Clinical trial NCT05763225: Validation of Patient E-tool to Measure Systemic Lupus Activity
Official title: Validation of the SLEDAI-P/LUPIN Self-questionnaire Completed by the Patient to Measure the Activity of the Systemic Lupus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Erythematosus, Systemic
Keywords: Patient-reported outcomes
Disease activity
SLEDAI
Patient empowerment
Lupus Erythematosus Systemic
SLEDAI-P
LUPIN
Lead sponsor: Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+)
Sponsor class: OTHER
Collaborators: name: Hometrix Health SAS
First posted: 2023-03-10
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This survey will be distributed to the entire French population affected by lupus (metropolitan and overseas territories).

The study is anonymous from the beginning and there will be no way to trace the identity of the participants.

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.

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

Primary outcomes:
measure: Statistical correlation between the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) questionnaire and the patients reported outcome SLEDAI for Patient / LUpus Patient INdex (SLEDAI-P/LUPIN)
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Quality of life evaluation via the 36-Item Short Form Health Survey (SF-36)
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Médecine interne - Centre hospitalier de la Côte Basque
city: Besançon
country: France
facility: CHU Minjoz
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Bordeaux
country: France
facility: Service de Médecine interne et maladies infectieuses (Sud) CHU de Bordeaux-GH Sud - Hôpital Haut-Lévêque
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand - Hôpital Gabriel Montpied Médecine Interne
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Dijon
country: France
facility: CHU Dijon Bourgogne - Hôpital François Mitterrand
city: La Réunion
country: France
facility: Et service de médecine interne - CHU Réunion site Nord, St Denis
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Lyon
country: France
facility: Hopital de la Croix Rousse - Lyon, Service de médecine Interne
city: Lyon
country: France
facility: Médecine Interne - Hôpital Saint Joseph Saint Luc
city: Marseille
country: France
facility: Hôpitaux Universitaires de Marseille Conception - Médecine interne, Immunologie et Immunologie clinique
city: Marseille
country: France
facility: Service de Médecine Interne de l'Hôpital de la Timone
city: Marseille
country: France
facility: Service de médecine interne - Hôpital Nord
city: Metz
country: France
facility: Service de Médecine Interne Hôpital Robert Schuman
city: Nancy
country: France
facility: CHU de Nancy, Hôpital Brabois
city: Nancy
country: France
facility: Service de médecine interne et immunologie clinique CHU de Nancy - Hôpitaux de Brabois
city: Nantes
country: France
facility: CHU de Nantes Hôtel Dieu- Centre de compétences maladies systémiques et auto-immunes rares
city: Paris
country: France
facility: Hôpital Saint-Louis - Service de Médecine Interne, Maladies Systémiques
city: Paris
country: France
facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix
city: Paris
country: France
facility: Hôpital Tenon - Service de dermatologie, médecine vasculaire et allergologie
city: Paris
country: France
facility: Hôpital Bicêtre - Service de Rhumatologie
city: Poitiers
country: France
facility: Service de médecine interne CHU de Poitiers
city: Reims
country: France
facility: Hopital Robert Debre Chu Reims
city: Rouen
country: France
facility: Département de Médecine Interne du Pr.BENHAMOU CHU DE ROUEN
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Strasbourg
country: France
facility: Hôpital civil - Immunologie Clinique et Médecine Interne
city: Tours
country: France
facility: Service de Médecine Interne & Immunologie Clinique Hôpital Bretonneau CHRU de Tours
city: Valence
country: France
facility: CH de Valence - Valence, Service de médecine interne
city: Basse-Terre
country: Guadeloupe
facility: Centre Hospitalier de la Basse Terre
city: Martinique
country: Martinique
facility: Service de Rhumatologie - Médecine Interne 5D CHU de Martinique - Hôpital P. Zobda-Quitman
Study officials:
References:
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