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VIPVIZA VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program

SND-ID: 2020-204

Alternative title

VIPVIZA

Creator/Principal investigator(s)

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Patrik Wennberg - Umeå University, Family Medicine

Christer Grönlund - Umeå University, Department of Radiation Sciences

Per Wester - Umeå University , Public Health and Clinical medicine

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Description

The aim of the project is to develop better methods for prevention of cardiovascular diseases (CVD). It is based on the hypothesis that image-based information on subclinical atherosclerosis (i) increases the precision in the assessment of risk of CVD, (ii) improves communication and understanding of the risk, and as a consequence (iii) the motivation for and adherence to evidence-based pharmacological treatment and lifestyle modification will increase. In addition to conventional risk factor assessment and CVD prevention within the framework of Västerbotten Intervention Program.

3500 healthy participants with low/moderate risk of CVD underwent ultrasound examination of the carotid arteries and were randomized to two groups. In the intervention group, the participants and their doctors received pictorial and graphic information in color about the participant’s subclinical atherosclerosis. No information about the ultrasound results was given to the control group. Follow-up after 1, 3 and 6.5 years includes sampling regarding clinical risk factors, blood for biomarker analyses, extensive quest

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Language

English

Research principal, contributors, and funding

Research principal

Umeå University

Responsible department/unit

Department of Public Health and Clinical Medicine

Contributor(s)

Wolfgang Lohr - Umeå University, Department of Epidemiology and Global HEalth

Funding 1

  • Funding agency: Swedish Society of Medicine
  • Funding agency's reference number: 405351, 503111

Funding 2

  • Funding agency: The Heart and Lung Foundation
  • Funding agency's reference number: Dnr 20150369, 20170481)

Funding 3

  • Funding agency: SKANDIA Risk & Health

Funding 4

  • Funding agency: Visare Norr (the four Northern Regions)
  • Funding agency's reference number: 465621, 561591, 741711, 931135

Funding 5

  • Funding agency: Carl Bennet Ltd, Sweden
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Protection and ethical review

Data contains personal data

Yes

Sensitive personal data

Yes

Type of personal data

Medical data at individual level

Code key exists

Yes

Ethics Review

Swedish Ethical Review Authority - Ref. Dnr 2011-441-31M. Amendments:Dnr 2012-463-32M, Dnr 2013-373-32M, Dnr 2016-245-32M, Dnr 2017-95-32M, Dnr 2018-182-32, Dnr 2018-482-32M, Dnr 2019-0691, Dnr Ö 23-2020/3.1

Method and time period

Unit of analysis

Population

Healthy subjects aged 40-60 years at low/moderate risk of cardiovascular disease

Study design

Randomised controlled trial (RCT)

Description of study design

Pagmatic open-label, randomised controlled trial with masked evaluators (PROBE)

Sampling procedure

Other
Subjects having at least one cardiovascular risk factor at the occasion of participation in the Västerbotten INtervention Programme: 1) age 40 years and a first-degree relative with a history oc cardiovascular disease at an age younger than 60 years, abdominal obesity, hypertension, diabetes, LDL-cholesterol >= 4.5 mmol/l, smoking. 3) Age 60 years.
Exclusion criterion: More than 50% narrowing of the lumen of carotid areteries

Time period(s) investigated

2013-04-29 – ongoing

Biobank is connected to the study

Yes

Geographic coverage

Geographic spread

Geographic location: Västerbotten County

Geographic description: Region Västerbotten

Highest geographic unit

Region

Topic and keywords

Research area

Cardiac and Cardiovascular Systems, Radiology, Nuclear Medicine and Medical Imaging, Clinical Laboratory Medicine, General Practice, Public Health, Global Health, Social Medicine and Epidemiology, Medical Biotechnology (focus on Cell Biology (incl. Stem Cell Biology), Molecular Biology, Microbiology, Biochemistry or Biopharmacy), Psychology (The Swedish standard of fields of research 2011)

Keywords

biomedical research, cardiovascular diseases, primary prevention, ultrasonography, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information, plaque, arteriosclerosis

