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Vascular Lifestyle-Intervention and Screening in Pharmacy

Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02223793
Acronym
VISA
Enrollment
582
Registered
2014-08-22
Start date
2014-09-30
Completion date
2022-02-28
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Diabetes Mellitus, Type 2, Dyslipidemia, Hypercholesterolemia, Hypertensive Disease

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

BEHAVIORALInformation 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

BEHAVIORALNo 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

BEHAVIORALNo 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.

Sponsors

University of Tromso
CollaboratorOTHER
University of Minnesota
CollaboratorOTHER
Boots Norway AS
CollaboratorUNKNOWN
Mills DA
CollaboratorINDUSTRY
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)Baseline and at 8 weeksThe (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

MeasureTime frameDescription
8-week Change in Total CholesterolAt baseline and at 8 weeksChange in total cholesterol, from date of randomization and until the end of the follow up after 8 weeks.

Other

MeasureTime frameDescription
Effect of Heart Age and Tailord CVD Advice After 1 Year4 weeksComparing 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

ArmCount
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
Total582

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up1012
Overall StudyMoved/studycenter unable to participate468
Overall StudyWithdrawal by Subject323

Baseline characteristics

CharacteristicTotalInformation on High Risk Factor Levels and Lifestyle AdviceNo Information on High Risk Factor Levels Nor Lifestyle AdviceNo Information on High Risk Factor Levels But Lifestyle Advice
Ad hoc risk score5.3 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 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
214 Participants67 Participants75 Participants72 Participants
Age, Categorical
Between 18 and 65 years
368 Participants131 Participants124 Participants113 Participants
Age, Continuous56.5 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 participants198 participants199 participants185 participants
Sex: Female, Male
Female
417 Participants141 Participants136 Participants140 Participants
Sex: Female, Male
Male
165 Participants57 Participants63 Participants45 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1850 / 1990 / 198
other
Total, other adverse events
0 / 1850 / 1990 / 198
serious
Total, serious adverse events
0 / 1850 / 1990 / 198

Outcome results

Primary

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

ArmMeasureValue (MEAN)
No Information on High Risk Factor Levels But Lifestyle AdviceChange 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 AdviceChange 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 AdviceChange in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)-0.36 units on a scale
Secondary

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.

ArmMeasureValue (MEAN)
No Information on High Risk Factor Levels But Lifestyle Advice8-week Change in Total Cholesterol-0.12 mmol/L
No Information on High Risk Factor Levels Nor Lifestyle Advice8-week Change in Total Cholesterol-0.16 mmol/L
Information on High Risk Factor Levels and Lifestyle Advice8-week Change in Total Cholesterol-0.08 mmol/L
Other Pre-specified

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

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026