Patient expectations and experiences of current and new gout management
| ISRCTN | ISRCTN14464374 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14464374 |
| IRAS number | 352392 |
| Secondary identifying numbers | AC25083 |
- Submission date
- 06/05/2025
- Registration date
- 27/05/2025
- Last edited
- 27/05/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Medication for long-term prevention of gout is widely available, but research shows that less than 40% of people with gout are on these medications. New strategies for helping manage gout, such as mobile apps and medication reminders, have been trialled in research. This study aims to further understand what people think about gout and its management by interviewing people with lived experience of gout. Furthermore, preliminary remission criteria for gout have been made by doctors, and the research will explore what people with gout think of remission for their condition, and whether this aligns with the criteria made by doctors. People interested in taking part in this study will take part in filling out a baseline questionnaire involving demographics and information about their gout, followed by a qualitative interview involving open discussion about gout, its management and gout remission. The study expects to recruit participants from all over the UK.
Who can participate?
Adult (aged 18 or older) patients with a diagnosis of gout.
What does the study involve?
Participants will receive a participant information sheet, either as a paper copy or in an online format, allowing them time to review the study details and consider their involvement. Before formal enrolment, participants will be asked a series of screening questions to assess eligibility. Those who meet the eligibility criteria will be invited to provide written informed consent, confirming their agreement to participate in the study. Following the provision of informed consent, participants will be contacted to complete a baseline questionnaire at their own pace. This questionnaire collects information on gout history, current gout medications, comorbid conditions, and overall quality of life. These data provide context for subsequent interviews.
Instructions within the questionnaire will guide participants on how to respond. Assistance will be available either in person or via email for those completing the questionnaire online. Upon completion of the baseline questionnaire, participants will be invited to take part in a voluntary, audio-recorded interview. The interview will explore participants’ understanding of gout, its management, and remission. Participants may decline or withdraw from the interview at any time.
Interviews will be scheduled at a time convenient for the participant. For in-person interviews, a private room at the research site will be used, and verbal consent will be reconfirmed before recording. For online interviews, a Microsoft Teams link will be provided via email. The baseline questionnaire is expected to take approximately 20 minutes to complete.
What are the possible benefits and risks of participating?
There are no direct benefits to participants for taking part in this study. However, the findings may contribute to improved understanding and management of gout, potentially benefiting future patients. Reasonable travel expenses incurred for attending the study site will be reimbursed.
There are no anticipated risks or disadvantages associated with participation. Involvement in the study will not affect the healthcare participants receive. Participation will require a time commitment to complete the baseline questionnaire and attend an interview.
Where is the study run from?
The study will run from a single-centre, at one of the University of Edinburgh sites - The Institute of Genetics and Cancer. However, the study is designed to enable participation in the full study online.
When is the study starting and how long is it expected to run for?
March 2025 to April 2026. The study is expected to start recruiting participants in August 2025 and is expected to finish recruiting in March 2026.
Who is funding the study?
The study is sponsored by ACCORD. The Academic and Clinical Central Office for Research and Development (ACCORD) is a partnership between the University of Edinburgh and NHS Lothian Health Board.
Who is the main contact?
Miss Rowan Hart, r.e.hart@sms.ed.ac.uk
Contact information
Public, Principal Investigator
Institute of Genetics and Cancer - The University of Edinburgh, Crewe Road
Edinburgh
EH4 2XU
United Kingdom
 ORCID ID |
0009-0006-3205-3467 |
|---|---|
| Phone | +44 (0)7704284577 |
| r.e.hart@sms.ed.ac.uk |
Scientific
Rheumatic Diseases Unit, Western General Hospital, Crewe Road
Edinburgh
EH4 2XU
United Kingdom
| ORCID ID |
0000-0003-3029-7098 |
|---|---|
| Phone | +44 (0)7944625313 |
| philip.riches@nhs.scot |
Study information
| Study design | Single-centre interventional mixed-methods study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Qualitative research |
| Study setting(s) | Home, Internet/virtual, University/medical school/dental school |
| Study type | Other, Quality of life |
| Participant information sheet | 47288 PECAN PIS and CF v1.0 28Mar25.pdf |
| Scientific title | Patient Expectations and experiences of Current And Novel (PECAN) management of gout: a qualitative study |
| Study acronym | PECAN |
| Study objectives | What are patient perceptions, experiences and expectations of current and novel gout management, in relation to their experiences of gout? |
| Ethics approval(s) |
Submitted 23/05/2025, Wales REC 7 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922 940968; Wales.REC7@wales.nhs.uk), ref: 25/PR/0697 |
| Health condition(s) or problem(s) studied | Adults (aged 18 or older) with gout |
| Intervention | Participants will be recruited in a 1:1 ratio of those using a novel supported self-management (SSM) strategy for gout, and those who are not. People who are using a SSM will be recruited from an adjacent clinical trial (Clinicaltrials.gov identifier NCT05507723). Participants taking part in this study will fill in a short baseline questionnaire that asks for details about their gout and any gout medication. Further questions include what other medical conditions participants have, and questions about quality of life. After this, participants will take part in one recorded interview which will ask them more in-depth about experiences and expectations of current and novel management for gout, as well as questions about gout remission. Those in the SSM arm will be asked specific questions around the intervention, whereas the other arm will be asked hypothetical questions about using this intervention. All other questions will be the same between the two arms. A thematic analysis of transcripts from the interviews will be undertaken, using a grounded theory approach. Participants in the SSM arm will need to have experienced the intervention for at least one month prior to interview. |
| Intervention type | Other |
| Primary outcome measure | Patient experiences and expectations of current and novel gout management using qualitative interviews analysed using a grounded theory approach |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 28/03/2025 |
| Completion date | 01/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20-30 |
| Key inclusion criteria | 1. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all aspects of the study. 2. Adult aged ≥18 years with gout based on full ACR/EULAR gout classification criteria, those with a physician diagnosis of gout, or those with a likely diagnosis of gout based on symptom questions from ACR/EULAR gout classification criteria. |
| Key exclusion criteria | 1. Participant is unable to consent 2. Participant has limited English language capabilities |
| Date of first enrolment | 01/08/2025 |
| Date of final enrolment | 01/03/2026 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
Sponsor information
Research organisation
Usher Building, The University of Edinburgh, 5-7 Little France Road
Edinburgh BioQuarter- Gate 3
Edinburgh
EH16 4UX
Scotland
United Kingdom
| Phone | +44 (0)131 242 9139 |
|---|---|
| resgov@accord.scot | |
| Website | http://accord.scot/ |
"ROR" |
https://ror.org/01x6s1m65 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of results in a peer-reviewed journal, in presentations at conferences, and as part of a doctoral thesis |
| IPD sharing plan | The transcripts generated during the study are not expected to be made available. Though full transcripts will be pseudonymised and identifiable information generalised, the potential depth and detail of qualitative interview transcripts may have enough information to identify others, even with changed names or places. Furthermore triangulation of data between questionnaire and interview data may increase the likelihood of data being identifiable. The questionnaire data generated during the study will be made available upon request from the chief investigator of the study, Rowan Hart (r.e.hart@sms.ed.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 28/03/2025 | 20/05/2025 | No | Yes |
| Protocol file | version 1.0 | 28/03/2025 | 20/05/2025 | No | No |
Additional files
Editorial Notes
27/05/2025: Trial's existence confirmed by Wales REC 7.
