Systemic Lupus ErthematosusRAISENCT06642870
Rare AutoImmune SElf-management Programme Development
An observational study of Systemic Lupus Erthematosus and Systemic Vasculitis, run by University of the West of England at 1 site in United Kingdom.
Trial summary
The rare autoimmune rheumatic diseases (RAIRDs) are life-long multi-system diseases that are life or organ threatening. RAIRDs can impair quality of life similar to chronic diseases such as heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erthematosus, Systemic Vasculitis, Inflammatory Myositis
- What is being tested?
- Non-interventional study
- How many people
- 360 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2024to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited via NHS Rheumatology sites, local or national registries, community centres, social media and networks for each focus group in Bristol, Weston and Leeds
Who may be able to join
- Diagnosis of a rare rheumatic condition made by hospital doctor or secondary care: including lupus, systemic vasculitis, myositis, Sjogren syndrome (participant self-report)
- Ability to give informed consent (with translation support if needed)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jen Orme contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of the West of England/ Bristol Royal Infirmary
Bristol, BS2 8HW
Joanna Robson, Jo.Robson@uwe.ac.uk
Jen Orme, Jen.Orme@uwe.ac.uk
About this study
Official title: Rare Autoimmune Self-management Programme Development
The rare autoimmune rheumatic diseases (RAIRDs) are life-long multi-system diseases that are life or organ threatening. RAIRDs can impair quality of life similar to chronic diseases such as heart failure. The aim of the study is to explore content and structure of a support programme for people with RAIRDs in focus groups and survey meetings.
Read the detailed description
This project aims to provide self-management and psychological support for people with rare autoimmune rheumatic diseases. The first aim is to ensure that the support provided is relevant for all people, through reaching people who may not have been involved in research before. The second aim is to get agreement for the content and structure of this support from people with these diseases and healthcare teams across the UK.
The rare autoimmune rheumatic diseases include systemic lupus erythematosus, vasculitis, scleroderma, myositis and Sjogren's syndrome. They can affect people of any age and can be fatal. They often have a negative impact on peoples' quality of life (social, work and family life).
Information was gathered from six online meetings with groups of people who have these conditions. People wanted to know the truth about their disease and treatment, alongside help adapting to living with a rare and serious disease. A survey of NHS rheumatology departments shows that the majority (80%) do not provide support to help patients deal with the impact of living with one of these diseases.
Firstly, six groups of patients in total (2 each in Bristol, Weston-Super-Mare and Leeds) will be organised with the help of community groups. Focus groups will help gather a range of views regarding support needs.
Secondly, a UK-wide patient survey of support needs will be conducted, translated into the ten most spoken languages in the UK. Paper versions will be available in NHS rheumatology departments, and an online version will be shared through patient charities.
Lastly, survey results and group responses will be used to build a picture of the type of support needed and how to achieve this in practice. The research team will present the results to the patient partners involved, charities, NHS management and healthcare professionals asking the question: How can support be achieved for patients with rare rheumatic diseases within the current NHS? The research team will then make changes to the support programme based on the feedback received.
The researcher leading the patient and public involvement will work closely with community groups. The three patient partners, who have lived experience (one vasculitis and two lupus patients) will work within the research team throughout the life of the project and will take part in all decision making. A group will be formed from patient participants and patient research partners to help design the next steps of the support programme together.
Patient research partners will help design how the outcome of this research will be shared with healthcare professionals and patients. This will include publications, lay summaries shared by patient organisations and presentations at conferences and community events.
- Conditions
- Systemic Lupus Erthematosus, Systemic Vasculitis, Inflammatory Myositis, Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV), Sjogren Syndrome
- Being tested
- Non-interventional study
- Keywords
- Rare autoimmune rheumatic diseases, Self-management, Psychological support
- Medical subject headings
- Systemic Vasculitis, Scleroderma, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
The study will consist of focus groups and a large scale patient survey
| Study group | Role | What they receive |
|---|---|---|
| Study involves a series of focus groups followed by a cross-sectional survey of people with RAIRDs | Systemic lupus erythematosus, systemic vasculitis, inflammatory myositis, systemic sclerosis, Sjogren's syndrome, ANCA-associated vasculitis. Receives: Other: Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-management/efficacy PROM
This study involves qualitative research. The focus group phase will not include outcome measurements. In the cross-sectional survey participants will be asked two questions about self-management and efficacy descriptively to describe the cohort/people who take part
Measured: In year 1 during the cross-sectional survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErthematosusStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the West of England
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Sponsor
- Investigators
- Joanna Robson, Principal investigator, University of the West of England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642870
- Sponsor's protocol ID
- IRAS number 336948
- Acronym
- RAISE
- Status last verified
- Oct 2024
- First submitted
- 9 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not an interventional study
Publications
Petrocchi V, Visintini E, De Marchi G, Quartuccio L, Palese A. Patient Experiences of Systemic Lupus Erythematosus: Findings From a Systematic Review, Meta-Summary, and Meta-Synthesis. Arthritis Care Res (Hoboken). 2022 Nov;74(11):1813-1821. doi: 10.1002/acr.24639. Epub 2022 Jul 13.
