Rare AutoImmune SElf-management Programme Development

NCT06642870 | Recruiting

• 1 other identifier: IRAS number 336948
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  In year 1 during the cross-sectional survey

Study Arms (1)

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.

Other: Non-interventional study

Interventions

Non-interventional study OTHER

The study will consist of focus groups and a large scale patient survey

Study involves a series of focus groups followed by a cross-sectional survey of people with RAIRDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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)

Sponsors & Collaborators

• University of the West of England: lead
• University of Leeds: collaborator

Study Sites (1)

University of the West of England/ Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

RECRUITING

Related Publications (7)

• 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.

  PMID: 34133081 RESULT

• Fernandez 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.

  PMID: 17471524 RESULT

• Jolly 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.

  PMID: 16142864 RESULT

• Bowman 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.

  PMID: 20360188 RESULT

• Quaresma 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.

  PMID: 25479696 RESULT

• Flossmann 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.

  PMID: 21109517 RESULT

• Gaubitz M. Epidemiology of connective tissue disorders. Rheumatology (Oxford). 2006 Oct;45 Suppl 3:iii3-4. doi: 10.1093/rheumatology/kel282.

  PMID: 16987829 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Systemic Vasculitis; Scleroderma, Systemic; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Skin Diseases, Vascular; Autoimmune Diseases; Immune System Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Joanna Robson

  University of the West of England

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr J Robson

CONTACT

0044117-342-7418; Jo.Robson@uwe.ac.uk

Jen Orme

CONTACT

Jen.Orme@uwe.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)