Cardiovascular Diseases, Diabetes Mellitus, Type 2, Dyslipidemia, Hypercholesterolemia, Hypertensive Disease
Conditions
Keywords
Vascular screening, Cardiovascular risk factors, Blood pressure, Lipids, Lifestyle, Identifying unknown risk, Low socioeconomic status, low threshold
Brief summary
The overall goal of the present project is to contribute to new knowledge about the effect of a low threshold population screening system for cardiovascular risk factors in Norway. Further, this project aim to study if identifying high cardiovascular risk itself may lead to beneficial changes in health behaviors such as physical activity, diet, tobacco and alcohol behavior together with reduced risk score of cardiovascular disease, across socioeconomic status. This fall, a nationwide, free screening of cardiovascular risk factors will be conducted in 150 pharmacies in Norway. All participants that consent to participate will measure full lipid-profile, blood pressure, HbA1c, body weight and height by health care providers in pharmacies. Based on their measurement levels, participants will be stratified into either a low or a high risk group. In the high risk group, participants will further be randomized to either the intervention group or one of the two control groups. Participants in the intervention group will be informed about all their measurement levels with comparison to the recommended levels. Contrary, participants randomized to the two control groups will have delayed information of their measured levels. Participants in the intervention group and the first control groups will receive general oral and written information about how to lower their measurement levels in 8 weeks. In the second control group, participants will not receive any information at the first visit. In this way the investigators may be able to isolate the effect of identifying high risk and high levels of the risk factors itself. All groups will be given a diet- and physical activity questionnaire at visit 1, and will be invited back after 8 weeks to once more perform the measurement screening and receive the same questionnaire. At visit 2, all participants will, after the measurement screening, be informed about their measured risk factors and receive information on how to lower their levels. 1 year after inclusion, all participants in the three groups will be invited back for a one-year follow up visit in pharmacy.
Detailed description
One year after inclusion, all participants that were not loss to follow up, or had their consent withdrawn, were invited back to pharmacies to perform the same measurements for the third time. However, at this third visit, pharmacies were randomized 1:2 to test an additional intervention. Further, an extra blood sample, dried blood spot, was taken to measure cholesterol, HbA1c and fatty acids. About half of the pharmacies (n=23) communicated cardiovasular disease (CVD) risk factor levels as Heart age compared to own age (British communication tool) together with tailored lifestyle advices on how to reduce elevated levels. While the other 25 pharmacies communicated CVD risk the usual way and gave general lifestyle advices on how to reduce CVD risk. 4 weeks later, all participants took dried blood spot samples at home. We will compare results from dried blood spot samples to study whether heart age and tailored lifestyle advice is more effective than general information in reducing CVD risk. The investigators will also record social security number to make connection to central health registry as prescription registry, patient registry and cause of death registry after 2 years and 5 years.
Interventions
This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks
In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks
In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
Sponsors
Study design
Eligibility
Inclusion criteria
* Above18 years * Not pregnant or lactating * Not previous cardiovascular events nor treatment related to cardiovascular disease ((myocardial infarction, stroke, angina pectoris, coronary artery bypass, - Percutaneous coronary intervention, diabetes type 1 and 2) * No use of cholesterol lowering medication, bloodpressure lowering medication, bloodsugar lowering medication or medication related to diabetes
Exclusion criteria
