Psycho-social Consequences of Systemic Lupus Erythematosus

Lupus Erythematosus Clinical Trial

Official title:

Psychosocial Consequences of Systemic Lupus Erythematosus: a Study of Patients and Their Spouses Psy-LUP Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03913754
• Other study ID #: 2018-29
• Status: Recruiting
• Start date: June 30, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2019
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Noémie Jourde Chiche
• Phone: 04 91 38 41 38
• Email: Noemie.JOURDE[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus
• Lupus Erythematosus, Systemic

Intervention

Other:
• Psycho-social consequences of lupus erythematosus
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.

Locations

Country	Name	City	State
France	Assitance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the physical, psychological and social impact of chronic diseases	Quality of life scale Short Study Form-36 (SF-36)	12 months