VIPVIZA - VIsualiZation of asymptomatic Atherosclerotic disease for optimum cardiovascular prevention ─ a randomized controlled trial nested in the Västerbotten Intervention Program
Documentation files
Documentation files
Citation and access
Citation and access
Creator/Principal investigator(s):
- Ulf Näslund - Umeå University - Public Health and Clinical Medicine
- Patrik Wennberg - Umeå University - Family Medicine
- Umeå University - Department of Public Health and Clinical Medicine
Research principal:
Data contains personal data:
Yes
Type of personal data:
Medical data at individual level
Code key exists:
Yes
Sensitive personal data:
Yes
Citation:
Data access level:
Language:
Method and outcome
Method and outcome
Unit of analysis:
Population:
Healthy subjects aged 40-60 years at low/moderate risk of cardiovascular disease
Study design:
- Randomised controlled trial (RCT)
- Experimental study
Description of study design:
Pagmatic open-label, randomised controlled trial with masked evaluators (PROBE)
Sampling procedure:
Description of sampling:
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:
Number of individuals/objects:
3532
Data format/data structure:
Data collections - 15 collections
Data collections - 15 collections
Data collection - Registry extract and/or access to biobank sample
Data collection - Registry extract and/or access to biobank sample
Mode of collection:
Registry extract and/or access to biobank sample
Description of the mode of collection:
VIP historical data 20 years before basline
Time period(s) for data collection:
1992 - 1998
Data collection - Registry extract and/or access to biobank sample
Data collection - Registry extract and/or access to biobank sample
Mode of collection:
Registry extract and/or access to biobank sample
Description of the mode of collection:
VIP Historical data 10 years before baseline
Time period(s) for data collection:
2000 - 2009
Source of the data:
- Registers/Records/Accounts
Data collection - Registry extract and/or access to biobank sample
Data collection - Registry extract and/or access to biobank sample
Mode of collection:
Registry extract and/or access to biobank sample
Description of the mode of collection:
The Swedish Prescribed Drug Register
Time period(s) for data collection:
2011-01-02 - 2020-09-30
Data collection - Registry extract and/or access to biobank sample
Data collection - Registry extract and/or access to biobank sample
Mode of collection:
Registry extract and/or access to biobank sample
Description of the mode of collection:
VIP baseline (lifestyle)
Time period(s) for data collection:
2012-04-11 - 2016-06-01
Source of the data:
- Registers/Records/Accounts
Data collection - Physical measurements and tests
Data collection - Physical measurements and tests
Mode of collection:
Physical measurements and tests
Description of the mode of collection:
Ultrasound baseline
Time period(s) for data collection:
2013-04-27 - 2016-06-07
Source of the data:
- Research data
Instrument
Instrument
Name:
Description of the 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
Data collection - Self-administered questionnaire
Data collection - Self-administered questionnaire
Mode of collection:
Self-administered questionnaire
Description of the mode of collection:
Psychological (Problem management) , baseline
Time period(s) for data collection:
2013-04-29 - 2016-06-07
Source of the data:
- Research data
Instrument
Instrument
Name:
GSE, General Self-Efficacy Scale
Description of the instrument:
Self-report measure of general self-efficacy, an individual's belief in his or her capacity to execute behaviors necessary to produce performance attainments
Name:
LOT-R Life Orientation Test-Revised
Description of the instrument:
Self-report instrument that assesses one’s dispositional level of optimism/pessimism
Name:
HADS Hpiostal Anxiety and Depression Scale
Description of the instrument:
Self-assessment form for anxiety (subscale HADS-anxiety, 7 questions) and depression (subscale HADS-depression, 7 questions)
Name:
Description of the instrument:
Self-rated risk of CVD - VAS-scale
Name:
Brief Health Literacy Screen (BHLS)
Description of the instrument:
Three questions on self-rated health literacy according to Chew
Name:
Brief Cope
Description of the instrument:
Self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event
Data collection - Self-administered questionnaire
Data collection - Self-administered questionnaire
Mode of collection:
Self-administered questionnaire
Description of the mode of collection:
Lifestyle 1 year
Time period(s) for data collection:
2014-05-08 - 2017-11-01
Source of the data:
- Research data
Data collection - Biological tests
Data collection - Biological tests
Mode of collection:
Biological tests
