Clinical trial NCT03913754: Psycho-social Consequences of Systemic Lupus Erythematosus
Official title: Psychosocial Consequences of Systemic Lupus Erythematosus: a Study of Patients and Their Spouses Psy-LUP Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Erythematosus
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Detailed description: Systemic lupus erythematosus (SLE) is a rare chronic autoimmune disease (1/2000 inhabitants) that evolves in periods of recurrent remissions. Sufferers are most often young women of childbearing age. SLE affects the life of a couple like family life (financial, emotional, relational or sexual conditions of the couple). In addition, the disease and its treatments can hinder the possibility of building a family project (pregnancy).

The purpose of the Psy-LUP study is to study the impact of SLE on the social participation of patients, that is to say on their ability to get involved in different areas of daily life. These repercussions could be all the more important as lupus disease is active and complicated by severe diseases such as kidney disease. We want to study how sick people and their loved ones (spouse in particular) think about lupus disease, how it fits into their life history, how people have adapted to this disease, and how it affects their lives. could have on their social participation, their social support, their life of couple. The Psy-LUP study will be carried out in different care services, and by telephone interviews at home, with two main axes: (1) a study by questionnaire with patients (n = 100); (2) a qualitative study through research interviews with patients (n = 40) and their spouses (n = 20). The realization of this project will allow us to evaluate and understand the impact of SLE on the life of the couple 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: the physical, psychological and social impact of chronic diseases
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assitance Publique Hôpitaux de Marseille
Study officials:
References: