Clinical trial NCT05294419: The Healthcare Evaluation of Absolute Risk Testing Study
Official title: The Healthcare Evaluation of Absolute Risk Testing Study: A Multi-centre, Single Arm, Pragmatic Study in Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Genomics PLC
Sponsor class: INDUSTRY
Collaborators: name: NHS North of England Commissioning Support (NECS)
First posted: 2022-03-24
Enrollment: 836
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to demonstrate the integration and use of cardiovascular disease (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible.

This study will recruit participants of both biological sexes and any ancestry or background who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study, as they are more likely to be asymptomatic but also derive most benefit from preventative measures.

The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if incorporated into primary care practice for early identification of patients at highest risk.

This study is a device performance evaluation.

Detailed description: The aim of this study is to demonstrate the integration and use of a cardiovascular disease (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible.

In association with the routine healthchecks for CVD, the QRISK score will be integrated with the individuals polygenic risk score (from a blood sample) to produce the CVD IRT score, this score estimates the risk of CVD in the following 10years.

This study will recruit participants of both biological sexes and any ancestry or background who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study, as they are more likely to be asymptomatic but also derive most benefit from preventative measures.

The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if incorporated into primary care practice for early identification of patients at highest risk.

This study is a device performance evaluation. 1000 participants are expected to be enrolled. Of this, it is expected that 200 surveys will be completed and from those surveyed 20-30 interviewed. This would be considered an adequate determination of feasibility.

Eligibility criteria: Inclusion Criteria:

* Able and willing to provide written informed consent and to comply with the study protocol
* Either male or female (biological sex)
* Aged 45-64 years (inclusive)
* Any ancestry or background
* Eligible for NHS Health Check using QRISK®2 assessment

Exclusion Criteria:

* Those excluded from NHS Health Checks;
* Currently prescribed and taking HMG-CoA reductase inhibitors (lipid-lowering preventive treatments or statins) for any indication.

Primary outcomes:
measure: To demonstrate that an IRT (combining genetic and non-genetic risk factors) for CVD can be incorporated into routine primary care.
timeFrame: Participant surveys completed 12-16 weeks after enrolment
measure: To demonstrate that an IRT (combining genetic and non-genetic risk factors) for CVD can be incorporated into routine primary care.
timeFrame: Clinician surveys at the point of reported CVD-IRT (9-12 weeks after participant enrollment )
measure: To demonstrate that an IRT (combining genetic and non-genetic risk factors) for CVD can be incorporated into routine primary care.
timeFrame: Up to 12 weeks after participant enrolment and sample collection at visit 1
Secondary outcomes:
measure: To explore and assess the impact of the CVD IRT on clinical decision-making.
timeFrame: Data collected within 2 weeks of CVD-IRT report (9-12 weeks after participant enrolment)
measure: To assess the magnitude of the change in risk score between QRISK®2 and CVD IRT
timeFrame: CVD IRT report expected 9-12 weeks after visit 1. Analysis will be performed after all samples are analysed by laboratory methods
measure: To explore and assess to what extent HCPs and PCCs perceive the CVD IRT as operationally efficient and enhancing the service that they provide
timeFrame: Data collected within 2 months of last participant CVD-IRT report
measure: To explore and assess to what extent HCPs and PCCs perceive the CVD IRT as clinically relevant
timeFrame: Data collected within 2 months of last participant CVD-IRT report
measure: To explore and assess to what extent participants perceive the information received through the CVD IRT as informative for health and wellness
timeFrame: Data collected within 2 weeks of CVD-IRT report and interview within 2 months of CVD-IRT report
measure: To explore and assess the impact of the CVD IRT on patient engagement
timeFrame: Data collected within 2 weeks of report and interview within 2 months of CVD-IRT report
measure: To identify and explore effective ways to communicate risk and genetics information about CVD IRT to patients, HCP and PCCs
timeFrame: Data collected within 2 weeks of report and interview within 2 months of CVD-IRT report
measure: Comparison between saliva and blood
timeFrame: Samples collected at visit 1 will be analysed through study completion, up to 1 year
measure: Safety of CVD-IRT
timeFrame: Participant visit 1 to last participant interview or withdrawal
Other outcomes:
measure: Usefulness of CVD IRT
timeFrame: HCP questionnaires within 2 months of last participant CVD-IRT reported
measure: Usefulness of CVD IRT
timeFrame: HCP focus groups within 2 months of last participant CVD-IRT reported
measure: Future development of genetic risk tests
timeFrame: PCC focus groups within 2 months of last participant CVD-IRT reported
Locations:
city: Darlington
country: United Kingdom
facility: Carmel Medical Practice
state: Co Durham
Study officials:
affiliation: Carmel Medical Practice
name: A Fuat, Prof
role: PRINCIPAL_INVESTIGATOR
References: