Italian Digital Primary Cardiovascular Prevention Study

NCT05339841 | Active Not Recruiting

• 2 other identifiers: R1256/20-CCM 1319RCR-2019-23669116_001
• Study Type: interventional
• Target: 27,520
• Locations: 1 country
• Sites: 32

Brief Summary

The CV-PREVITAL study is a randomised clinical trial (RCT) controlled versus usual-care designed to compare the effectiveness of a mobile health (mHealth) intervention with that of usual care in reducing specific cardiovascular (CV) risk factors (in the short term) and the occurrence of vascular events (in the long term). Promoted by the Italian Network of Cardiology (ICN, a cardiovascular research network promoted by the Italian Ministry of Health), in collaboration with the Consorzio Sanità (Co.S., an Italian consortium of general practitioners), CV-PREVITAL aims to develop an innovative model of cardiovascular primary prevention and to validate it in a very large sample of subjects and in 'real life' conditions.

Conditions

Healthy Population

Keywords

CV primary prevention; CV risk factors; Hypertension; Diabetes; Hypercholesterolemia; Lifestyle behaviours; Digital Health; mHealth; Mobile app; Health empowerment; Primary care

Outcome Measures

Primary Outcomes (2)

• Cardiovascular risk as assessed by Modified Moli-Sani risk score in the Italian population

  A score (modified Moli-Sani Risk Score) developed in the Italian population is used to analyze the efficacy of the intervention at 12 months. The risk score includes of blood pressure, HDL, LDL, triglyceride, blood glucose, overweight, physical activity, adhesion to Mediterranean diet and cigarette smoking. The modified Moli-Sani Risk Score may range from 0 to 100 and higher scores means higher risk. A 10% improvement in score between the baseline and final visit in the intervention group compared with the control group is assumed as indicator of intervention effectiveness.

  12 months

• Long-term CV clinical outcome at 7 years follow-up

  Incidence of a composite outcome including myocardial infarction (MI), stroke, transient ischemic attack (TIA), peripheral artery disease or CV death. In case of multiple vascular events only the first is used in the analyses of composite outcome, whereas the specific outcome (e.g. MI or stroke) is used when the sub-analyses focused on cardio- or cerebrovascular events are run.

  7 years

Secondary Outcomes (34)

• Change of a combined endpoint including hypertension, diabetes, hypercholesterolemia

  12 months

• Systolic and diastolic blood pressure (mmHg)

  12 months

• HDL-C, LDL-C, and triglycerides (mg/dL)

  12 months

• HbA1c (%)

  12 months

• Body weight (kg)

  12 months

Other Outcomes (156)

• Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in Oral Glucose Tolerance Test (OGTT) response in the CV-PREVITAL PREDIABETES sub-study cohort

  12 months

• Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in insulinemia in the CV-PREVITAL PREDIABETES sub-study cohort

  12 months

• Ancillary study of UO-1 (Centro Cardiologico Monzino IRCCS): 12-month change in high-sensitivity C-reactive protein (hs-CRP) in the CV-PREVITAL PREDIABETES sub-study cohort

  12 months

Study Arms (2)

Control group

NO INTERVENTION

Subjects monitored following usual-care.

Intervention group

EXPERIMENTAL

Subjects in the intervention group, in addition to usual-care, will download a mHealth App that contains educational information promoting healthy lifestyle behaviours. The participant will be also able to self-monitor his/her clinical status regarding hypertension, diabetes or hypercholesterolemia.

Other: Mobile health application

Interventions

Mobile health application OTHER

The mHealth app delivers a personalized support program of digital health. Specifically, using ad hoc designed algorithms which uses the data self-reported by the subject and/or collected by the recruiter at baseline, the App delivers periodic messages with advice, motivational reminders and support to improve lifestyle habits and risk factor control.

