with national health insurance system or other system

Exclusion Criteria:

  • Persons subject to a legal protection measure (curatorship, guardianship)
  • Persons subject to limited judicial protection
  • Pregnant, postpartum or breastfeeding women
  • Adults who are incapable or unable to express their consent
  • Patients who cannot read French
  • Patients whose cognitive status does not allow them to track their health data on a digital platform
  • Patients to be followed up in another centre within 12 months

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): NCT03953690


Contacts
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Contact: Hervé DEVILLIERS +33 3 80 39 33 79 herve.devilliers@u-bourgogne.fr

Locations
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France
Centre Hospitalier Universitaire Not yet recruiting
Dijon, France, 21079
Contact: Hervé DEVILLIERS    03 80 39 33 79 ext 33    herve.devilliers@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03953690     History of Changes
Other Study ID Numbers: DEVILLIERS 2018
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No