Vascular Lifestyle-Intervention and Screening in Pharmacy

Diabetes Mellitus, Type 2 Clinical Trial

— VISA  

Official title:

Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02223793
• Other study ID #: 2013/1660
• Secondary ID: 39255 (NSD)1660/
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: February 2022

Study information

• Verified date: April 2020
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 582
• Est. completion date: February 2022
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia
• Hypertension
• Hypertensive Disease

Intervention

Behavioral:
• 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
• 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
• 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.

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo	P.B. 1046 Blinderen

Sponsors (5)

Lead Sponsor	Collaborator
University of Oslo	Boots Norway AS, Mills DA, University of Minnesota, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	4 weeks
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.	Baseline and at 8 weeks
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.	At baseline and at 8 weeks