Publications

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Bengtsson, A., Norberg, M., Ng, N., Carlberg, B., Grönlund, C., Hultdin, J., ... & Näslund, U. (2021). The beneficial effect over 3 years by pictorial information to patients and their physician about subclinical atherosclerosis and cardiovascular risk: Results from the VIPVIZA randomized clinical trial. American Journal of Preventive Cardiology, 7, 100199.
DOI: https://doi.org/10.1016/j.ajpc.2021.100199

Vanoli, D. (2017). Vascular ultrasound for the assessment of carotid atherosclerosis [PhD dissertation, Umeå University]. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-139538
ISBN: 978-91-7601-748-7
URN: urn:nbn:se:umu:diva-139538

Vanoli, D., Lindqvist, P., Wiklund, U., Henein, M., & Näslund, U. (2013). Fully automated on-screen carotid intima-media thickness measurement : a screening tool for subclinical atherosclerosis. Journal of Clinical Ultrasound, 41(6), 333–339. https://doi.org/10.1002/jcu.22041
URN: urn:nbn:se:umu:diva-78429
DOI: https://doi.org/10.1002/jcu.22041

Bengtsson, A., Lindvall, K., Norberg, M., & Fhärm, E. (2021). Increased knowledge makes a difference!–general practitioners’ experiences of pictorial information about subclinical atherosclerosis for primary prevention: an interview study from the VIPVIZA trial. Scandinavian Journal of Primary Health Care, 39(1), 77-84.
DOI: https://doi.org/10.1080/02813432.2021.1882083.
URN: urn:nbn:se:umu:diva-78429

Vanoli, D., Wiklund, U., Lindqvist, P., Henein, M., & Näslund, U. (2014). Successful novice’s training in obtaining accurate assessment of carotid IMT using an automated ultrasound system. European Heart Journal Cardiovascular Imaging, 15(6), 637–642. https://doi.org/10.1093/ehjci/jet254
DOI: https://doi.org/10.1093/ehjci/jet254
URN: urn:nbn:se:umu:diva-91057

Lindahl, B., Norberg, M., Johansson, H., Lindvall, K., Ng, N., Nordin, M., Nordin, S., Näslund, U., Persson, A., Vanoli, D., & Schulz, P. J. (2020). Health literacy is independently and inversely associated with carotid artery plaques and cardiovascular risk. European Journal of Preventive Cardiology, 27(2), 209–215. https://doi.org/10.1177/2047487319882821
DOI: https://doi.org/10.1177/2047487319882821
URN: urn:nbn:se:umu:diva-165791

Nyman, E., Vanoli, D., Näslund, U., & Grönlund, C. (2020). Inter-sonographer reproducibility of carotid ultrasound plaque detection using Mannheim consensus in subclinical atherosclerosis. Clinical Physiology and Functional Imaging, 40(1), 46–51. https://doi.org/10.1111/cpf.12602
DOI: https://doi.org/10.1111/cpf.12602
URN: urn:nbn:se:umu:diva-165443

Näslund, U., Ng, N., Lundgren, A., Fhärm, E., Grönlund, C., Johansson, H., Lindahl, B., Lindahl, B., Lindvall, K., Nilsson, S. K., Nordin, M., Nordin, S., Nyman, E., Rocklöv, J., Vanoli, D., Weinehall, L., Wennberg, P., Wester, P., & Norberg, M. (2019). Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) : a pragmatic, open-label, randomised controlled trial. The Lancet, 393(10167), 133–142. https://doi.org/10.1016/S0140-6736(18)32818-6
DOI: https://doi.org/10.1016/S0140-6736(18)32818-6
URN: urn:nbn:se:umu:diva-154318

Nyman, E., Lindqvist, P., Näslund, U., & Grönlund, C. (2018). Risk Marker Variability in Subclinical Carotid Plaques Based on Ultrasound is Influenced by Cardiac Phase, Echogenicity and Size. Ultrasound in medicine & biology, 44(8), 1742–1750.
DOI: https://doi.org/10.1016/j.ultrasmedbio.2018.03.013

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Dataset 1
VIPVIZA - Included study participants

Description

Included participants. Date for Informed Consent. Date for inclusion (= date for the baseline ultrasound examination). Randomization group. Participation in study waves baseline, 1 year, 3 years and 6 years. Number of days between measurements in VIP and measurements at 1-year, 3-year- and 6-year follow-up visits.

Data format / data structure

Numeric

Creator/Principal investigator(s)

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Patrik Wennberg - Umeå University, Family Medicine

Umeå University, Department of Public Health and Clinical Medicine

Keywords

randomized controlled trial

Time period(s) investigated

2013 – ongoing

Data collection 1

  • Time period(s) for data collection: 2017-01-19
  • Instrument: Case Report Form
  • Source of the data: Research data

Data collection 2

  • Mode of collection: Biological tests
  • Instrument:

Variables

16

Number of individuals/objects

3532

Dataset 2
VIP baseline (lifestyle)

Description

Variables from participation in Västerbotten Intervention Programme (VIP) at baseline:
Clinincal risk factors for cardiovascular disease, and
Questionnaire data from VIP containing demography, socio-economy, health, medication regarding prevention of CVD, quality of life (RAND36), lide style habits, Social network (ISSI), work related stress (Karasek).

Data format / data structure

Numeric

Creator/Principal investigator(s)

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Patrik Wennberg - Umeå University, Family Medicine

Nawi Ng - University of Gothenburg, Institute of Medicine, Sahlgrenska Academy

Johan Hultdin - Umeå University, Department of Medical Biosciences

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Keywords

biomedical research, cardiovascular diseases, primary prevention, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information

Time period(s) investigated

2012 – 2016

Data collection

  • Mode of collection: Registry extract and/or access to biobank sample
  • Time period(s) for data collection: 2012-04-11–2016-06-01
  • Source of the data: Registers/Records/Accounts

Variables

444

Number of individuals/objects

3532

Response rate/participation rate

100%

Dataset 4
Lifestyle 1 year

Description

Clinical risk factors, lifestyle, preventive medication, quality of life.
The same measurements (except only fasting glucose, not OGTT), and questionnaires regarding lifestyle, quality of life and medication as in the VIP questionnaire at baseline.

Data format / data structure

Numeric

Creator/Principal investigator(s)

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Patrik Wennberg - Umeå University, Family Medicine

Nawi Ng - University of Gothenburg, Institute of Medicine, Sahlgrenska Academy

Johan Hultdin - Umeå University, Department of Medical Biosciences

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Keywords

biomedical research, cardiovascular diseases, primary prevention, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information

Data collection 1

  • Mode of collection: Self-administered questionnaire
  • Time period(s) for data collection: 2014-05-08–2017-11-01
  • Source of the data: Research data

Data collection 2

  • Mode of collection: Biological tests
  • Time period(s) for data collection: 2014-05-08–2017-11-01
  • Source of the data: Research data

Variables

203

Number of individuals/objects

3175

Dataset 5
Clinical CVD risk factors and lifestyle habits 3 year

Description

Clinical risk factors, lifestyle, preventive medication, quality of life.
The same measurements (only fasting glucose, not OGTT), and questionnaires regarding lifestyle, quality of life and medication as in the VIP questionnaire at baseline.

Data format / data structure

Numeric

Creator/Principal investigator(s)

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Patrik Wennberg - Umeå University, Family Medicine

Nawi Ng - University of Gothenburg, Institute of Medicine, Sahlgrenska Academy

Johan Hultdin - Umeå University, Department of Medical Biosciences

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Keywords

biomedical research, cardiovascular diseases, primary prevention, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information

Data collection 1

  • Mode of collection: Measurements and tests
  • Time period(s) for data collection: 2016-01-16–2019-06-14

Data collection 2

  • Mode of collection: Self-administered questionnaire
  • Time period(s) for data collection: 2016-01-16–2019-06-14

Variables

272

Number of individuals/objects

3138

Dataset 6
Ultrasound baseline

Description

Carotid ultrasound examination with Intima Media Thickness (IMT) measured in several insonation angles according to a standardized protocol and detection of plaques, as well as information to the intervention group regarding vascular age and presence of plaques

Data format / data structure

Numeric

Creator/Principal investigator(s)

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Christer Grönlund - Umeå University, Department of Radiation Sciences

Per Wester - Umeå University , Public Health and Clinical medicine

Umeå University, Department of Public Health and Clinical Medicine

Keywords

biomedical research, cardiovascular diseases, primary prevention, ultrasonography, randomized controlled trial, risk assessment, consumer health information

