Cardiovascular Diseases
Conditions
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.
Interventions
DEVICECVD Integrated Risk Test
CVD IRT (Cardiovascular Integrated Risk Tool)
Sponsors
NHS North of England Commissioning Support (NECS)
Genomics PLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Result Return Time | 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) |
| Feasibility: Count of Participants Who Were Successfully Returned a Result | 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) | 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) | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Reclassification Counts | 1.3-8.9 months from baseline (study enrolment) | Count of participants (in the Participants Receiving CVD-IRT arm) up-classified by the CVD-IRT (CVD-IRT≥10%, QRISK®2\<10%) / down-classified by the CVD-IRT (CVD-IRT\<10%, QRISK®2≥10%) / remained high risk (CVD-IRT≥10%, QRISK®2≥10%) / remained low risk (CVD-IRT\<10%, QRISK®2\<10%). |
| CVD-IRT Mean Value | 1.3-8.9 months from baseline (study enrolment) | Mean risk score value (in the Participants Receiving CVD-IRT arm) of the CVD-IRT score |
| HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire) | 1.3-8.9 months from baseline (study enrolment) | Count of Yes responses to the statement If the participant's CVD IRT score was greater than the participant's QRISK2 score, did this influence your management decision? in the HCP post-results questionnaire (separate questionnaire filled at the time each CVD-IRT result was returned to participants) - responses were only recorded if CVD-IRT\> QRISK2 |
| Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire | 1.3-10 months from baseline (study enrolment) | Count of participants responding agree or strongly agree in Likert 5-point response scale (strongly disagree / disagree / neither agree not disagree / agree / strongly agree) to the statement When it comes to the risk of developing heart disease, genetics are as important to measure as factors such as blood pressure in the questionnaire given to participants after receiving their CVD-IRT results |
| Correlation in Saliva-derived and Blood-derived CVD-IRT Scores | End of study (8-10 months after start of study) | Some participants donated a saliva sample in addition to the blood sample (the primary DNA collection method used in this study). At the end of the study, CVD-IRT scores were also calculated from the saliva samples, and these were correlated against the blood-derived CVD-IRT scores |
| 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) | Safety: Count of participants reporting device related adverse events or deficiencies |
| QRISK®2 Mean Value | Within 6 months of study enrolment | Mean risk score value (in the Participants Receiving CVD-IRT arm) of the QRISK®2 score |
Countries
United Kingdom
Participant flow
Recruitment details
The study enrolled 836 participants from 12 sites, of which 832 participated in the analyses by providing blood samples and answering questionnaires. Of these participants 21 took part in the telephone interview. 23 HCPs took part in the final questionnaire, 12 HCPs took part in focus groups and 1 HCP completed an interview. Two PCCs took part in a focus group and 1 PCC completed an interview.
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving CVD-IRT Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study. | 836 |
| Total | 836 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 0 | 0 |
| Overall Study | Protocol Violation | 4 | 0 | 0 |
| Overall Study | Results voided after publishing | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Participants Receiving CVD-IRT |
|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 5.6 |
| Race/Ethnicity, Customized Asian/ Asian British | 11 Participants |
| Race/Ethnicity, Customized Black: Africa/ Black Caribbean/ Black british | 4 Participants |
| Race/Ethnicity, Customized Mixed Multiple | 4 Participants |
| Race/Ethnicity, Customized NA | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 813 Participants |
| Region of Enrollment United Kingdom | 836 participants |
| Sex: Female, Male Female | 518 Participants |
| Sex: Female, Male Male | 318 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 836 |
| other Total, other adverse events | 0 / 836 |
| serious Total, serious adverse events | 0 / 836 |
Outcome results
Primary
Feasibility: Count of Participants Who Were Successfully Returned a Result
Count of non-withdrawn participants (in Participants Receiving CVD-IRT arm) who were successfully returned a CVD-IRT result
Time frame: 1.3-8.9 months from baseline (study enrolment)
Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving CVD-IRT | Feasibility: Count of Participants Who Were Successfully Returned a Result | 832 Participants |
Primary
Feasibility: Result Return Time
Time (in days) between study enrolment and receiving a CVD-IRT result (for participants in Participants Receiving CVD-IRT arm)
Time frame: 1.3-8.9 months from baseline (study enrolment)
Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Receiving CVD-IRT | Feasibility: Result Return Time | 60 days |
Primary
HCP Perception: Count of Favourable Ease-of-use Responses (Post-results Questionnaire)
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)
Time frame: 1.3-8.9 months from baseline (study enrolment)
Population: HCPs who delivered CVD-IRT information to participants as part of this study. A separate questionnaire was filled in every time a CVD-IRT result was returned.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Participants Receiving CVD-IRT | HCP Perception: Count of Favourable Ease-of-use Responses (Post-results Questionnaire) | 747 CVD-IRT results returned |
Primary
HCP Perception: Count of HCPs Recommending Test (End-of-study Questionnaire)
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.
