Cardiovascular DiseasesVISANCT02223793
Vascular Lifestyle-Intervention and Screening in Pharmacy
A study testing Information on high risk factor levels and lifestyle advice, No information on high risk factor levels but lifestyle advice and No information on high risk factor levels, nor lifestyle advice in people with Cardiovascular Diseases and Hypercholesterolemia, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypercholesterolemia, Dyslipidemia
- What is being tested?
- Information on high risk factor levels and lifestyle advice, No information on high risk factor levels but lifestyle advice and No information on high risk factor levels, nor lifestyle advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2014to Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Hypercholesterolemia, Dyslipidemia, Hypertensive Disease, Diabetes Mellitus, Type 2
- Being tested
- Information on high risk factor levels and lifestyle advice, No information on high risk factor levels but lifestyle advice, No information on high risk factor levels, nor lifestyle advice
- Keywords
- Vascular screening, Cardiovascular risk factors, Blood pressure, Lipids, Lifestyle, Identifying unknown risk, Low socioeconomic status, low threshold
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia, Dyslipidemias, Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information on high risk factor levels and lifestyle adviceBehavioural
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
No information on high risk factor levels but lifestyle adviceBehavioural
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
No information on high risk factor levels, nor lifestyle adviceBehavioural
In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
| Study group | Role | What they receive |
|---|---|---|
| No information on high risk factor levels but lifestyle advice | Experimental | 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 Receives: Behavioral: No information on high risk factor levels but lifestyle advice |
| No information on high risk factor levels nor lifestyle advice | Experimental | In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline Receives: Behavioral: No information on high risk factor levels, nor lifestyle advice |
| Information on high risk factor levels and lifestyle advice | Experimental | 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 Receives: Behavioral: Information on high risk factor levels and lifestyle advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 8 weeks
Secondary outcomes (1)
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.
Measured: At baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, University of Minnesota, Boots Norway AS, Mills DA
- Responsible party
- Principal investigator, Karianne Svendsen, University of Oslo
- Investigators
- Karianne Svendsen, M.Sc., Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223793
- Sponsor's protocol ID
- 2013/1660
- Other IDs
- 39255 (NSD), 1660/2013
- Acronym
- VISA
- Status last verified
- Apr 2020
- First submitted
- 18 Aug 2014
- Last updated
- 6 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Svendsen K, Telle-Hansen VH, Morch-Reiersen LT, Garstad KW, Thyholt K, Granlund L, Henriksen HB, Gran JM, Jacobs DR Jr, Retterstol K. A randomized controlled trial in Norwegian pharmacies on effects of risk alert and advice in people with elevated cardiovascular risk. Prev Med Rep. 2018 Aug 9;12:79-86. doi: 10.1016/j.pmedr.2018.08.004. eCollection 2018 Dec.
PubMed 30191097
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study
- ClinicalTrials.gov ID
- NCT02223793
- Acronym / sponsor ID
- VISA / 2013/1660
- Conditions
- Cardiovascular Diseases, Hypercholesterolemia, Dyslipidemia, Hypertensive Disease, Diabetes Mellitus, Type 2
- Keywords
- Vascular screening, Cardiovascular risk factors, Blood pressure, Lipids, Lifestyle, Identifying unknown risk, Low socioeconomic status, low threshold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 582 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- University of Tromso, University of Minnesota, Boots Norway AS, Mills DA
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2022 (estimated)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No information on high risk factor levels but lifestyle advice | Experimental | Behavioral: No information on high risk factor levels but lifestyle adviceThis 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 nor lifestyle advice | Experimental | Behavioral: No information on high risk factor levels, nor lifestyle adviceIn this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline |
| Information on high risk factor levels and lifestyle advice | Experimental | Behavioral: Information on high risk factor levels and lifestyle adviceThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information on high risk factor levels and lifestyle adviceThis 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 | Behavioural | Information on high risk factor levels and lifestyle advice |
| No information on high risk factor levels but lifestyle adviceIn 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 | Behavioural | No information on high risk factor levels but lifestyle advice |
| No information on high risk factor levels, nor lifestyle adviceIn this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels. | Behavioural | No information on high risk factor levels nor lifestyle advice |
Primary outcome
Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)
Time frame: 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.
1 secondary outcome
8-week Change in Total Cholesterol
Time frame: At baseline and at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30191097Svendsen K, Telle-Hansen VH, Morch-Reiersen LT, Garstad KW, Thyholt K, Granlund L, Henriksen HB, Gran JM, Jacobs DR Jr, Retterstol K. A randomized controlled trial in Norwegian pharmacies on effects of risk alert and advice in people with elevated cardiovascular risk. Prev Med Rep. 2018 Aug 9;12:79-86. doi: 10.1016/j.pmedr.2018.08.004. eCollection 2018 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karianne Svendsen, M.Sc. principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information on high risk factor levels and lifestyle advice, No information on high risk factor levels but lifestyle advice and No information on high risk factor levels, nor lifestyle advice in people with Cardiovascular Diseases and Hypercholesterolemia, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14) (time frame: Baseline and at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.