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Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA): a pragmatic, open-label, randomised controlled trial
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Section of Medicine. (Arcum)
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health. (Arcum)ORCID iD: 0000-0003-0556-1483
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health.
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Family Medicine.
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2019 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 393, no 10167, p. 133-142Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Primary prevention of cardiovascular disease often fails because of poor adherence among practitioners and individuals to prevention guidelines. We aimed to investigate whether ultrasound-based pictorial information about subclinical carotid atherosclerosis, targeting both primary care physicians and individuals, improves prevention.

METHODS: Visualization of asymptomatic atherosclerotic disease for optimum cardiovascular prevention (VIPVIZA) is a pragmatic, open-label, randomised controlled trial that was integrated within the Västerbotten Intervention Programme, an ongoing population-based cardiovascular disease prevention programme in northern Sweden. Individuals aged 40, 50, or 60 years with one or more conventional risk factors were eligible to participate. Participants underwent clinical examination, blood sampling, and ultrasound assessment of carotid intima media wall thickness and plaque formation. Participants were randomly assigned 1:1 with a computer-generated randomisation list to an intervention group (pictorial representation of carotid ultrasound plus a nurse phone call to confirm understanding) or a control group (not informed). The primary outcomes, Framingham risk score (FRS) and European systematic coronary risk evaluation (SCORE), were assessed after 1 year among participants who were followed up. This study is registered with ClinicalTrials.gov, number NCT01849575.

FINDINGS: 3532 individuals were enrolled between April 29, 2013, and June 7, 2016, of which 1783 were randomly assigned to the control group and 1749 were assigned to the intervention group. 3175 participants completed the 1-year follow-up. At the 1-year follow-up, FRS and SCORE differed significantly between groups (FRS 1·07 [95% CI 0·11 to 2·03, p=0·0017] and SCORE 0·16 [0·02 to 0·30, p=0·0010]). FRS decreased from baseline to the 1-year follow-up in the intervention group and increased in the control group (-0·58 [95% CI -0·86 to -0·30] vs 0·35 [0·08 to 0·63]). SCORE increased in both groups (0·13 [95% CI 0·09 to 0·18] vs 0·27 [0·23 to 0·30]).

INTERPRETATION: This study provides evidence of the contributory role of pictorial presentation of silent atherosclerosis for prevention of cardiovascular disease. It supports further development of methods to reduce the major problem of low adherence to medication and lifestyle modification.

Place, publisher, year, edition, pages
Elsevier, 2019. Vol. 393, no 10167, p. 133-142
National Category
Public Health, Global Health, Social Medicine and Epidemiology Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:umu:diva-154318DOI: 10.1016/S0140-6736(18)32818-6ISI: 000455437100026PubMedID: 30522919Scopus ID: 2-s2.0-85058851994OAI: oai:DiVA.org:umu-154318DiVA, id: diva2:1271275
Funder
Västerbotten County Council, Dnr ALFVLL-298001Swedish Research Council, Dnr 521-2013-2708Swedish Research Council, 2016-01891Swedish Heart Lung Foundation, Dnr 20150369Swedish Heart Lung Foundation, 20170481
Note

Erratum: Näslund, U., Ng, N., Lundgren, A., Fhärm, E., Grönlund, C., Johansson, H., … 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. DOI:10.1016/S0140-6736(18)32818-6

Available from: 2018-12-17 Created: 2018-12-17 Last updated: 2023-07-11Bibliographically approved
In thesis
1. Pictorial presentation of subclinical atherosclerosis: a measure to reduce the risk for cardiovascular disease
Open this publication in new window or tab >>Pictorial presentation of subclinical atherosclerosis: a measure to reduce the risk for cardiovascular disease
2021 (English)Doctoral thesis, comprehensive summary (Other academic)
Alternative title[sv]
Visualisering av subklinisk ateroskleros : en metod för att minska risken för hjärt-kärlsjukdom
Abstract [en]

The overall aim was improved cardiovascular disease (CVD) prevention through the VIPVIZA intervention. This includes the provision of pictorial information of subclinical atherosclerosis to participants and their general practitioners (GPs), follow-up phone call, and written information to the participant. VIPVIZA is a Prospective Randomized Open Blinded End-point (PROBE) trial nested within VIP, a CVD prevention program in primary health care in Västerbotten county, Sweden. Middle-aged individuals at low/intermediate CVD risk were enrolled to VIPVIZA and randomized 1:1 to an intervention (n=1749) or control group (n=1783 who received no pictorial or other information). Preventive measures were managed within primary health care.

At baseline, clinical risk factors were measured and carotid ultrasound examination was performed. The prevalence of subclinical atherosclerotic disease was assessed as intima media thickness and presence of plaque. The association between clinical risk factors and measures of subclinical atherosclerosis was investigated. In addition to conventional risk factor-based risk evaluation, the impact of the VIPVIZA intervention on CVD risk, traditional risk factors and pharmacological treatment was evaluated after 1 and 3 years. Individual interviews were conducted with 15 GPs to explore how a pictorial representation of subclinical atherosclerosis affects physicians in their perception and communication of CVD risk. The interviews were analyzed by qualitative content analysis.

The plaque prevalence was 44.7% in this population. Clinical risk factors explained more of the variation in a combined ultrasound measurement than single measurements. The results up to three years showed a VIPVIZA intervention effect, with lower and sustained CVD risk in the intervention as compared to the control group. The effect was partly mediated by differences in intake of lipid-lowering medication and partly by lifestyle behaviour. The GPs described their risk assessment and patients’ risk perception as more accurate with the VIPVIZA intervention. Informing patients about examination results prior to a consultation can facilitate shared decision-making and enhance adherence to preventive measures.

The results show that the VIPVIZA intervention reduces CVD risk over three years. In the long run this has the potential to reduce the incidence of CVD events.

Place, publisher, year, edition, pages
Umeå: Umeå universitet, 2021. p. 85
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 2144
Keywords
Cardiovascular disease, non-adherence, pictorial information, prevention, subclinical atherosclerosis
National Category
Public Health, Global Health, Social Medicine and Epidemiology Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:umu:diva-186699 (URN)978-91-7855-593-2 (ISBN)978-91-7855-592-5 (ISBN)
Public defence
2021-09-17, Zoom, Umeå, 09:00 (Swedish)
Opponent
Supervisors
Note

Zoom: https://umu.zoom.us/j/63352946259?pwd=MU5rVTdUZG1rMzVNTkIxaTl1czB1QT09 Password: 838770

Available from: 2021-08-27 Created: 2021-08-18 Last updated: 2021-08-27Bibliographically approved

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Näslund, UlfNg, NawiLundgren, AnnaFhärm, EvaGrönlund, ChristerJohansson, HeleneLindahl, BerntLindvall, KristinaNilsson, Stefan K.Nordin, MariaNordin, StevenNyman, EmmaRocklöv, JoacimVanoli, DavideWeinehall, LarsWennberg, PatrikWester, PerNorberg, Margareta

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Näslund, UlfNg, NawiLundgren, AnnaFhärm, EvaGrönlund, ChristerJohansson, HeleneLindahl, BerntLindvall, KristinaNilsson, Stefan K.Nordin, MariaNordin, StevenNyman, EmmaRocklöv, JoacimVanoli, DavideWeinehall, LarsWennberg, PatrikWester, PerNorberg, Margareta
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