Introducing a home-based genomic risk test to screening pathways for abdominal aortic aneurysms
| ISRCTN | ISRCTN10623216 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10623216 |
| IRAS number | 357437 |
| Secondary identifying numbers | 179223, Wellcome Trust funding Reference number 337446/Z/25/Z |
- Submission date
- 24/09/2025
- Registration date
- 21/10/2025
- Last edited
- 20/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The abdominal aortic aneurysm (AAA) NHS screening programme invites men aged 65 to attend a local clinic for an ultrasound scan to check them for an AAA. One of the things that can increase the risk of someone having an AAA is their genetics. This study will talk to men aged 60-70 to find out what they think about adding a simple home-based spit test to assess their genetic risk for AAA. This will become part of the NHS AAA screening pathway, and their opinions will be sought on communication strategies about sharing this risk.
This study involves two stages: the first being an online interview to help understand how acceptable the inclusion of genetic assessments in the AAA screening might be, and how people should be informed about their personal genetic risk of AAA, if this were to be introduced. The second stage is helping design the documents to communicate this in the future. Taking part in this research study could potentially benefit others by providing more robust research on patients’ perspectives on providing a more personalised approach to AAA screening and the best methods of communication for this approach to patients. It is hoped that this will encourage those patients most at risk of developing an AAA to attend screening appointments in the future.
Who can participate?
Healthy volunteer men who are 60 to 70 years old
What does the study involve?
Participants who choose to take part in this part of the research will be invited to a one-off interview to share their views on the potential use of genetic risk assessments in the pathways and invitations for AAA screening. The interview will last approximately 45–60 minutes and will be audio recorded.
Interviews will be conducted online via Microsoft Teams at a time and date that suits the participant. If preferred, an in-person interview can be arranged at the University of Leicester. In such cases, travel and parking expenses will be reimbursed upon receipt of valid proof of payment.
Before the interview, a phone call will be arranged to explain the study in more detail, answer any questions, and confirm the participant’s eligibility. Participants in this part of the study will also have the opportunity to take part in a second stage (work package 2), which involves helping to develop documents and a decision support tool to improve how screening invitations are communicated to the public. This is entirely optional. Those interested can indicate this on the consent form and will be contacted later with more information. A separate consent form will be required for participation in work package 2. Expressing interest at this stage does not commit participants to taking part.
What are the possible benefits and risks of participating?
Taking part in this research study could potentially benefit others by providing more robust research on patients’ perspectives on providing a more personalised approach to AAA screening and the best methods of communication for this approach to patients. It is hoped that this will encourage those patients most at risk of developing an AAA to attend screening appointments in the future. There are no direct risks or side effects to taking part, but understand that a 45-60 minute time commitment for the interview, plus the earlier eligibility call, may be inconvenient.
Where is the study run from?
The University of Leicester, UK
When is the study starting and how long is it expected to run for?
January 2025 to October 2026
Who is funding the study?
The Wellcome Trust, UK
Who is the main contact?
Chloe Norman, cgn9@leicester.ac.uk
Contact information
Public, Scientific
University of Leicester
University Road
Leicester
LE3 9QP
United Kingdom
 ORCID ID |
0000-0002-3275-3141 |
|---|---|
| Phone | +44 (0)7722192848 |
| cgn9@leicester.ac.uk |
Principal Investigator
University of Leicester
University Road
Leicester
LE3 9QP
United Kingdom
| Phone | +44 (0)116 252 3190 |
|---|---|
| m.bown@le.ac.uk |
Study information
| Study design | Single-centre qualitative cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community, Internet/virtual, Telephone, University/medical school/dental school |
| Study type | Other, Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Genomic risk assessment in screening pathways for abdominal aortic aneurysms |
| Study acronym | GRASP |
| Study objectives | To determine the public acceptability, perception and preferences for introducing genomic risk assessment into AAA screening pathways |
| Ethics approval(s) |
Approved 29/07/2025, South Central - Hampshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8088; hampshireb.rec@hra.nhs.uk), ref: 25/SC/0243 |
| Health condition(s) or problem(s) studied | Abdominal aortic aneurysm population screening |
| Intervention | This study is a qualitative study split into two distinct work packages. All packages are to be undertaken in the community, coordinated by the University of Leicester. GPs in Leicestershire will be used as a Participant Identification Centre (PIC) site to identify participants to invite, and adverts on social media will offer opportunities for nationwide participation. This project is taking place in Leicestershire, which offers a diverse population in both ethnicity and socio-demographic status, and the population in Leicester city and the surrounding areas of the county are very different. Therefore, a purposive sampling approach through a geographical area has been selected to ensure the best representation of the research topic and help generate rich data. It is estimated that a sample of around 20-25 participants will ensure a representative sample of the population, but recruitment and interviews will continue until thematic saturation and information power across multiple ethnic groups. The research team will also be using adverts on social media to