Lupus ErythematosusNCT03913754
Psycho-social Consequences of Systemic Lupus Erythematosus
An observational study of Lupus Erythematosus, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus
- What is being tested?
- Psycho-social consequences of lupus erythematosus
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2019to 23 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Minor person
- Person deprived of liberty
- Person not affiliated to a social security scheme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Consequences of Systemic Lupus Erythematosus: a Study of Patients and Their Spouses Psy-LUP Study
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.
Read the 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.
- Conditions
- Lupus Erythematosus
- Being tested
- Psycho-social consequences of lupus erythematosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-social consequences of lupus erythematosusOther
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 group | Role | What they receive |
|---|---|---|
| Lupus Patients with kidneys failure | Assessment of quality of life on everydays life trough questionnare Receives: Other: Psycho-social consequences of lupus erythematosus | |
| Lupus Patients without kidneys failure | Assessment of quality of life on everydays life trough questionnare Receives: Other: Psycho-social consequences of lupus erythematosus |
What is being measured
The primary outcome is the main question the study is designed to answer.
the physical, psychological and social impact of chronic diseases
Quality of life scale Short Study Form-36 (SF-36)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start30 Jun 2019
- Primary completion22 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913754
- Sponsor's protocol ID
- 2018-29
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2019
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35916586Manet 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.
PubMed 40562684
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Consequences of Systemic Lupus Erythematosus: a Study of Patients and Their Spouses Psy-LUP Study
- ClinicalTrials.gov ID
- NCT03913754
- Acronym / sponsor ID
- 2018-29
- Conditions
- Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lupus Patients with kidneys failure | – | Other: Psycho-social consequences of lupus erythematosusAssessment of quality of life on everydays life trough questionnare |
| Lupus Patients without kidneys failure | – | Other: Psycho-social consequences of lupus erythematosusAssessment of quality of life on everydays life trough questionnare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Minor person
- Person deprived of liberty
- Person not affiliated to a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-social consequences of lupus erythematosusIt 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. | Other | Lupus Patients with kidneys failure, Lupus Patients without kidneys failure |
Primary outcome
the physical, psychological and social impact of chronic diseases
Time frame: 12 months
Quality of life scale Short Study Form-36 (SF-36)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 35916586Aim 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.
- Background: PubMed 40562684Manet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the physical, psychological and social impact of chronic diseases (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913754, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.