Validation of Patient E-tool to Measure Systemic Lupus Activity

NCT ID: NCT05763225

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2024-06-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of systemic lupus Patient residing in Metropolitan France or in the french Ultra-Marine Departments and Territories Patient who has both completed the SLEDAI-P/LUPIN, SF-12 and been assessed by a specialist via the SLEDAI-2K within 15 days

Exclusion Criteria

Non-lupus patient/participant Patient residing outside France Patient who has not completed the SLEDAI-P/LUPIN OR has not been assessed by a specialist via the SLEDAI-2K within 15 days

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hometrix Health SAS

OTHER

Sponsor Role: collaborator

Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Médecine interne - Centre hospitalier de la Côte Basque

Bayonne, , France

CHU Minjoz

Besançon, , France

CHU Bordeaux

Bordeaux, , France

Service de Médecine interne et maladies infectieuses (Sud) CHU de Bordeaux-GH Sud - Hôpital Haut-Lévêque

Bordeaux, , France

CHU de Clermont-Ferrand - Hôpital Gabriel Montpied Médecine Interne

Clermont-Ferrand, , France

Hopital Louis Pasteur

Colmar, , France

CHU Dijon Bourgogne - Hôpital François Mitterrand

Dijon, , France

Et service de médecine interne - CHU Réunion site Nord, St Denis

La Réunion, , France

Hospices Civils de Lyon

Lyon, , France

Hopital de la Croix Rousse - Lyon, Service de médecine Interne

Lyon, , France

Médecine Interne - Hôpital Saint Joseph Saint Luc

Lyon, , France

Hôpitaux Universitaires de Marseille Conception - Médecine interne, Immunologie et Immunologie clinique

Marseille, , France

Service de Médecine Interne de l'Hôpital de la Timone

Marseille, , France

Service de médecine interne - Hôpital Nord

Marseille, , France

Service de Médecine Interne Hôpital Robert Schuman

Metz, , France

CHU de Nancy, Hôpital Brabois

Nancy, , France

Service de médecine interne et immunologie clinique CHU de Nancy - Hôpitaux de Brabois

Nancy, , France

CHU de Nantes Hôtel Dieu- Centre de compétences maladies systémiques et auto-immunes rares

Nantes, , France

Hôpital Saint-Louis - Service de Médecine Interne, Maladies Systémiques

Paris, , France

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix

Paris, , France

Hôpital Tenon - Service de dermatologie, médecine vasculaire et allergologie

Paris, , France

Hôpital Bicêtre - Service de Rhumatologie

Paris, , France

Service de médecine interne CHU de Poitiers

Poitiers, , France

Hopital Robert Debre Chu Reims

Reims, , France

Département de Médecine Interne du Pr.BENHAMOU CHU DE ROUEN

Rouen, , France

Strasbourg University Hospital

Strasbourg, , France

Hôpital civil - Immunologie Clinique et Médecine Interne

Strasbourg, , France

Service de Médecine Interne & Immunologie Clinique Hôpital Bretonneau CHRU de Tours

Tours, , France

CH de Valence - Valence, Service de médecine interne

Valence, , France

Centre Hospitalier de la Basse Terre

Basse-Terre, , Guadeloupe

Service de Rhumatologie - Médecine Interne 5D CHU de Martinique - Hôpital P. Zobda-Quitman

Martinique, , Martinique

Countries

France; Guadeloupe; Martinique

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Related Links

https://lupusplus.com/

Promoter website

Other Identifiers

nZein

Identifier Type: -

Identifier Source: org_study_id