PubMed 34133081Fernandez M, Alarcon GS, Calvo-Alen J, Andrade R, McGwin G Jr, Vila LM, Reveille JD; LUMINA Study Group. A multiethnic, multicenter cohort of patients with systemic lupus erythematosus (SLE) as a model for the study of ethnic disparities in SLE. Arthritis Rheum. 2007 May 15;57(4):576-84. doi: 10.1002/art.22672.
PubMed 17471524Jolly M. How does quality of life of patients with systemic lupus erythematosus compare with that of other common chronic illnesses? J Rheumatol. 2005 Sep;32(9):1706-8.
PubMed 16142864Bowman SJ, St Pierre Y, Sutcliffe N, Isenberg DA, Goldblatt F, Price E, Hamburger J, Richards A, Rauz S, Regan M, Rigby S, Jones A, Mulherin D, Clarke AE. Estimating indirect costs in primary Sjogren's syndrome. J Rheumatol. 2010 May;37(5):1010-5. doi: 10.3899/jrheum.090734. Epub 2010 Apr 1.
PubMed 20360188Quaresma M, Coleman MP, Rachet B. 40-year trends in an index of survival for all cancers combined and survival adjusted for age and sex for each cancer in England and Wales, 1971-2011: a population-based study. Lancet. 2015 Mar 28;385(9974):1206-18. doi: 10.1016/S0140-6736(14)61396-9. Epub 2014 Dec 3.
PubMed 25479696Flossmann O, Berden A, de Groot K, Hagen C, Harper L, Heijl C, Hoglund P, Jayne D, Luqmani R, Mahr A, Mukhtyar C, Pusey C, Rasmussen N, Stegeman C, Walsh M, Westman K; European Vasculitis Study Group. Long-term patient survival in ANCA-associated vasculitis. Ann Rheum Dis. 2011 Mar;70(3):488-94. doi: 10.1136/ard.2010.137778. Epub 2010 Nov 24.
PubMed 21109517Gaubitz M. Epidemiology of connective tissue disorders. Rheumatology (Oxford). 2006 Oct;45 Suppl 3:iii3-4. doi: 10.1093/rheumatology/kel282.
PubMed 16987829
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rare Autoimmune Self-management Programme Development
- ClinicalTrials.gov ID
- NCT06642870
- Acronym / sponsor ID
- RAISE / IRAS number 336948
- Conditions
- Systemic Lupus Erthematosus, Systemic Vasculitis, Inflammatory Myositis, Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV), Sjogren Syndrome
- Keywords
- Rare autoimmune rheumatic diseases, Self-management, Psychological support
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of the West of EnglandUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 Oct 2024 (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.
The rare autoimmune rheumatic diseases (RAIRDs) are life-long multi-system diseases that are life or organ threatening. RAIRDs can impair quality of life similar to chronic diseases such as heart failure. The aim of the study is to explore content and structure of a support programme for people with RAIRDs in focus groups and survey meetings.
Detailed description
This project aims to provide self-management and psychological support for people with rare autoimmune rheumatic diseases. The first aim is to ensure that the support provided is relevant for all people, through reaching people who may not have been involved in research before. The second aim is to get agreement for the content and structure of this support from people with these diseases and healthcare teams across the UK.
The rare autoimmune rheumatic diseases include systemic lupus erythematosus, vasculitis, scleroderma, myositis and Sjogren's syndrome. They can affect people of any age and can be fatal. They often have a negative impact on peoples' quality of life (social, work and family life).
Information was gathered from six online meetings with groups of people who have these conditions. People wanted to know the truth about their disease and treatment, alongside help adapting to living with a rare and serious disease. A survey of NHS rheumatology departments shows that the majority (80%) do not provide support to help patients deal with the impact of living with one of these diseases.
Firstly, six groups of patients in total (2 each in Bristol, Weston-Super-Mare and Leeds) will be organised with the help of community groups. Focus groups will help gather a range of views regarding support needs.
Secondly, a UK-wide patient survey of support needs will be conducted, translated into the ten most spoken languages in the UK. Paper versions will be available in NHS rheumatology departments, and an online version will be shared through patient charities.
Lastly, survey results and group responses will be used to build a picture of the type of support needed and how to achieve this in practice. The research team will present the results to the patient partners involved, charities, NHS management and healthcare professionals asking the question: How can support be achieved for patients with rare rheumatic diseases within the current NHS? The research team will then make changes to the support programme based on the feedback received.
The researcher leading the patient and public involvement will work closely with community groups. The three patient partners, who have lived experience (one vasculitis and two lupus patients) will work within the research team throughout the life of the project and will take part in all decision making. A group will be formed from patient participants and patient research partners to help design the next steps of the support programme together.
Patient research partners will help design how the outcome of this research will be shared with healthcare professionals and patients. This will include publications, lay summaries shared by patient organisations and presentations at conferences and community events.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study involves a series of focus groups followed by a cross-sectional survey of people with RAIRDs | – | Other: Non-interventional studySystemic lupus erythematosus, systemic vasculitis, inflammatory myositis, systemic sclerosis, Sjogren's syndrome, ANCA-associated vasculitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited via NHS Rheumatology sites, local or national registries, community centres, social media and networks for each focus group in Bristol, Weston and Leeds
Key inclusion criteria (2 listed)
- Diagnosis of a rare rheumatic condition made by hospital doctor or secondary care: including lupus, systemic vasculitis, myositis, Sjogren syndrome (participant self-report)
- Ability to give informed consent (with translation support if needed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Non-interventional studyThe study will consist of focus groups and a large scale patient survey | Other | Study involves a series of focus groups followed by a cross-sectional survey of people with RAIRDs |
Primary outcome
Self-management/efficacy PROM
Time frame: In year 1 during the cross-sectional survey
This study involves qualitative research. The focus group phase will not include outcome measurements. In the cross-sectional survey participants will be asked two questions about self-management and efficacy descriptively to describe the cohort/people who take part
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Results publication: PubMed 34133081Petrocchi V, Visintini E, De Marchi G, Quartuccio L, Palese A. Patient Experiences of Systemic Lupus Erythematosus: Findings From a Systematic Review, Meta-Summary, and Meta-Synthesis. Arthritis Care Res (Hoboken). 2022 Nov;74(11):1813-1821. doi: 10.1002/acr.24639. Epub 2022 Jul 13.
- Results publication: PubMed 17471524Fernandez M, Alarcon GS, Calvo-Alen J, Andrade R, McGwin G Jr, Vila LM, Reveille JD; LUMINA Study Group. A multiethnic, multicenter cohort of patients with systemic lupus erythematosus (SLE) as a model for the study of ethnic disparities in SLE. Arthritis Rheum. 2007 May 15;57(4):576-84. doi: 10.1002/art.22672.
- Results publication: PubMed 16142864Jolly M. How does quality of life of patients with systemic lupus erythematosus compare with that of other common chronic illnesses? J Rheumatol. 2005 Sep;32(9):1706-8.
- Results publication: PubMed 20360188Bowman SJ, St Pierre Y, Sutcliffe N, Isenberg DA, Goldblatt F, Price E, Hamburger J, Richards A, Rauz S, Regan M, Rigby S, Jones A, Mulherin D, Clarke AE. Estimating indirect costs in primary Sjogren's syndrome. J Rheumatol. 2010 May;37(5):1010-5. doi: 10.3899/jrheum.090734. Epub 2010 Apr 1.
- Results publication: PubMed 25479696Quaresma M, Coleman MP, Rachet B. 40-year trends in an index of survival for all cancers combined and survival adjusted for age and sex for each cancer in England and Wales, 1971-2011: a population-based study. Lancet. 2015 Mar 28;385(9974):1206-18. doi: 10.1016/S0140-6736(14)61396-9. Epub 2014 Dec 3.
- Results publication: PubMed 21109517Flossmann O, Berden A, de Groot K, Hagen C, Harper L, Heijl C, Hoglund P, Jayne D, Luqmani R, Mahr A, Mukhtyar C, Pusey C, Rasmussen N, Stegeman C, Walsh M, Westman K; European Vasculitis Study Group. Long-term patient survival in ANCA-associated vasculitis. Ann Rheum Dis. 2011 Mar;70(3):488-94. doi: 10.1136/ard.2010.137778. Epub 2010 Nov 24.
- Results publication: PubMed 16987829Gaubitz M. Epidemiology of connective tissue disorders. Rheumatology (Oxford). 2006 Oct;45 Suppl 3:iii3-4. doi: 10.1093/rheumatology/kel282.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is not an interventional study
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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.
Jen Orme contact
Joanna Robson principal investigator
University of the West of England
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 Lupus Erthematosus and Systemic Vasculitis, run by University of the West of England at 1 site in United Kingdom.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr J Robson (0044117-342-7418, Jo.Robson@uwe.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-management/efficacy PROM (time frame: In year 1 during the cross-sectional survey). 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 NCT06642870, which also lists 7 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 15 Oct 2024.