Dataset Information

Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention.

ABSTRACT:

Introduction

Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking.

Methods and analysis

The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners' offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed.

Ethics and dissemination

This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study's course and findings through regular meetings.

Trial registration number

NCT05339841.

SUBMITTER: Baldassarre D

PROVIDER: S-EPMC10351259 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention.

Baldassarre Damiano D Iacoviello Licia L Baetta Roberta R Roncaglioni Maria Carla MC Condorelli Gianluigi G Remuzzi Giuseppe G Gensini Gianfranco G Frati Luigi L Ricciardi Walter W Conaldi Pier Giulio PG Uccelli Antonio A Blandini Fabio F Bosari Silvano S Scambia Giovanni G Fini Massimo M Di Malta Antonio A Amato Mauro M Veglia Fabrizio F Bonomi Alice A Klersy Catherine C Colazzo Francesca F Pengo Martino M Gorini Francesca F Auteri Luciana L Ferrante Giuseppe G Baviera Marta M Ambrosio Giuseppe G Catapano Alberico A Gialluisi Alessandro A Malavazos Alexis Elias AE Castelvecchio Serenella S Corsi-Romanelli Massimiliano Marco MM Cardani Rosanna R La Rovere Maria Teresa MT Agnese Valentina V Pane Bianca B Prati Daniele D Spinardi Laura L Liuzzo Giovanna G Arbustini Eloisa E Volterrani Maurizio M Visconti Marco M Werba José Pablo JP Genovese Stefano S Bilo Grzegorz G Invitti Cecilia C Di Blasio Anna A Lombardi Carolina C Faini Andrea A Rosa Debora D Ojeda-Fernández Luisa L Foresta Andreana A De Curtis Amalia A Di Castelnuovo Augusto A Scalvini Simonetta S Pierobon Antonia A Gorini Alessandra A Valenti Luca L Luzi Livio L Racca Annarosa A Bandi Manuela M Tremoli Elena E Menicanti Lorenzo L Parati Gianfranco G Pompilio Giulio G

BMJ open 20230714 7

<h4>Introduction</h4>Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking.<h4>Methods and analysis</h4>The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare th ...[more]

PMID: 37451717

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Project description:BackgroundCardiovascular disease (CVD) is a major global health issue, with approximately 70% of cases linked to modifiable risk factors. Digital health solutions offer potential for CVD prevention; yet, their effectiveness in covering the full range of prevention strategies is uncertain.ObjectiveThis study aimed to synthesize current literature on digital solutions for CVD prevention, identify the key components of effective digital interventions, and highlight critical research gaps to inform the development of sustainable strategies for CVD prevention.MethodsFollowing PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we conducted a comprehensive search in Web of Science, Scopus, and PubMed to identify original English-language studies published between January 2000 and May 2024 that examined primary or secondary CVD prevention through digital solutions. The exclusion criteria included: telephone-only interventions, abstract-only publications, methodology-focused studies without primary data, studies without participants or specific groups, and studies with no follow-up period. The literature search used the string with terms like "digital health," "mHealth," "mobile health," "text message," "short message service," "SMS," "prevention," "prevent," "cardiovascular disease," "CVD," etc. Study bias was assessed using the RoB 2 (Cochrane Collaboration) and the ROBINS-I tool (Cochrane Collaboration). Data on prevention components, prevention types, study design, population, intervention, follow-up duration, personnel, and delivery settings were extracted.ResultsA total of 2871 studies were identified through the search. After excluding ineligible studies, 30 studies remained, including 24 randomized controlled trials. The reviewed digital solutions for CVD prevention focused on baseline assessment (29/30, 97%), physical activity counseling (18/30, 60%), tobacco cessation (14/30, 47%), blood pressure management (13/30, 43%), and medication adherence (10/30, 33%). The technologies used were categorized into 3 types, smartphones and wearables (16/30, 53%), email and SMS communications (12/30, 40%), and websites or web portals (3/30, 10%). The majority of the study outcomes addressed blood pressure (14/30, 47%), exercise capacity (12/30, 40%), weight (12/30, 40%), and lipid profile (11/30, 37%), while fewer focused on nicotine dependence (9/30, 30%), medication use (8/30, 27%), quality of life (7/30, 23%), dietary habits (5/30, 17%), intervention adherence (4/30, 13%), waist circumference (4/30, 13%), and blood glucose levels (2/30, 7%).ConclusionsDigital solutions can address challenges in traditional CVD prevention by improving preventive behaviors and monitoring health indicators. However, most evaluated interventions have focused on medication use, quality of life, dietary habits, adherence, and waist circumference. Further studies are needed to assess the long-term impact of more comprehensive interventions on key cardiovascular outcomes.

Project description:BackgroundObesity and depression are two prevalent conditions that are costly to individuals and society. The bidirectional association of obesity with depression, in which unhealthy dietary patterns may play an important role, has been well established. Few experimental studies have been conducted to investigate whether supplementing specific nutrients or improving diet and food-related behaviors can prevent depression in overweight persons.Method/designThe MooDFOOD prevention trial examines the feasibility and effectiveness of two different nutritional strategies [multi-nutrient supplementation and food-related behavioral change therapy (FBC)] to prevent depression in individuals who are overweight and have elevated depressive symptoms but who are not currently or in the last 6 months meeting criteria for an episode of major depressive disorder (MDD). The randomized controlled prevention trial has a two-by-two factorial design: participants are randomized to daily multi-nutrient supplement (omega-3 fatty acids, calcium, selenium, B-11 vitamin and D-3 vitamin) versus placebo, and/or FBC therapy sessions versus usual care. Interventions last 12 months. In total 1000 participants aged 18-75 years with body mass index between 25-40 kg/m(2) and with a Patient Health Questionnaire-9 score ≥ 5 will be recruited at four study sites in four European countries. Baseline and follow-up assessments take place at 0, 3, 6, and 12 months. Primary endpoint is the onset of an episode of MDD, assessed according to DSM-IV based criteria using the MINI 5.0 interview. Depressive symptoms, anxiety, food and eating behavior, physical activity and health related quality of life are secondary outcomes. During the intervention, compliance, adverse events and potentially mediating variables are carefully monitored.DiscussionThe trial aims to provide a better understanding of the causal role of specific nutrients, overall diet, and food-related behavior change with respect to the incidence of MDD episodes. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective nutritional public health strategies for the prevention of clinical depression.Trial registrationClinicalTrials.gov. Number of identification: NCT02529423 . August 2015.

Project description:BackgroundCardiovascular diseases (CVD) caused 17.9 million deaths worldwide in 2016, being the world's leading cause of death. Prevention of CVD in high-income countries is expensive and fails to reach the population at risk. In low-income countries, it is under-developed. The SPICES project implements a community-based program to improve CVD prevention in 3 European countries and 2 Sub-Saharan countries, based on using community champions to effect behavioural changes. In France, the project operates in "Pays Centre Ouest Bretagne" (COB) which is the Central West Brittany area, and a vulnerable, rural setting. The aim of this study is to assess this innovative prevention strategy versus brief advice.MethodsA two-step RCT hybrid type 1 implementation study will first of all screen a population using the Non-Laboratory INTERHEART Score (NL-IHRS) and will involve health-care students at public events in the COB area until 1000 participants have been recruited. Second, a RCT will be carried out. The research team will contact each participant with an intermediate NL-IHRS in order to include them. Participants will be over 18 years of age and work or live in the COB area. Participants will be equally randomised in two groups. The intervention group will receive brief advice plus behavioural change guidance carried out by community champions. The control group will receive brief advice only. The main objective for the RCT is to assess a difference of at least 15% in the NL-IHRS between the two groups after 24 months. The primary outcome will be analysed with intention to treat. Secondary outcomes for the RCT will be assessed using validated questionnaires: the WHOQOL-BREF, the DASH Q questionnaire, the IPAQ-short; smoking level will be assessed according to the NL-IHRS scoring system; a modified self-declared alcohol consumption questionnaire has been developed and gauges will be used to assess BMI. The implementation strategy will use mixed methods: qualitative research methods and quantitative epidemiological studies.DiscussionA difference in the mean NL-IHRS of 15% will provide an argument in favour of reorganising prevention policies. A substantial change would favour relocating primary prevention from healthcare professionals to lay people and the community.Trial registrationClinical Trials NCT03886064 - the study was recorded on ClinicalTrials.gov , the 22nd of March 2019.

