Rare AutoImmune SElf-management Programme Development

Last updated: October 14, 2024
Sponsor: University of the West of England
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myositis

Sjogren's Syndrome

Collagen Vascular Diseases

Treatment

Non-interventional study

Clinical Study ID

NCT06642870
IRAS number 336948
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of a rare rheumatic condition made by hospital doctor or secondary care:including lupus, systemic vasculitis, myositis, Sjogren syndrome (participantself-report)

  2. Ability to give informed consent (with translation support if needed)

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 360
Treatment Group(s): 1
Primary Treatment: Non-interventional study
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • University of the West of England/ Bristol Royal Infirmary

    Bristol, BS2 8HW
    United Kingdom

    Active - Recruiting

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