Lupus Clinical Trial - Acceptability & Persistence of the Use of a

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Lupus

Clinical Trial Details

NCT number	NCT03953690
Study type	Observational
Source	Centre Hospitalier Universitaire Dijon
Contact
Status	Terminated
Phase
Start date	March 19, 2020
Completion date	December 5, 2022

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms