Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of Oslo
Sponsor:
Collaborators:
University of Tromso
University of Minnesota - Clinical and Translational Science Institute
Boots Norway AS
Mills DA, Norway
Information provided by (Responsible Party):
Karianne Svendsen, University of Oslo
ClinicalTrials.gov Identifier:
NCT02223793
First received: August 18, 2014
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Change in risk score (NORRISK) [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
    From date of randomization to date of follow up after 8 weeks and follow-up after 52 weeks, 2 years and 5 years


Secondary Outcome Measures:
  • Change in composite biochemical and anthropometric measurement levels [ Time Frame: At baseline and at 8 weeks ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Change in composite diet and lifestyle parameters [ Time Frame: At baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: September 2014
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02223793

Contacts
Contact: Karianne Svendsen, M.Sc. 004795026445 karianne.svendsen@medisin.uio.no
Contact: Kjetil Retterstol, Phd and M.D. 004722851521 kjetil.retterstol@medisin.uio.no

Locations
Norway
University of Oslo Not yet recruiting
Oslo, P.B. 1046 Blinderen, Norway, 0317
Contact: Kjersti Garstad       k.garstad@boots.no   
Contact: Lisa Mørch-Reiersen       L.Morch-Reiersen@boots.no   
Principal Investigator: Kjetil Retterstøl, PhD, M.D.         
Principal Investigator: Vibeke Telle-Hansen, PhD, M.Sc         
Sponsors and Collaborators
University of Oslo
University of Tromso
University of Minnesota - Clinical and Translational Science Institute
Boots Norway AS
Mills DA, Norway
Investigators
Principal Investigator: Karianne Svendsen, M.Sc. University of Oslo
  More Information

No publications provided

Responsible Party: Karianne Svendsen, PHD student, University of Oslo
ClinicalTrials.gov Identifier: NCT02223793     History of Changes
Other Study ID Numbers: 2013/1660, 39255 (NSD), 1660/2013
Study First Received: August 18, 2014
Last Updated: August 20, 2014
Health Authority: Norway: Ethics Committee
Norway: Norwegian Social Science Data Services

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

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

ClinicalTrials.gov processed this record on September 22, 2014