Data collection

  • Mode of collection: Physical measurements and tests
  • Time period(s) for data collection: 2013-04-27–2016-06-07
  • Instrument: CardioHealth Station, Panasonic Healthcare Corporation of North America, Newark, NJ, USA - A portable ultrasound system with a linear 7MHz transducer, Ultrasound 2D, B-mode settings including depth, gain and focus point were optimized for each participant manually by the sonographer. CardioHealth Station, Panasonic Healthcare Corporation of North America, Newark, NJ, USA
  • Source of the data: Research data

Variables

39

Number of individuals/objects

3532

Dataset 7
Ultrasound 3 year

Description

Carotid ultrasound examination with Intima Media Thickness (IMT) measured in several insonation angles according to a standardized protocol and detection of plaques, as well as information to the intervention group regarding vascular age and presence of plaques

Data format / data structure

Numeric

Creator/Principal investigator(s)

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Christer Grönlund - Umeå University, Department of Radiation Sciences

Per Wester - Umeå University , Public Health and Clinical medicine

Umeå University, Department of Public Health and Clinical Medicine

Keywords

biomedical research, cardiovascular diseases, primary prevention, ultrasonography, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information

Data collection

  • Mode of collection: Physical measurements and tests
  • Time period(s) for data collection: 2016-09-05–2019-05-28
  • Instrument: CardioHealth Station, Panasonic Healthcare Corporation of North America, Newark, NJ, USA - A portable ultrasound system with a linear 7MHz transducer, Ultrasound 2D, B-mode settings including depth, gain and focus point were optimized for each participant manually by the sonographer. CardioHealth Station, Panasonic Healthcare Corporation of North America, Newark, NJ, USA
  • Source of the data: Research data

Variables

37

Number of individuals/objects

3154

Dataset 8
Psychological (Problem management) , baseline

Description

Validated questionnaires on psychological factors of importance for the development of CVD.
Examples: Health literacy, anxiety/depression, coping mechanisms, general self efficacy, optimism/pessimism.
Self-rated risk of CVD and specific self efficacy.

Data format / data structure

Numeric

Creator/Principal investigator(s)

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Steven Nordin - Umeå University, Department of Psychology

Bernt Lindahl - Umeå University, Department of Public Health and Clinical Medicine

Umeå University, Department of Public Health and Clinical Medicine

Keywords

biomedical research, cardiovascular diseases, primary prevention, ultrasonography, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information

Data collection

  • Mode of collection: Self-administered questionnaire
  • Time period(s) for data collection: 2013-04-29–2016-06-07
  • Instrument: Brief Cope - Self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event
  • Instrument: GSE, General Self-Efficacy Scale - Self-report measure of general self-efficacy, an individual's belief in his or her capacity to execute behaviors necessary to produce performance attainments
  • Instrument: LOT-R Life Orientation Test-Revised - Self-report instrument that assesses one’s dispositional level of optimism/pessimism
  • Instrument: HADS Hpiostal Anxiety and Depression Scale - Self-assessment form for anxiety (subscale HADS-anxiety, 7 questions) and depression (subscale HADS-depression, 7 questions)
  • Instrument: Self-rated risk of CVD - VAS-scale
  • Instrument: Brief Health Literacy Screen (BHLS) - Three questions on self-rated health literacy according to Chew
  • Source of the data: Research data
Dataset 9
Psychological factors and reactions to the VIPVIZA intervention (Problem management), 3 years

Description

Validated questionnaires on psychological factors of importance for the development of CVD.
Examples: Health literacy, anxiety/depression, coping mechanisms, general self efficacy, stress/burnout, optimism/pessimism, self-rated risk of CVD, Burnout.
Self-rated risk of CVD, specific self efficacy, attitudes to life style habits
Intervention group: Reactions to and impact of the ultrasound report

Data format / data structure

Numeric

Text

Creator/Principal investigator(s)

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Steven Nordin - Umeå University, Department of Psychology

Bernt Lindahl - Umeå University, Department of Public Health and Clinical Medicine

Umeå University, Department of Public Health and Clinical Medicine

Keywords

cardiovascular diseases, primary prevention, randomized controlled trial, risk assessment, risk reduction behavior