Time frame: End of study (8-10 months after start of study)
Population: HCPs who delivered CVD-IRT information to participants as part of this study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving CVD-IRT | HCP Perception: Count of HCPs Recommending Test (End-of-study Questionnaire) | 17 Participants |
Primary
Participant Satisfaction: Count of Participants Recommending Test in Post-results Questionnaire
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
Time frame: 1.3-10 months from baseline (study enrolment)
Population: 520 participants responded after they received their CVD-IRT result, through an on-line survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving CVD-IRT | Participant Satisfaction: Count of Participants Recommending Test in Post-results Questionnaire | 452 Participants |
Primary
Participant Satisfaction: Count of Participants Who Found Test Easy to Understand in Post-results Questionnaire
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
Time frame: 1.3-10 months from baseline (study enrolment)
Population: 520 participants responded after they received their CVD-IRT result, through an on-line survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving CVD-IRT | Participant Satisfaction: Count of Participants Who Found Test Easy to Understand in Post-results Questionnaire | 492 Participants |
Primary
Participant Satisfaction: Count of Participants Who Found Test Useful in Post-results Questionnaire
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
Time frame: 1.3-10 months from baseline (study enrolment)
Population: 520 participants responded after they received their CVD-IRT result, through an on-line survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving CVD-IRT | Participant Satisfaction: Count of Participants Who Found Test Useful in Post-results Questionnaire | 514 Participants |
Secondary
Correlation in Saliva-derived and Blood-derived CVD-IRT Scores
Some participants donated a saliva sample in addition to the blood sample (the primary DNA collection method used in this study). At the end of the study, CVD-IRT scores were also calculated from the saliva samples, and these were correlated against the blood-derived CVD-IRT scores
Time frame: End of study (8-10 months after start of study)
Population: 91 participants donated a saliva sample in addition to the blood sample which was the primary DNA collection method in this study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Receiving CVD-IRT | Correlation in Saliva-derived and Blood-derived CVD-IRT Scores | 0.999 Pearson correlation coefficient |
Secondary
CVD-IRT Mean Value
Mean risk score value (in the Participants Receiving CVD-IRT arm) of the CVD-IRT score
Time frame: 1.3-8.9 months from baseline (study enrolment)
Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants Receiving CVD-IRT | CVD-IRT Mean Value | 6.6 percentage risk |
Secondary
HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire)
Count of Yes responses to the statement If the participant's CVD IRT score was greater than the participant's QRISK2 score, did this influence your management decision? in the HCP post-results questionnaire (separate questionnaire filled at the time each CVD-IRT result was returned to participants) - responses were only recorded if CVD-IRT\> QRISK2
Time frame: 1.3-8.9 months from baseline (study enrolment)
Population: HCPs who delivered CVD-IRT information to participants as part of this study. A separate questionnaire was filled in every time a CVD-IRT result was returned. This question was only posed if CVD-IRT\<QRISK2, a condition which was met for 388 results.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Participants Receiving CVD-IRT | HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire) | 108 CVD-IRT>QRISK2 results |
Secondary
Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire
Count of participants responding agree or strongly agree in Likert 5-point response scale (strongly disagree / disagree / neither agree not disagree / agree / strongly agree) to the statement When it comes to the risk of developing heart disease, genetics are as important to measure as factors such as blood pressure in the questionnaire given to participants after receiving their CVD-IRT results
Time frame: 1.3-10 months from baseline (study enrolment)
Population: 520 participants responded after they received their CVD-IRT result, through an on-line survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving CVD-IRT | Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire | 443 Participants |
Secondary
QRISK®2 Mean Value
Mean risk score value (in the Participants Receiving CVD-IRT arm) of the QRISK®2 score
Time frame: Within 6 months of study enrolment
Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants Receiving CVD-IRT | QRISK®2 Mean Value | 6.4 percentage risk |
Secondary
Risk Reclassification Counts
Count of participants (in the Participants Receiving CVD-IRT arm) up-classified by the CVD-IRT (CVD-IRT≥10%, QRISK®2\<10%) / down-classified by the CVD-IRT (CVD-IRT\<10%, QRISK®2≥10%) / remained high risk (CVD-IRT≥10%, QRISK®2≥10%) / remained low risk (CVD-IRT\<10%, QRISK®2\<10%).
Time frame: 1.3-8.9 months from baseline (study enrolment)
Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Receiving CVD-IRT | Risk Reclassification Counts | Up-classified to high risk (CVD-IRT≥10%, QRISK®2<10%) | 43 Participants |
| Participants Receiving CVD-IRT | Risk Reclassification Counts | Down-classified to low risk (CVD-IRT<10%, QRISK®2≥10%) | 43 Participants |
| Participants Receiving CVD-IRT | Risk Reclassification Counts | Remained high risk for both CVD-IRT and QRISK®2 (≥10%) | 118 Participants |
| Participants Receiving CVD-IRT | Risk Reclassification Counts | Remained low risk for both CVD-IRT and QRISK®2 (<10%) | 628 Participants |
Secondary
Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies
Safety: Count of participants reporting device related adverse events or deficiencies
Time frame: From start of study to end of study (10 months after start of study)
Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Receiving CVD-IRT | Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies | 0 Participants |