Systemic Auto-immune DiseasesQUALIMAIRAUNCT02855840
Auto-immune Diseases and Quality of Life
An observational study of Systemic Auto-immune Diseases and Quality of Life, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM) are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for 100 000 inhabitants in France. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Auto-immune Diseases, Quality of Life
- What is being tested?
- completion of the quality of life questionnaire
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2015to Mar 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM)
Who may be able to join
- For all patients:
- Patients aged 18 to 75 years
- Patients able to understand written and spoken French
- Patients who have been given oral and written information about the research
- For patients with SLE:
- SLE defined by American College of Rheumatology (ACR) 1997 criteria
Show all 10Show fewer
- For patients with systemic sclerosis:
- SSc according to the Leroy or American Rheumatism Association (ARA) criteria
- For patients with IM:
- IM according to the Trojanov criteria
Who cannot join
- Refusal to take part in the study
- Cognitive/psychological status incompatible with interviews
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Study of the Consequences of Auto-immune Diseases on Quality of Life
Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM) are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for 100 000 inhabitants in France. These diseases belong to the group of auto-immune diseases and require specialized follow-up in an expert centre. The repercussions of SLE, Ssc and IM on the everyday life of patients are heavy, and notably linked to skin involvement, to diminished functional capacities and psychological problems. The vast majority of these diseases concern middle-aged, professionally-active individuals, for whom the socio-professional repercussions are major and too often neglected. The aim of this study is to analyse the consequences of auto-immune diseases on quality of life. Current quality of life questionnaires are not suitable, and do not reveal the reality of the situation and its different nuances. In this research, the quality of life of patients will be envisaged through their everyday lives. How do these patients construct the social reality of the disease? How do they perceive their health status and their social situation? How do they organize their everyday lives around the disease: work, leisure, relationships with their entourage... ?
- Conditions
- Systemic Auto-immune Diseases, Quality of Life
- Being tested
- completion of the quality of life questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
completion of the quality of life questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| systemic lupus erythematous | Not described Receives: Other: completion of the quality of life questionnaire | |
| systemic sclerosis | Not described Receives: Other: completion of the quality of life questionnaire | |
| inflammatory myopathy | Not described Receives: Other: completion of the quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
semi-directive individual interviews in the 3 groups of patients
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start2 Mar 2015
- Primary completionMar 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Auto-immune DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855840
- Sponsor's protocol ID
- DEVILLIERS FMR 2014
- Acronym
- QUALIMAIRAU
- Status last verified
- Oct 2017
- First submitted
- 28 Jul 2016
- Last updated
- 10 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study of the Consequences of Auto-immune Diseases on Quality of Life
- ClinicalTrials.gov ID
- NCT02855840
- Acronym / sponsor ID
- QUALIMAIRAU / DEVILLIERS FMR 2014
- Conditions
- Systemic Auto-immune Diseases, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Aug 2016 (estimated)
- 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.
Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM) are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for 100 000 inhabitants in France. These diseases belong to the group of auto-immune diseases and require specialized follow-up in an expert centre. The repercussions of SLE, Ssc and IM on the everyday life of patients are heavy, and notably linked to skin involvement, to diminished functional capacities and psychological problems. The vast majority of these diseases concern middle-aged, professionally-active individuals, for whom the socio-professional repercussions are major and too often neglected. The aim of this study is to analyse the consequences of auto-immune diseases on quality of life. Current quality of life questionnaires are not suitable, and do not reveal the reality of the situation and its different nuances. In this research, the quality of life of patients will be envisaged through their everyday lives. How do these patients construct the social reality of the disease? How do they perceive their health status and their social situation? How do they organize their everyday lives around the disease: work, leisure, relationships with their entourage... ?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| systemic lupus erythematous | – | Other: completion of the quality of life questionnaire |
| systemic sclerosis | – | Other: completion of the quality of life questionnaire |
| inflammatory myopathy | – | Other: completion of the quality of life questionnaire |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM)
Key inclusion criteria (10 listed)
- For all patients:
- Patients aged 18 to 75 years
- Patients able to understand written and spoken French
- Patients who have been given oral and written information about the research
- SLE defined by American College of Rheumatology (ACR) 1997 criteria
Key exclusion criteria (2 listed)
- Refusal to take part in the study
- Cognitive/psychological status incompatible with interviews
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 |
|---|---|---|
| completion of the quality of life questionnaire | Other | inflammatory myopathy, systemic lupus erythematous, systemic sclerosis |
Primary outcome
semi-directive individual interviews in the 3 groups of patients
Time frame: day one
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 10 Oct 2017.
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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 Systemic Auto-immune Diseases and Quality of Life, run by Centre Hospitalier Universitaire Dijon 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 10 inclusion and 2 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 10 Oct 2017. 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?
semi-directive individual interviews in the 3 groups of patients (time frame: day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2017.