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Vascular Lifestyle-Intervention and Screening in Pharmacy (VISA)

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ClinicalTrials.gov Identifier: NCT02223793
Recruitment Status : Active, not recruiting
First Posted : August 22, 2014
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
University of Tromso
University of Minnesota - Clinical and Translational Science Institute
Boots Norway AS
Mills DA
Information provided by (Responsible Party):
Karianne Svendsen, University of Oslo

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Hypercholesterolemia Dyslipidemia Hypertensive Disease Diabetes Mellitus, Type 2 Behavioral: Information on high risk factor levels and lifestyle advice Behavioral: No information on high risk factor levels but lifestyle advice Behavioral: No information on high risk factor levels, nor lifestyle advice Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 581 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: 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
Behavioral: 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

Experimental: 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
Behavioral: 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.

Experimental: 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
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




Primary Outcome Measures :
  1. Change in risk score [ Time Frame: Baseline and at 8 weeks ]
    From date of randomization to date of follow up after 8 weeks and follow-up after 52 weeks, 2 years and 5 years. (Total and between groups)


Secondary Outcome Measures :
  1. Change in composite biochemical and anthropometric measurement levels [ Time Frame: At baseline and at 8 weeks ]
    It is a composite measurement of different biochemical and anthropometric measurements of cardiovascular risk. From date of randomization and until the end of the follow up after 8 weeks and follow-up after 52 weeks, 2 years and 5 years (Total and between groups)


Other Outcome Measures:
  1. Change in composite diet and lifestyle parameters [ Time Frame: At baseline and 8 weeks ]
    From date of randomization to end of the follow up after 8 weeks. The measurement is composite, and the main diet parameters will be intake in grams of: fruit and vegetables, intake of fat-rich food items (like meat and meat products and dairy products) and change in fatty acid composition of the diet. Regarding lifestyle, number of cigarettes pr. day and physical activity pr. week will be covered.(Total and between groups)

  2. Effect of heart age and tailord CVD advice after 1 year [ Time Frame: 4 weeks ]
    Comparing results from blood samples after 4 weeks in 23 pharmacies (enhanced CVD communication) versus 25 pharmacies (general communication of CVD risk).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223793


Locations
Norway
University of Oslo
Oslo, P.B. 1046 Blinderen, Norway, 0317
Sponsors and Collaborators
University of Oslo
University of Tromso
University of Minnesota - Clinical and Translational Science Institute
Boots Norway AS
Mills DA
Investigators
Principal Investigator: Karianne Svendsen, M.Sc. University of Oslo

Responsible Party: Karianne Svendsen, PHD student, University of Oslo
ClinicalTrials.gov Identifier: NCT02223793     History of Changes
Other Study ID Numbers: 2013/1660
39255 (NSD) ( Registry Identifier: Norwegian Social Science Data Services )
1660/2013 ( Registry Identifier: Regional committees for medical and health research ethics: South-East )
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by Karianne Svendsen, University of Oslo:
Vascular screening
Cardiovascular risk factors
Blood pressure
Lipids
Lifestyle
Identifying unknown risk
Low socioeconomic status
low threshold

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Hypercholesterolemia
Dyslipidemias
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Vascular Diseases