The Healthcare Evaluation of Absolute Risk Testing Study
- Conditions
- Cardiovascular Diseases
- Registration Number
- NCT05294419
- Lead Sponsor
- Genomics PLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 836
- 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
- Those excluded from NHS Health Checks;
- Currently prescribed and taking HMG-CoA reductase inhibitors (lipid-lowering preventive treatments or statins) for any indication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To demonstrate that an IRT (combining genetic and non-genetic risk factors) for CVD can be incorporated into routine primary care. Up to 12 weeks after participant enrolment and sample collection at visit 1 Descriptive analysis of report rate
- Secondary Outcome Measures
Name Time Method To explore and assess the impact of the CVD IRT on clinical decision-making. Data collected within 2 weeks of CVD-IRT report (9-12 weeks after participant enrolment) Descriptive analysis of Clinician surveys completed at the time of CVD-IRT report to indicate the potential influence the CVD-IRT score would make to the current clinical treatment practice.
To assess the magnitude of the change in risk score between QRISK®2 and CVD IRT CVD IRT report expected 9-12 weeks after visit 1. Analysis will be performed after all samples are analysed by laboratory methods Analysis of the difference between the QRISK and CVD -IRT scores in the cohort for participants who have increased or decreased risk due to the introduction of a polygenic risk score and present this data
To explore and assess to what extent HCPs and PCCs perceive the CVD IRT as clinically relevant Data collected within 2 months of last participant CVD-IRT report Descriptive analysis of Clinician and PCC (primary care commissioning groups) as interviews completed at the end of participant participation
To explore and assess to what extent participants perceive the information received through the CVD IRT as informative for health and wellness Data collected within 2 weeks of CVD-IRT report and interview within 2 months of CVD-IRT report Descriptive analysis of Participant interviews completed at the end of participant participation
To identify and explore effective ways to communicate risk and genetics information about CVD IRT to patients, HCP and PCCs Data collected within 2 weeks of report and interview within 2 months of CVD-IRT report Descriptive analysis of Participant, HCP and PCC interviews completed at the end of participant participation
Comparison between saliva and blood Samples collected at visit 1 will be analysed through study completion, up to 1 year Analysis of saliva as compared to blood CVD-IRT results as analysed by laboratory methods
Safety of CVD-IRT Participant visit 1 to last participant interview or withdrawal Reporting of AE and device related deficiencies
To explore and assess to what extent HCPs and PCCs perceive the CVD IRT as operationally efficient and enhancing the service that they provide Data collected within 2 months of last participant CVD-IRT report Descriptive analysis of Clinician and PCC (primary care commissioning groups) interviews completed at the end of participant participation
To explore and assess the impact of the CVD IRT on patient engagement Data collected within 2 weeks of report and interview within 2 months of CVD-IRT report Descriptive analysis of Participant interviews completed at the end of participant participation
Trial Locations
- Locations (1)
Carmel Medical Practice
🇬🇧Darlington, Co Durham, United Kingdom
Carmel Medical Practice🇬🇧Darlington, Co Durham, United Kingdom