Vascular Lifestyle-Intervention and Screening in Pharmacy
VISA
Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study
3 other identifiers
interventional
582
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Sep 2014
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2014
CompletedFirst Posted
Study publicly available on registry
August 22, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedResults Posted
Study results publicly available
October 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMay 6, 2020
April 1, 2020
1.2 years
August 18, 2014
September 17, 2018
April 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
8-week Change in Total Cholesterol
At baseline and at 8 weeks
Other Outcomes (1)
Effect of Heart Age and Tailord CVD Advice After 1 Year
4 weeks
Study Arms (3)
No information on high risk factor levels but lifestyle advice
EXPERIMENTALThis 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
EXPERIMENTALIn 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
EXPERIMENTALThis 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
Interventions
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
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
In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oslolead
- University of Tromsocollaborator
- University of Minnesotacollaborator
- Boots Norway AScollaborator
- Mills DAcollaborator
Study Sites (1)
University of Oslo
Oslo, P.B. 1046 Blinderen, 0317, Norway
Related Publications (1)
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.
PMID: 30191097DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karianne Svendsen
- Organization
- University of Oslo
Study Officials
- PRINCIPAL INVESTIGATOR
Karianne Svendsen, M.Sc.
University of Oslo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD student
Study Record Dates
First Submitted
August 18, 2014
First Posted
August 22, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2015
Study Completion
February 1, 2022
Last Updated
May 6, 2020
Results First Posted
October 3, 2019
Record last verified: 2020-04