The Healthcare Evaluation of Absolute Risk Testing Study: A Multi-centre, Single Arm, Pragmatic Study in Primary Care Setting
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Genomics PLC
- Enrollment
- 862
- Locations
- 1
- Primary Endpoint
- Feasibility: Count of Participants Who Were Successfully Returned a Result
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Feasibility: Count of Participants Who Were Successfully Returned a Result
Time Frame: 1.3-8.9 months from baseline (study enrolment)
Count of non-withdrawn participants (in "Participants Receiving CVD-IRT" arm) who were successfully returned a CVD-IRT result
HCP Perception: Count of HCPs Recommending Test (End-of-study Questionnaire)
Time Frame: End of study (8-10 months after start of study)
Count of healthcare professionals responding "likely" or "very likely" in 5-point Likert response scale ("very unlikely" / "unlikely" / "undecided" / "likely" / "very likely") to the question "Would you recommend the test to colleagues in other practices?'" in HCP end-of-study questionnaire.
HCP Perception: Count of Favourable Ease-of-use Responses (Post-results Questionnaire)
Time Frame: 1.3-8.9 months from baseline (study enrolment)
Count of "Yes" responses to the statement "The CVD-IRT can be incorporated into routine primary care in a straightforward manner" in the HCP post-results questionnaire (separate questionnaire filled at the time each CVD-IRT result was returned to participants)
Participant Satisfaction: Count of Participants Recommending Test in Post-results Questionnaire
Time Frame: 1.3-10 months from baseline (study enrolment)
Count of participants responding "likely" or "very likely" in Likert 5-point response scale ("very unlikely" / "unlikely" / "undecided" / "likely" / "very likely") to the question "How likely would you be to recommend the use of this test to friends or family in similar situations?" in the questionnaire given to participants after receiving their CVD-IRT results
Participant Satisfaction: Count of Participants Who Found Test Useful in Post-results Questionnaire
Time Frame: 1.3-10 months from baseline (study enrolment)
Count of participants responding "Yes" to the question "Did you personally find this test useful?" in the questionnaire given to participants after receiving their CVD-IRT results
Participant Satisfaction: Count of Participants Who Found Test Easy to Understand in Post-results Questionnaire
Time Frame: 1.3-10 months from baseline (study enrolment)
Count of participants responding "Yes" to the question "Were the results easy to understand?" in the questionnaire given to participants after receiving their CVD-IRT results
Feasibility: Result Return Time
Time Frame: 1.3-8.9 months from baseline (study enrolment)
Time (in days) between study enrolment and receiving a CVD-IRT result (for participants in "Participants Receiving CVD-IRT" arm)
Secondary Outcomes
- Risk Reclassification Counts(1.3-8.9 months from baseline (study enrolment))
- Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire(1.3-10 months from baseline (study enrolment))
- Correlation in Saliva-derived and Blood-derived CVD-IRT Scores(End of study (8-10 months after start of study))
- CVD-IRT Mean Value(1.3-8.9 months from baseline (study enrolment))
- HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire)(1.3-8.9 months from baseline (study enrolment))
- Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies(From start of study to end of study (10 months after start of study))
- QRISK®2 Mean Value(Within 6 months of study enrolment)