OPTIMISE: Validation of Patient E-tool to Measure Systemic Lupus Activity

Sponsor

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

Overall Status

Not yet recruiting

CT.gov ID

NCT05763225

Collaborator

Hometrix Health SAS (Other)

500

Enrollment

Locations

Anticipated Duration (Months)

38.5

Patients Per Site

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic

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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Minjoz	Besançon	France	25030
2	CHU Bordeaux	Bordeaux	France	33076
3	Service de Médecine interne et maladies infectieuses (Sud) CHU de Bordeaux-GH Sud - Hôpital Haut-Lévêque	Bordeaux	France	33604
4	CHU Dijon Bourgogne - Hôpital François Mitterrand	Dijon	France	21000
5	Et service de médecine interne - CHU Réunion site Nord, St Denis	La Réunion	France	97400
6	Hospices Civils de Lyon	Lyon	France	69003
7	Service de Médecine Interne Hôpital Robert Schuman	Metz	France	57070
8	Service de médecine interne et immunologie clinique CHU de Nancy - Hôpitaux de Brabois	Nancy	France	54511
9	Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix	Paris	France	75013
10	Service de médecine interne CHU de Poitiers	Poitiers	France	86000
11	Département de Médecine Interne du Pr.BENHAMOU CHU DE ROUEN	Rouen	France	76000
12	Strasbourg University Hospital	Strasbourg	France	67000
13	Service de Médecine Interne & Immunologie Clinique Hôpital Bretonneau CHRU de Tours	Tours	France	37044