* Below18 years * Pregnant or lactating * Previous cardiovascular events nor treatment related to cardiovascular disease (myocardial infarction, stroke, angina pectoris, coronary artery bypass, * Percutaneous coronary intervention, diabetes type 1 and 2) * Use of cholesterol lowering medication, bloodpressure lowering medication, bloodsugar lowering medication or medication related to diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14) | Baseline and at 8 weeks | The (ad hoc) risk score was a summarization of points ranging from 0 (favorable measures) , 2 (slighly unfavourable) or 4 (very unfavorable measures) assigned for each of Total cholesterol, HDL-cholesterol, HbA1c, blood pressure, body mass index and age (age was included because presence of elevated cardiovascular disease risk factors is more alarming in younger age). Risk points for each risk factor was summarized into an total risk score ranging from 4 (min) to 14 (max). A total risk score of ≥4 served as inclusion criteria because it indicated moderately elevated risk of cardiovascular disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 8-week Change in Total Cholesterol | At baseline and at 8 weeks | Change in total cholesterol, from date of randomization and until the end of the follow up after 8 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of Heart Age and Tailord CVD Advice After 1 Year | 4 weeks | Comparing results from blood samples after 4 weeks in 23 pharmacies (enhanced CVD communication) versus 25 pharmacies (general communication of CVD risk).N |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Information on High Risk Factor Levels But Lifestyle Advice This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks | 185 |
| No Information on High Risk Factor Levels Nor Lifestyle Advice In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels. | 199 |
| Information on High Risk Factor Levels and Lifestyle Advice This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks | 198 |
| Total | 582 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 1 | 2 |
| Overall Study | Moved/studycenter unable to participate | 4 | 6 | 8 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 3 |
Baseline characteristics
| Characteristic | Total | Information on High Risk Factor Levels and Lifestyle Advice | No Information on High Risk Factor Levels Nor Lifestyle Advice | No Information on High Risk Factor Levels But Lifestyle Advice |
|---|---|---|---|---|
| Ad hoc risk score | 5.3 units on a scale STANDARD_DEVIATION 1.4 | 5.4 units on a scale STANDARD_DEVIATION 1.5 | 5.4 units on a scale STANDARD_DEVIATION 1.5 | 5.2 units on a scale STANDARD_DEVIATION 1.3 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 214 Participants | 67 Participants | 75 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 368 Participants | 131 Participants | 124 Participants | 113 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 14.7 | 55.7 years STANDARD_DEVIATION 14.4 | 56.5 years STANDARD_DEVIATION 15.5 | 57.4 years STANDARD_DEVIATION 14.6 |
| Region of Enrollment Norway | 582 participants | 198 participants | 199 participants | 185 participants |
| Sex: Female, Male Female | 417 Participants | 141 Participants | 136 Participants | 140 Participants |
| Sex: Female, Male Male | 165 Participants | 57 Participants | 63 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 185 | 0 / 199 | 0 / 198 |
| other Total, other adverse events | 0 / 185 | 0 / 199 | 0 / 198 |
| serious Total, serious adverse events | 0 / 185 | 0 / 199 | 0 / 198 |
Outcome results
Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)
The (ad hoc) risk score was a summarization of points ranging from 0 (favorable measures) , 2 (slighly unfavourable) or 4 (very unfavorable measures) assigned for each of Total cholesterol, HDL-cholesterol, HbA1c, blood pressure, body mass index and age (age was included because presence of elevated cardiovascular disease risk factors is more alarming in younger age). Risk points for each risk factor was summarized into an total risk score ranging from 4 (min) to 14 (max). A total risk score of ≥4 served as inclusion criteria because it indicated moderately elevated risk of cardiovascular disease.
Time frame: Baseline and at 8 weeks
Population: Between groups analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Information on High Risk Factor Levels But Lifestyle Advice | Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14) | -0.71 units on a scale |
| No Information on High Risk Factor Levels Nor Lifestyle Advice | Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14) | -0.76 units on a scale |
| Information on High Risk Factor Levels and Lifestyle Advice | Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14) | -0.36 units on a scale |
8-week Change in Total Cholesterol
Change in total cholesterol, from date of randomization and until the end of the follow up after 8 weeks.
Time frame: At baseline and at 8 weeks
Population: Difference between three groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Information on High Risk Factor Levels But Lifestyle Advice | 8-week Change in Total Cholesterol | -0.12 mmol/L |
| No Information on High Risk Factor Levels Nor Lifestyle Advice | 8-week Change in Total Cholesterol | -0.16 mmol/L |
| Information on High Risk Factor Levels and Lifestyle Advice | 8-week Change in Total Cholesterol | -0.08 mmol/L |
Effect of Heart Age and Tailord CVD Advice After 1 Year
Comparing results from blood samples after 4 weeks in 23 pharmacies (enhanced CVD communication) versus 25 pharmacies (general communication of CVD risk).N
Time frame: 4 weeks