Validation of Patient E-tool to Measure Systemic Lupus Activity

Completed

• Conditions: Lupus Erythematosus, Systemic

• Registration Number: NCT05763225
• Lead Sponsor: Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+)

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.

Study Timeline

• Study Start: 2023-02-09
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-10
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	through study completion, an average of 6 months	Patients reported outcome score versus clinical SLEDAI score, Maximum delay between the two surveys is 7 days. score 0-105 (the highest score represents the highest disease activity)

Secondary Outcome Measures

Name	Time	Method
Quality of life evaluation via the 36-Item Short Form Health Survey (SF-36)	through study completion, an average of 6 months	The SF-36 has 8 subscales (Physical activity; Limitations due to physical condition; Each of the 8 summary scores is linearly transformed on a scale from 0 (negative to health) to 100 (positive to health)Perceived health; Vitality; Life and relationships with others; Limitations due to psychological condition; Psychological health; Change in perceived health)

Trial Locations

Locations (31)

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

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