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

Data collection 1

• 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 2

• 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 3

• 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 4

• 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 5

• 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
• 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

Data collection 6

• 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
• 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
• Instrument: Brief Cope - Self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event
• Source of the data: Research data

Data collection 7

• 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 8

• 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
• Source of the data: Research data

Data collection 9

• 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 10

• 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 11

• 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
• 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

Data collection 12

• 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: 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

Data collection 13

• Description of the mode of collection: Included study participants
• Time period(s) for data collection: 2017-01-19 – 2017-01-19
• Instrument: Case Report Form
• Source of the data: Research data

Data collection 14

• 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 15

• Mode of collection: Biological tests
• Description of the mode of collection: Included study participants

Funding 1

• Funding agency: Carl Bennet Ltd, Sweden

Funding 2

• Funding agency: The Swedish Insurance Society

Funding 3

• Funding agency: The Heart Foundation in Northern Sweden

Funding 4

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

Funding 5

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

Funding 6

• Funding agency: The Swedish Research Council
• Funding agency's reference number: Dnr 521-2013-2708, 2016-01891, 2017-02246

Funding 7

• Funding agency: Region Västerbotten
• Funding agency's reference number: ALFVLL-298001, ALFVLL-643391

Funding 8

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

Funding 9

• Funding agency: SKANDIA Risk & Health