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Qualitative Study With Focus Groups of People Living With ANCA-associated Vasculitis (AAV) and Clinicians, to Explore Different Perspectives on Shared Decision-making in AAV. (PACT-AAV)

30 de setembro de 2026 atualizado por: University of the West of England

PACT-AAV Patients and Clinicians Together Shared Decision Making in ANCA Associated Vasculitis

This research aims to underpin qualitative work with people living with a diagnosis of AAV and healthcare professionals working with people living with AAV, to explore different perspectives on Shared Decision Making (SDM) in AAV. The aim is to develop key principles to consider in the future development of shared decision-making tools and interventions for use in clinical practice.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

The ANCA- associated vasculitides (AAVs) are multi-system autoimmune disorders characterised by inflammation of the small blood vessels. This collective term encompasses granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). People living with AAV can have organ and life-threatening disease, and live with a range of impacts on their health-related quality of life. Patients can be cared for across different medical specialities, e.g. nephrology and rheumatology departments. The National UK and Ireland Vasculitis Registry and the patient charities Vasculitis UK, Vasculitis Ireland Awareness and the UK Kidney Association have identified support for patients to help them manage and live well with their diseases as of key importance to people with AAV.

According to NICE, shared decision-making (SDM) should be adopted as an integral part across all healthcare settings for the day-to-day care of patients. It encourages healthcare professionals (HCPs) and people living with AAV to work together in making decisions about their treatment and care. The guidelines produced by NICE, are for HCPs and individuals accessing healthcare services. It includes training recommendations, how to communicate treatment benefits, risks and consequences and includes tools such as patient decisions aids. By embedding SDM into organisational culture and practices, people are empowered to make informed choices about their health based on their personal values and beliefs. SDM should be adopted for both immediate care decisions and those for the future and by empowering a patient with this knowledge, they can make considered decisions about what care they feel is right for them.

The recent EULAR recommendations for management of AAV highlight that SDM should be a key element of care, but at present this has not been implemented in any systematic way. The Outcome Measures in Rheumatology (OMERACT) SDM working group have developed and are trialling a core outcome set of SDM interventions for musculoskeletal and rheumatology health. Working on the basis that clinical trials must measure not only disease specific outcomes but also those of the intervention, OMERACT identified six outcome domains to be evaluated for their effectiveness and safety when used as SDM interventions within rheumatology. These are 1. knowledge of options, 2. alignment of chosen options with values, 3. confidence in the chosen options, 4. satisfaction with the decision-making process, 5. adherence to the chosen option and 6. potential negative consequences.

Recent research has evidenced that poor social determinants of health can impact patients with AAV which contribute as barriers to accessing healthcare. Those from lower socio-economic status can often struggle to attend appointments, which can lead to greater risk of flare-ups and emergency department visits. Regular attendance at specialist healthcare appointments can improve long-term adherence to medication, supporting improvement towards remission and preventing relapses. In AAV, SDM could mean people are supported to understand the care, treatment and support options available, whilst being educated on the risks, benefits and consequences of those options. This information sharing aims to support patients to make an informed decision about a preferred course of action, using evidence-based, good-quality information and their personal preferences. This is one of the aspects we will explore within these focus groups.

Tipo de estudo

Observacional

Inscrição (Estimado)

80

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Professor Joanna C Robson, PhD FRCP
  • Número de telefone: +44 117 3427418
  • E-mail: Jo.Robson@uwe.ac.uk

Estude backup de contato

Locais de estudo

      • Bristol, Reino Unido
        • Focus groups will be held online, no facility will be used

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

People living with AAV will be purposively sampled to include a spectrum of participants with a range of different diseases, stages and demographics (age, gender, geographical location).

Healthcare professionals (HCPs) will be purposively sampled to include a range of different specialities/roles, experience and geographical locations.

Descrição

People living with ANCA-associated vasculitis focus groups:

Inclusion Criteria:

  • People who have a diagnosis of ANCA- associated vasculitides (AAVs)
  • Aged 18 years or older.
  • People should have capacity to give informed consent.
  • People should have a good understanding of spoken and written English to be able to understand the participant information sheets, and consent forms.
  • People who live within the UK or Ireland.

Exclusion Criteria:

  • People who do not have ANCA-associated vasculitis
  • People less than 18 years of age
  • People without capacity to give informed consent
  • People who are not able to take part in the focus group in English
  • People who live outside the UK or Ireland
  • Members of the steering committee

Healthcare Professionals (HCPs) focus groups:

Inclusion Criteria:

  • HCPs can include doctors, specialist nurses, physiotherapists, occupational therapists, psychologists, and pharmacists.
  • HCPs who work with patients with AAV.
  • HCPs working in the UK or Ireland.

Exclusion Criteria:

  • HCPs who do not work with people with AAV
  • HCPs who work outside of the UK or Ireland
  • Member of the steering committee

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: COHORT
  • Perspectivas de Tempo: PROSPECTIVE

Coortes e Intervenções

Grupo / Coorte
Patient focus group

Adults aged 18 years and over who are living with ANCA associated Vasculitis. There will be six patient focus groups be split into two. The first three groups will be asked to think-through and discuss any experience they had of SDM throughout diagnosis and starting treatment. The second three groups will be asked to think -through and discuss any experience they had of SDM during the process of maintenance, managing flares and stopping treatment.

Clinician focus group

There will be two online clinician focus groups. The clinicians will be recruited from a wider range of healthcare professionals (HCPs). These will include doctors, specialist nurses, physiotherapists, occupational therapists, psychologists, and pharmacists. These HCPs will be asked for their perspectives on key principles of shared decision making in ANCA associated vasculitis.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Domains of importance and contextual factors in relation to shared decision making in ANCA-associated vasculitis.
Prazo: Each participant will take part in one focus group

This is a qualitative focus group study with patients living with ANCA-associated vasculitis and their clinicians. No specific quantitative outcome measures will be collected as part of the focus groups. Thematic analysis and Framework analysis will be used to determine themes of importance in relation to optimal shared decision making in terms of timing, disease duration, stage of treatment (induction, remission, maintenance, flare), who should take part in SDM and useful resources or education materials.

Each participant will take part in one focus group

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Robson, PhD FRCP, University of the West of England

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

9 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de setembro de 2026

Primeira postagem (Real)

6 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • PIMS REF 14452364
  • Protocol: IIS-NA-2025-0027 (Número de outro subsídio/financiamento: Vifor Pharma UK Ltd)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

The anonymised dataset may be used for secondary analysis, and this will be included in the wording of all relevant patient documentation to reflect the potential future use of these data in research.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .