NCT05763225

Validation of Patient E-tool to Measure Systemic Lupus Activity

Validation of the SLEDAI-P/LUPIN Self-questionnaire Completed by the Patient to Measure the Activity of the Systemic Lupus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 450 (actual)
• Sponsor: Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+) · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Validation of a self-questionnaire (SLEDAI-P/LUPIN) completed by the patient to measure the activity of the systemic lupus, in order to improve the patient's empowerment.

Detailed description

Systemic Lupus Erythematosus (SLE) is a rare and chronic autoimmune disease. Disease activity (DA) is marked by remissions, spontaneous relapses or induced by therapeutic modifications. SLE exposes to serious complications requiring close medical follow-up, but flares cannot be predicted and often do not coincide with medical consultations. SLE DA is measured during a consultation using the SLEDAI tool, but cannot be completed by patients. There is therefore high at stake to develop tools allowing patients to measure DA, predict flares and subsequently tailor the medical follow-u to each patient. Using the same framework as a previous nationwide study related to COVID-19 impact (EPICURE survey), we aim to develop and validate, in collaboration with the French national Lupus Reference Centers and Hometrix Health, a patient-tailored tool (SLEDAI-P/LUPIN). SLEDAI-P/LUPIN was designed by expert lupulogist and patients. It is available as a paper questionnaire and a smartphone app. It consists of simple patient-oriented questions allowing numerical score calculation. In order to validate the SLEDAI-P/LUPIN, we will recruit 500 SLE patients who satisfy the 2019 ACR/EULAR classification criteria. All patients will complete the self-questionnaire and have a follow-up consultation with a clinician within 7 days. The validity of the SLEDAI-P self-questionnaire will be assessed by calculating the correlation between SLEDAI-P/LUPIN and the clinical SLEDAI-2K provided by the clinician (blindly of the SLEDAI-P/LUPIN results). We will also collect information about the quality of life via the SF-36 questionnaire to evaluate if the SLEDAI-P/LUPIN predicts patient-reported outcome measures. The results of this survey will permit the validation of the SLEDAI-P/LUPIN as a self-questionnaire carried by the patient. The development of self-administrated disease activity questionnaires such as the SLEDAI-P/LUPIN may allow to better tailor the treatment and follow-up of SLE patients, and empower SLE patients for the control and management of their disease.

Conditions

• Lupus Erythematosus, Systemic

Timeline

• Start date: 2023-02-09
• Primary completion: 2024-06-01
• Completion: 2024-06-15
• First posted: 2023-03-10
• Last updated: 2024-07-31

Locations

31 sites across 3 countries: France, Guadeloupe, Martinique