Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psycho-social Consequences of Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913754
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.

Condition or disease Intervention/treatment
Lupus Erythematosus Other: Psycho-social consequences of lupus erythematosus

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Psychosocial Consequences of Systemic Lupus Erythematosus: a Study of Patients and Their Spouses Psy-LUP Study
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort Intervention/treatment
Lupus Patients with kidneys failure
Assessment of quality of life on everydays life trough questionnare
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.

Lupus Patients without kidneys failure
Assessment of quality of life on everydays life trough questionnare
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.




Primary Outcome Measures :
  1. the physical, psychological and social impact of chronic diseases [ Time Frame: 12 months ]
    Quality of life scale Short Study Form-36 (SF-36)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913754


Contacts
Layout table for location contacts
Contact: Noémie Jourde Chiche 04 91 38 41 38 Noemie.JOURDE@ap-hm.fr
Contact: Patrick Sudour 04 91 38 29 03 promotion.interne@ap-hm.fr

Locations
Layout table for location information
France
Assitance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13000
Contact: Noemie Jourde-Chiche, MD/PhD       noemie.jourde@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille

Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03913754     History of Changes
Other Study ID Numbers: 2018-29
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases