Psycho-social Consequences of Systemic Lupus Erythematosus

NCT03913754 | Completed DMC

• 1 other identifier: 2018-29
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

this project will allow us to evaluate and understand the impact of SLE on the couple's life and its relational and affective components. In addition, the Psy-LUP study will describe the representations that sick people and their relatives have of lupus disease. All the data collected will make it possible to target interventions with 1) patients and their relatives, in terms of therapeutic education, psychosocial support, support groups (associations); 2) caregivers caring for people with SLE, so that they can integrate the issues of the patient's experience in their care practice and their reflection on therapeutic strategies.

Conditions

Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• the physical, psychological and social impact of chronic diseases

  Quality of life scale Short Study Form-36 (SF-36)

  12 months

Study Arms (2)

Lupus Patients with kidneys failure

Assessment of quality of life on everydays life trough questionnare

Other: Psycho-social consequences of lupus erythematosus

Lupus Patients without kidneys failure

Assessment of quality of life on everydays life trough questionnare

Other: Psycho-social consequences of lupus erythematosus

Interventions

Psycho-social consequences of lupus erythematosus OTHER

It will be necessary to take into account the psychosocial experience of the disease \[47\] and to allow a narrative exploration of this experience and its psycho-social consequences both for the patients and their spouses (ie the experiential dimension of the disease in connection with the life trajectory, the life of a couple, elaborate representations concerning the disease). The purpose of this approach is not only to question the meaning of the disease (beliefs, representations), the psycho-social management of the disease, its inclusion in the socio-cultural condition of the patients, but also to allow an analysis of the inscription. of the disease in the relationship and its implications (relational, affective, sexual) and its impact on the possibilities of social participation.

Lupus Patients with kidneys failure; Lupus Patients without kidneys failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population covered by the QuaNTi Psy-LUP project is that of patients monitored by the Lupus PACA Competence Center, and a cohort of SLE patients with renal impairment (WIN-Lupus trial).

You may qualify if:

• Age\> 18 years
• Presenting an LES according to ACR or SLICC criteria
• Being followed in Marseille in Nephrology or Internal Medicine as part of the Competence Center Lupus PACA
• Having agreed to participate in the study after information

You may not qualify if:

• Minor person
• Person deprived of liberty
• Person not affiliated to a social security scheme

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assitance Publique Hôpitaux de Marseille

Marseille, 13000, France

Location

Related Publications (2)

• Aim MA, Queyrel V, Tieulie N, Chiche L, Faraut J, Manet C, Schleinitz N, Harle JR, Jourde-Chiche N, Dany L. Importance of temporality and context in relation to life habit restrictions among patients with systemic lupus erythematosus: A psychosocial qualitative study. Lupus. 2022 Oct;31(12):1423-1433. doi: 10.1177/09612033221115966. Epub 2022 Aug 2.

  PMID: 35916586 BACKGROUND

• Manet C, Aim MA, Queyrel V, Faraut J, Costedoat-Chalumeau N, Daugas E, Hachulla E, Harle JR, Huart A, Hummel A, Kaplanski G, Mazodier K, Mancini J, Sarrot-Reynauld F, Schleinitz N, Swiader L, Tieulie N, Manet P, Dany L, Chiche L, Jourde-Chiche N. Determinants of social participation in patients living with systemic lupus erythematosus: the Psy-LUP multicentre study. RMD Open. 2025 Jun 25;11(2):e005661. doi: 10.1136/rmdopen-2025-005661.

  PMID: 40562684 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: June 30, 2019
• Primary Completion: April 22, 2020
• Study Completion: April 23, 2020
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

FR (1)