Project description:IntroductionCardiovascular diseases (CVDs) are a leading cause of morbidity and mortality in low-income countries including India. There is a need for effective, low-cost methods to prevent CVDs in rural India. One strategy is to identify and implement interventions at high-risk individuals using community health workers (CHWs). There is a paucity of CHW-based CVD intervention trials from low-income countries.MethodsWe designed a multicenter, household-level, cluster-randomized trial with 1:1 allocation to intervention and control arms. The CHWs undertook a door-to-door survey and screened 5,699 households in 28 villages from 3 rural regions in India to identify at-risk households. The households were defined as those with ?1 individual aged ?35 years and at moderate or high risk for CVD based on the non-laboratory-based National Health and Nutrition Examination Survey score. All at-risk individuals were invited to attend a physician-led village clinic that provided a CVD risk reduction prescription and education about target risk factor levels for CVD control. All households in which at least 1 member at moderate to high risk for CVD had received a risk reduction prescription were eligible for randomization. Households randomized to the CHW-based intervention will receive 1 household visit by a CHW every 2 months, for 12 months. During these visits, CHWs will measure blood pressure, ascertain and reinforce adherence to prescribed therapies, and modify therapy to meet targets. Households randomized to the control arm do not receive CHW visits. At 12 months after randomization, we will evaluate 2 primary outcomes of systolic blood pressure and adherence to antihypertensive drugs and secondary outcomes of INTERHEART risk score, body mass index, and waist-to-hip ratios. At 18 to 24 months after randomization and 6 to 12 months after the last intervention, we will record these outcomes to evaluate sustainability of intervention.ResultsCommunity health workers screened a total of 5,033 households that included 9,248 individuals and identified 2,571 households with 3,784 at-risk individuals. We randomized 2,438 households (1,219 to intervention and 1,219 to control groups).ConclusionOur large trial of CHWs in rural India will provide important information regarding a promising approach to primary prevention of CVDs.

Project description:Purpose of reviewThe primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD) relies on optimizing cardiovascular health and appropriate pharmacotherapy, a mainstay of which is low-density lipoprotein-cholesterol (LDL-C) lowering. Typically, statin therapy remains the first line approach. Advances in technology and understanding of lipid metabolism have facilitated the development of several novel therapeutic targets and medications within the last decade. This review focuses on medications recently approved by the U.S. Food and Drug Administration (FDA) for the reduction of LDL-C and ASCVD risk, as well as new therapies in the pipeline.Recent findingsNovel lipid therapies aim to lower risk of ASCVD by targeting reduction of atherogenic compounds, such as LDL, lipoprotein(a) (Lp(a)), and triglyceride-rich lipoproteins. Evolocumab and alirocumab, monoclonal antibody proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors which lower LDL-C by approximately 60%, have emerged as important therapies for use in patients with ASCVD as well as familial hypercholesterolemia (FH). Bempedoic acid, an ATP citrate lyase inhibitor, is an oral medication recently approved that can lower LDL-C by approximately 18% alone and 38% when combined with ezetimibe. Inclisiran, a small-interfering RNA (siRNA) molecule which inhibits the translation of PCSK9, is the most recently FDA-approved LDL-C lowering medication, and can reduce LDL-C by approximately 50% with twice yearly subcutaneous dosing. The cardiovascular outcome trials for bempedoic acid and inclisiran are still on-going. Evinacumab, a monoclonal antibody which targets angiopoietin-like protein 3 (ANGPTL3), has been approved for use in patients with homozygous FH. SiRNAs and anti-sense oligonucleotides (ASO) facilitating selective inhibition of the production of targeted proteins including Lp(a) and ANGLPTL3 are active areas of clinical investigation.SummaryRecently several novel LDL-C lowering medications have been approved. New therapeutic targets have been identified and present additional means of lowering LDL-C and other atherogenic compounds for patients who remain at high ASCVD risk.

Dataset Information

Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention.

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