Clinical trial NCT02223793: Vascular Lifestyle-Intervention and Screening in Pharmacy
Official title: Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: University of Minnesota
name: Boots Norway AS
name: Mills DA
First posted: 2014-08-22
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)
timeFrame: Baseline and at 8 weeks
Secondary outcomes:
measure: 8-week Change in Total Cholesterol
timeFrame: At baseline and at 8 weeks
Other outcomes:
measure: Effect of Heart Age and Tailord CVD Advice After 1 Year
timeFrame: 4 weeks
Locations:
city: Oslo
country: Norway
facility: University of Oslo
state: P.B. 1046 Blinderen
Study officials:
affiliation: University of Oslo
name: Karianne Svendsen, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.