ANCA Associated Vasculitis (AAV)PACT-AAVNCT07859995
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.
An observational study of ANCA Associated Vasculitis (AAV), run by University of the West of England at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA Associated Vasculitis (AAV)
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2026to 1 Mar 2027
- 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: 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.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Healthcare Professionals (HCPs) focus groups:
- HCPs who do not work with people with AAV
- HCPs who work outside of the UK or Ireland
- Member of the steering committee
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Focus groups will be held online, no facility will be used
Bristol
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- ANCA Associated Vasculitis (AAV)
- Keywords
- ANCA Associated Vasculitis (AAV), Shared Decision Making, Qualitative, Healthcare professionals, Patients with Vasculitis
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Domains of importance and contextual factors in relation to shared decision making in ANCA-associated vasculitis.
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.
Measured: Each participant will take part in one focus group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ANCA Associated Vasculitis (AAV)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the West of England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robson, PhD FRCP, Principal investigator, University of the West of England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859995
- Sponsor's protocol ID
- PIMS REF 14452364
- Other IDs
- Protocol: IIS-NA-2025-0027
- Acronym
- PACT-AAV
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Morrison T, Foster E, Dougherty J, Barton J. Shared decision making in rheumatology: A scoping review. Semin Arthritis Rheum. 2022 Oct;56:152041. doi: 10.1016/j.semarthrit.2022.152041. Epub 2022 Jun 3.
PubMed 35738040Junek M, Choi S, Qi Y, Al-Magooshi ASA, Guyatt G, Thabane L, Mendel A, Khalidi N, Walsh M. Values, preferences, and informational needs of individuals living with ANCA-associated vasculitis: a systematic review. Rheumatol Adv Pract. 2026 Jun 12;10(3):rkag057. doi: 10.1093/rap/rkag057. eCollection 2026.
PubMed 42306257
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACT-AAV Patients and Clinicians Together Shared Decision Making in ANCA Associated Vasculitis
- ClinicalTrials.gov ID
- NCT07859995
- Acronym / sponsor ID
- PACT-AAV / PIMS REF 14452364
- Conditions
- ANCA Associated Vasculitis (AAV)
- Keywords
- ANCA Associated Vasculitis (AAV), Shared Decision Making, Qualitative, Healthcare professionals, Patients with Vasculitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of the West of EnglandUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 6 Oct 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Domains of importance and contextual factors in relation to shared decision making in ANCA-associated vasculitis.
Time frame: 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.
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 6 Oct 2026.
- Background: PubMed 35738040Morrison T, Foster E, Dougherty J, Barton J. Shared decision making in rheumatology: A scoping review. Semin Arthritis Rheum. 2022 Oct;56:152041. doi: 10.1016/j.semarthrit.2022.152041. Epub 2022 Jun 3.
- Background: PubMed 42306257Junek M, Choi S, Qi Y, Al-Magooshi ASA, Guyatt G, Thabane L, Mendel A, Khalidi N, Walsh M. Values, preferences, and informational needs of individuals living with ANCA-associated vasculitis: a systematic review. Rheumatol Adv Pract. 2026 Jun 12;10(3):rkag057. doi: 10.1093/rap/rkag057. eCollection 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Robson, PhD FRCP 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 ANCA Associated Vasculitis (AAV), 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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 6 Oct 2026. 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 Professor Joanna C Robson, PhD FRCP (+44 117 3427418, 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?
Domains of importance and contextual factors in relation to shared decision making in ANCA-associated vasculitis. (time frame: Each participant will take part in one focus group). 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 NCT07859995, which also lists 2 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 6 Oct 2026.