An observational study in Systemic Lupus Erthematosus, Systemic Vasculitis and Inflammatory Myositis, sponsored by University of the West of England. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by University of the West of England · Observational
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.
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.
157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.
This study's planned enrollment of 360 is above the median of 120 across 35 observational studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →University of the West of England is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
Compared within Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Systemic Vasculitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Systemic lupus erythematosus, systemic vasculitis, inflammatory myositis, systemic sclerosis, Sjogren's syndrome, ANCA-associated vasculitis.
Other: Non-interventional study
The study will consist of focus groups and a large scale patient survey
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
Time frame: In year 1 during the cross-sectional survey
Plan to share: No — This is not an interventional study
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis →
University of the West of England