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Psycho-social Consequences of Systemic Lupus Erythematosus

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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

Tracking Information
First Submitted Date April 10, 2019
First Posted Date April 12, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date June 30, 2019
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2019)
the physical, psychological and social impact of chronic diseases [ Time Frame: 12 months ]
Quality of life scale Short Study Form-36 (SF-36)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03913754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
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).
Condition Lupus Erythematosus
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.
Study Groups/Cohorts
  • Lupus Patients with kidneys failure
    Assessment of quality of life on everydays life trough questionnare
    Intervention: Other: Psycho-social consequences of lupus erythematosus
  • Lupus Patients without kidneys failure
    Assessment of quality of life on everydays life trough questionnare
    Intervention: Other: Psycho-social consequences of lupus erythematosus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 11, 2019)
160
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2021
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03913754
Other Study ID Numbers 2018-29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor Assistance Publique Hopitaux De Marseille
Collaborators Not Provided
Investigators Not Provided
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date April 2019