Lupus Erythematosus, Systemic
Conditions
Keywords
Patient-reported outcomes, Disease activity, SLEDAI, Patient empowerment, Lupus Erythematosus Systemic, SLEDAI-P, LUPIN
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.
Interventions
None listed
Sponsors
Hometrix Health SAS
Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
France, Guadeloupe, Martinique
Outcome results
None listed