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)

September 30, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Professor Joanna C Robson, PhD FRCP
  • Phone Number: +44 117 3427418
  • Email: Jo.Robson@uwe.ac.uk

Study Contact Backup

Study Locations

  • United Kingdom
      • Bristol, United Kingdom
        • Focus groups will be held online, no facility will be used

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Each participant will take part in one focus group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of the West of England

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robson, PhD FRCP, University of the West of England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIMS REF 14452364
  • Protocol: IIS-NA-2025-0027 (Other Grant/Funding Number: Vifor Pharma UK Ltd)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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