Description of the mode of collection:
Lifestyle 1 year
Time period(s) for data collection:
2014-05-08 - 2017-11-01
Data collector:
- Umeå University
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ROROpens in a new tab
Source of the data:
- Research data
Data collection - Self-administered questionnaire
Data collection - Self-administered questionnaire
Mode of collection:
Self-administered questionnaire
Description of the mode of collection:
Clinical CVD risk factors and lifestyle habits 3 year
Time period(s) for data collection:
2016-01-14 - 2019-06-14
Data collection - Measurements and tests
Data collection - Measurements and tests
Mode of collection:
Measurements and tests
Description of the mode of collection:
Clinical CVD risk factors and lifestyle habits 3 year
Time period(s) for data collection:
2016-01-16 - 2019-06-14
Data collection - Physical measurements and tests
Data collection - Physical measurements and tests
Mode of collection:
Physical measurements and tests
Description of the mode of collection:
Ultrasound 3 year
Time period(s) for data collection:
2016-09-05 - 2019-05-28
Source of the data:
- Research data
Instrument
Instrument
Name:
Description of the 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
Data collection - Self-administered questionnaire
Data collection - Self-administered questionnaire
Mode of collection:
Self-administered questionnaire
Description of the mode of collection:
Psykologiska faktorer och reaktioner på VIPVIZA interventionen (Problemhantering), efter 3 år
Time period(s) for data collection:
2016-09-05 - 2019-05-28
Instrument
Instrument
Name:
GSE General Self Efficacy Scale
Description of the instrument:
Self-report measure of general self-efficacy, an individual's belief in his or her capacity to execute behaviors necessary to produce performance attainments
Name:
LOT-R Life Orientation Test - Revised
Description of the instrument:
Self-report instrument that assesses one’s dispositional level of optimism/pessimism
Name:
Brief Cope
Description of the instrument:
Self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event
Name:
Description of the 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
Name:
BHLS Brief Health Literacy Screen
Description of the instrument:
Three questions on self-rated health literacy, according to Chew
Name:
HADS Hospital Anxiety Depression Scale
Description of the instrument:
Self-assessment form for anxiety (subscale HADS-anxiety, 7 questions) and depression (subscale HADS-depression, 7 questions)
Name:
SMBQ Shirom-Melamed Burnout Questionnaire
Description of the instrument:
Questionnaire to evaluate burnout
Data collection
Data collection
Description of the mode of collection:
Included study participants
Time period(s) for data collection:
2017-01-19 - 2017-01-19
Source of the data:
- Research data
Instrument
Instrument
Name:
Case Report Form
Data collection - Registry extract and/or access to biobank sample
Data collection - Registry extract and/or access to biobank sample
Mode of collection:
Registry extract and/or access to biobank sample
Description of the mode of collection:
Military service mustering register
Data collector:
- Riksarkivet
Source of the data:
- Registers/Records/Accounts
Data collection - Biological tests
Data collection - Biological tests
Mode of collection:
Biological tests
Description of the mode of collection:
Included study participants
Geographic coverage
Geographic coverage
Geographic location:
Geographic description:
Region Västerbotten
Highest geographic unit:
Region
Administrative information
Administrative information
Responsible department/unit:
Department of Public Health and Clinical Medicine
Contributor(s):
- Wolfgang Lohr - Umeå University - Department of Epidemiology and Global HEalth
Ethics Review:
Swedish Ethical Review Authority - 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
Funding
Funding
Funding agency:
- Carl Bennet Ltd, Sweden
Funding agency:
- The Swedish Insurance Society
Funding agency:
- The Heart Foundation in Northern Sweden
Funding agency:
- Swedish Society of Medicine
Award number:
405351, 503111
Funding agency:
- Visare Norr (the four Northern Regions)
Award number:
465621, 561591, 741711, 931135
Funding agency:
- The Swedish Research Council
Award number:
Dnr 521-2013-2708, 2016-01891, 2017-02246
Funding agency:
- Region Västerbotten
Award number:
ALFVLL-298001, ALFVLL-643391
Funding agency:
- The Heart and Lung Foundation
Award number:
Dnr 20150369, 20170481)
Funding agency:
- SKANDIA Risk & Health
Topic and keywords
Topic and keywords
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Relations
Homepage:
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Publications
Publications
Citation:
Citation:
Citation:
Citation:
ISBN:
978-91-7601-748-7