Vascular Lifestyle-Intervention and Screening in Pharmacy

NCT ID: NCT02223793

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 582 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2022-02-28

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.

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Dyslipidemia; Hypertensive Disease; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

No information on high risk factor levels but lifestyle advice

Intervention Type: BEHAVIORAL

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 not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline

Group Type: EXPERIMENTAL

No information on high risk factor levels, nor lifestyle advice

Intervention Type: BEHAVIORAL

In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.

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

Group Type: EXPERIMENTAL

Information on high risk factor levels and lifestyle advice

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Tromso

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Boots Norway AS

UNKNOWN

Sponsor Role: collaborator

Mills DA

INDUSTRY

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Karianne Svendsen

PHD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karianne Svendsen, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

University of Oslo

Oslo, P.B. 1046 Blinderen, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 30191097 (View on PubMed)

Other Identifiers

39255 (NSD)

Identifier Type: REGISTRY

Identifier Source: secondary_id

1660/2013

Identifier Type: REGISTRY

Identifier Source: secondary_id

2013/1660

Identifier Type: -

Identifier Source: org_study_id