Data collection

  • Mode of collection: Self-administered questionnaire
  • Time period(s) for data collection: 2016-09-05–2019-05-28
  • Instrument: GSE General Self Efficacy Scale - Self-report measure of general self-efficacy, an individual's belief in his or her capacity to execute behaviors necessary to produce performance attainments
  • Instrument: LOT-R Life Orientation Test - Revised - Self-report instrument that assesses one’s dispositional level of optimism/pessimism
  • Instrument: Brief Cope - Self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event
  • Instrument: Specific VIPVIZA questionnaire - Self-rated risk of CVDm Specific self-efficacy, attitudes and norms related to life style habits. To the intervention group: Emotional and cognitive reactions and impact of the intervention
  • Instrument: BHLS Brief Health Literacy Screen - Three questions on self-rated health literacy, according to Chew
  • Instrument: HADS Hospital Anxiety Depression Scale - Self-assessment form for anxiety (subscale HADS-anxiety, 7 questions) and depression (subscale HADS-depression, 7 questions)
  • Instrument: SMBQ Shirom-Melamed Burnout Questionnaire - Questionnaire to evaluate burnout
Dataset 10
The Swedish Prescribed Drug Register

Description

All prescribed drugs dispensed at pharmacies.

Data format / data structure

Numeric

Creator/Principal investigator(s)

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Bo Carlberg - Umeå University, Department of Public Health and Clinical Medicine

Maria Sjölander - Umeå University, Department of Integrative Medical Biology

Umeå University, Department of Public Health and Clinical Medicine

Keywords

biomedical research, cardiovascular diseases, primary prevention

Data collection

  • Mode of collection: Registry extract and/or access to biobank sample
  • Time period(s) for data collection: 2011-01-02–2020-09-30
Dataset 11
VIP Historical data 10 years before baseline

Description

The same data as the baseline data from Västerbotten Intervention Programme (VIP): Measured clinical CVD risk factors, questionnaires on lifestyle habits, quality of life , health, demograpgy, socio-economy, living conditions, self-reported pharmacological treatments

Data format / data structure

Numeric

Creator/Principal investigator(s)

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Patrik Wennberg - Umeå University, Family Medicine

Johan Hultdin - Umeå University, Department of Medical Biosciences

Maria Wennberg - Umeå University, Department of Public Health and Clinical Medicine

Umeå University, Department of Public Health and Clinical Medicine

Keywords

biomedical research, cardiovascular diseases, primary prevention, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information

Data collection 1

  • Mode of collection: Registry extract and/or access to biobank sample
  • Time period(s) for data collection: 2000–2009
  • Source of the data: Registers/Records/Accounts

Data collection 2

Dataset 12
VIP historical data 20 years before basline

Data format / data structure

Numeric

Creator/Principal investigator(s)

Ulf Näslund - Umeå University, Public Health and Clinical Medicine

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Patrik Wennberg - Umeå University, Family Medicine

Maria Wennberg - Umeå University, Department of Public Health and Clinical Medicine

Anders Själander - Umeå University, Department of Public Health and Clinical Medicine

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Keywords

biomedical research, cardiovascular diseases, primary prevention, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information

Data collection

  • Mode of collection: Registry extract and/or access to biobank sample
  • Time period(s) for data collection: 1992–1998
  • Source of the data: Registers/Records/Accounts
Dataset 13
Military service mustering register

Description

Physical and psychological tests at the mustering for military service. Men only at ages around 18-21 years.

Data format / data structure

Numeric

Creator/Principal investigator(s)

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Patrik Wennberg - Umeå University, Family Medicine

Steven Nordin - Umeå University, Department of Psychology

Umeå University, Department of Public Health and Clinical Medicine

Keywords

biomedical research, cardiovascular diseases, primary prevention, ultrasonography, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information

Data collection

  • Mode of collection: Registry extract and/or access to biobank sample
  • Source of the data: Registers/Records/Accounts
Dataset 14
Data from Statistics Sweden

Description

Highest attain educational level and Disposable income

Data format / data structure

Numeric

Creator/Principal investigator(s)

Margareta Norberg - Umeå University, Department of Epidemiology and Global Health orcid

Steven Nordin - Umeå University, Department of Psychology

Umeå University, Department of Public Health and Clinical Medicine

Keywords

biomedical research, cardiovascular diseases, primary prevention, randomized controlled trial, risk assessment, risk reduction behavior, consumer health information

Time period(s) investigated

2011 – 2018

Variables

13

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Published: 2021-11-19