invite men nationally to express interest in participating. Expression of interest can be made through an online form, email or phone. Initial recruitment will begin in work package one, and participants will be invited to take part as described above. Following a participant’s expression of interest, an eligibility call will be arranged to provide further information about the study and to check their suitability to take part in the study. A pre-screening eligibility check will be conducted via telephone to check the following eligibility criteria: - Men aged 60 – 70 years - Able to provide informed consent - Speak and understand the English language Where pre-screening eligibility is confirmed, the participant will be invited to continue with the study. Work Package One Once consent has been obtained, participants partaking in WP1 will take part in a semi-structured interview lasting 45- 60 minutes conducted by a researcher at a pre-arranged, convenient time. Participants will primarily undertake remote interviews conducted via Microsoft Teams; however, the option of face-to-face interviews will be offered on an ad hoc basis if required. Where face-to-face interviews occur, these will take place in approved University of Leicester spaces such as George Davies Centre Rooms 1.07 or 1.21 and will follow Sponsor guidelines with considerations to any specific requirements the participants may have. Participants will be able to take breaks if required and can choose to end the interview at any time. The interviews will be offered initially via MS Teams, but alternative methods can be offered to provide flexibility and ease of access to participants to best suit their needs. A semi-structured interview guide has been developed around topic themes generated from existing literature, but this is flexible to ensure other unanticipated themes can emerge. Demographic data, including age, ethnicity, and previous experience with AAA screening appointments, will also be obtained during the interviews to provide context during analysis. Reflexive thematic analysis will be used to analyse transcribed interviews in WP1 to identify themes and the depth of understanding. This will be done using the 6-step approach to thematic analysis outlined by Braun and Clarke to include familiarisation, coding, theme development, refinement, defining and naming and producing a report. The documents and details for WP2 will be added via an amendment once the data has been collected and analysed. Work Package 2 WP2 is a six-step co-design process based on other previous studies designing and improving documentation for patients, including the CanRisk model for cancer screening, to ensure active collaboration and input from the public when creating a process being designed for them. Separate information sheets will be provided for WP2, and separate consent will be taken. Following the completion of WP1, examples of potential document packs will be created using the outcomes of WP1 alongside a web-based decision support tool to aid understanding. These will then be used for think-aloud testing with participants, which will be video or audio-recorded and transcribed verbatim in the same method as above. A round of structured feedback will follow to update the documents and decision support tool, which will then have a second round of structured feedback before finalisation. Due to the nature of WP2 requiring input from the findings of WP1, the documents for WP2 will be created in due course and will be submitted for regulatory approval via an amendment. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Public perception and trust of using genomic risk and lifestyle factors as part of an enhanced AAA screening invitation will be measured using data collected during semi-structured interviews in WP1 at a one-off interview following consent 2. Appropriate and publicly acceptable methods for the communication of genomic risk during WP2 will be measured using data collected and documents co-produced during think-aloud testing in WP2 at a focus group and 2 points of structured feedback |
| Secondary outcome measures | W1: 1. Public understanding of genomic risk will be measured using data collected during semi-structured interviews in WP1 at a one-off interview following consent 2. Public perception and trust in using genomic risk and lifestyle factors will be measured using data collected during semi-structured interviews in WP1 at a one-off interview following consent 3. Preferences for communication of genomic and lifestyle risk information will be measured using data collected during semi-structured interviews in WP1 at a one-off interview following consent W2: 4. Design of an online decision support tool will be measured using data collected and documents co-produced during think-aloud testing in WP2 at a focus group, and 2 points of structured feedback |
| Overall study start date | 01/01/2025 |
| Completion date | 20/10/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Upper age limit | 70 Years |
| Sex | Male |
| Target number of participants | 25 |
| Key inclusion criteria | 1. Men aged 60 – 70 years 2. Able to provide informed consent 3. Speak and understand the English language |
| Key exclusion criteria | Unable to speak or understand the English language |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 01/10/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester
LE1 7RH
United Kingdom
Sponsor information
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 (0)116 3736508 |
|---|---|
| rgosponsor@le.ac.uk | |
| Website | https://le.ac.uk |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Research council
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Wellcome, WT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authorship will be determined in accordance with the ICMJE guidelines, and other contributors will be acknowledged. Research participants will have the opportunity to receive a summary of the study findings. If they wish to receive a copy, this will be indicated on their consent form. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 22/07/2025 | 03/10/2025 | No | No |
Additional files
Editorial Notes
25/09/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
