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

January 30, 2024 updated by: Association Francaise du Lupus et Autres Maladies Auto-immunes (AFL+)

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bayonne, France, 64109
        • Recruiting
        • Médecine interne - Centre hospitalier de la Côte Basque
        • Contact:
      • Besançon, France, 25030
      • Bordeaux, France, 33076
      • Bordeaux, France, 33604
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • CHU de Clermont-Ferrand - Hôpital Gabriel Montpied Médecine Interne
        • Contact:
      • Colmar, France, 68024
      • Dijon, France, 21000
      • La Réunion, France, 97400
        • Recruiting
        • Et service de médecine interne - CHU Réunion site Nord, St Denis
        • Contact:
        • Sub-Investigator:
          • Frederic Renou, Investigator
      • Lyon, France, 69003
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Sub-Investigator:
          • Arnaud Hot, Investigator
      • Lyon, France, 69004
        • Recruiting
        • Hopital de la Croix Rousse - Lyon, Service de médecine Interne
        • Contact:
      • Lyon, France, 69007
      • Marseille, France, 13005
        • Recruiting
        • Hôpitaux Universitaires de Marseille Conception - Médecine interne, Immunologie et Immunologie clinique
        • Contact:
      • Marseille, France, 13005
        • Recruiting
        • Service de Médecine Interne de l'Hôpital de la Timone
        • Contact:
      • Marseille, France, 13915
        • Recruiting
        • Service de medecine interne - Hôpital Nord
        • Contact:
      • Metz, France, 57070
        • Recruiting
        • Service de Médecine Interne Hôpital Robert Schuman
        • Contact:
      • Nancy, France, 54111
        • Recruiting
        • CHU de Nancy, Hôpital Brabois
        • Contact:
      • Nancy, France, 54511
        • Recruiting
        • Service de médecine interne et immunologie clinique CHU de Nancy - Hôpitaux de Brabois
        • Contact:
        • Sub-Investigator:
          • Thomas Moulinet, Investigator
      • Nantes, France, 44000
        • Recruiting
        • CHU de Nantes Hôtel Dieu- Centre de compétences maladies systémiques et auto-immunes rares
        • Contact:
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis - Service de Médecine Interne, Maladies Systémiques
        • Contact:
      • Paris, France, 75013
        • Recruiting
        • Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix
        • Contact:
      • Paris, France, 75020
        • Recruiting
        • Hôpital Tenon - Service de dermatologie, médecine vasculaire et allergologie
        • Contact:
        • Sub-Investigator:
          • Patricia Senet, Investigator
      • Paris, France, 94270
        • Recruiting
        • Hôpital Bicêtre - Service de Rhumatologie
        • Contact:
        • Sub-Investigator:
          • Raphaele Seror, Investigator
      • Poitiers, France, 86000
        • Recruiting
        • Service de médecine interne CHU de Poitiers
        • Contact:
        • Sub-Investigator:
          • Pascal Roblot, Investigator
        • Sub-Investigator:
          • Mathieu Puyade, Investigator
      • Reims, France, 51092
        • Recruiting
        • Hopital Robert Debre Chu Reims
        • Contact:
        • Sub-Investigator:
          • Amélie servettaz, Investigator
      • Rouen, France, 76000
        • Recruiting
        • Département de Médecine Interne du Pr.BENHAMOU CHU DE ROUEN
        • Contact:
      • Strasbourg, France, 67000
      • Strasbourg, France, 67091
      • Tours, France, 37044
        • Recruiting
        • Service de Médecine Interne & Immunologie Clinique Hôpital Bretonneau CHRU de Tours
        • Contact:
        • Sub-Investigator:
          • Elisabeth Diot, Investigator
      • Valence, France, 26000
        • Recruiting
        • CH de Valence - Valence, Service de médecine interne
        • Contact:
  • Guadeloupe
  • Martinique
      • Martinique, Martinique, 97261
        • Recruiting
        • Service de Rhumatologie - Médecine Interne 5D CHU de Martinique - Hôpital P. Zobda-Quitman
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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)
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life evaluation via the 36-Item Short Form Health Survey (SF-36)
Time Frame: 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)
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Hometrix Health SAS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nZein

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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