Also known as: mHealth app

Intervention group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥ 45 years
• Have given their consent to participate in the study
• Subjects who have a smartphone

You may not qualify if:

• Current or previous cardiovascular disease (personal history of myocardial infarction, angina pectoris, arterial revascularization procedures, stroke, TIA, peripheral artery disease)
• Psychiatric disorders
• Participation in other clinical trials

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Istituto Auxologico Italiano: collaborator
• Humanitas Hospital, Italy: collaborator
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator
• IRCCS Multimedica: collaborator
• Neuromed IRCCS: collaborator
• IRCCS Policlinico S. Donato: collaborator
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: collaborator
• Ospedale Policlinico San Martino: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• IRCCS San Raffaele Roma: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (32)

Nucleo Cure Primarie Val Pescara

Scafa, Abruzzo, 65027, Italy

Location

Progetto Salute Soc. Coop

Martano, Apulia, 73025, Italy

Location

Panacea Medical Group

Reggio Calabria, Calabria, 89132, Italy

Location

Samnium Medica

Benevento, Campania, 82018, Italy

Location

MEDINCO'

Salerno, Campania, 84083, Italy

Location

Magna Grecia

Salerno, Campania, 84121, Italy

Location

Meditem

Carpi, Emilia-Romagna, 41012, Italy

Location

MAF

Pradamano, Friuli Venezia Giulia, 33040, Italy

Location

IRCCS Neuromed

Pozzilli, Isernia, 86067, Italy

Location

Arvamed

Rome, Lazio, 00118, Italy

Location

IRCCS San Raffaele Roma

Rome, Lazio, 00163, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

MediCoop Genova

Genoa, Liguria, 16122, Italy

Location

Ospedale Policlinico San Martino IRCCS

Genoa, Liguria, 16132, Italy

Location

Medici Insubria

Appiano Gentile, Lombardy, 22070, Italy

Location

IML

Bergamo, Lombardy, 24121, Italy

Location

GST

Legnano, Lombardy, 20025, Italy

Location

CMMC

Milan, Lombardy, 20100, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

Centro Cardiologico Monzino

Milan, Lombardy, 20138, Italy

Location

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, 20149, Italy

Location

Cosma 2000

Mozzate, Lombardy, 22076, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Lombardy, 27100, Italy

Location

Humanitas Research Hospital IRCCS

Rozzano, Lombardy, 20089, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, Lombardy, 22097, Italy

Location

IRCCS MultiMedica SpA

Sesto San Giovanni, Lombardy, 20099, Italy

Location

CMMG Soresina

Soresina, Lombardy, 26015, Italy

Location

IRCCS Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

Palermo, Sicily, 90127, Italy

Location

ARS Medica

Seravezza, Tuscany, 55047, Italy

Location

Medici 2000

Siena, Tuscany, 53100, Italy

Location

Medigen Salute

Padua, Veneto, 35100, Italy

Location

Related Publications (1)

• Baldassarre D, Iacoviello L, Baetta R, Roncaglioni MC, Condorelli G, Remuzzi G, Gensini G, Frati L, Ricciardi W, Conaldi PG, Uccelli A, Blandini F, Bosari S, Scambia G, Fini M, Di Malta A, Amato M, Veglia F, Bonomi A, Klersy C, Colazzo F, Pengo M, Gorini F, Auteri L, Ferrante G, Baviera M, Ambrosio G, Catapano A, Gialluisi A, Malavazos AE, Castelvecchio S, Corsi-Romanelli MM, Cardani R, La Rovere MT, Agnese V, Pane B, Prati D, Spinardi L, Liuzzo G, Arbustini E, Volterrani M, Visconti M, Werba JP, Genovese S, Bilo G, Invitti C, Di Blasio A, Lombardi C, Faini A, Rosa D, Ojeda-Fernandez L, Foresta A, De Curtis A, Di Castelnuovo A, Scalvini S, Pierobon A, Gorini A, Valenti L, Luzi L, Racca A, Bandi M, Tremoli E, Menicanti L, Parati G, Pompilio G; CV-PREVITAL Study Group. Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention. BMJ Open. 2023 Jul 14;13(7):e072040. doi: 10.1136/bmjopen-2023-072040.

  PMID: 37451717 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Giulio Pompilio, Professor

  Centro Cardiologico Monzino IRCCS

  PRINCIPAL INVESTIGATOR

• Gianfranco Parati, Professor

  Istituto Auxologico Italiano IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in two parallel groups:" intervention group" and "usual care". In the setting of general medicine, the procedure randomises the general practitioners (GPs) assuring that in each recruiting centre the number of GPs assigned to the control group (usual care) is balanced with that assigned to the intervention group. In the setting of community pharmacies, the procedure randomises the pharmacies assuring that in each geographic area the number of pharmacies assigned to the control group and is balanced with that assigned to the intervention group. In the setting of IRCCS the procedure directly randomises the patients.

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: April 21, 2022
• Study Start: June 10, 2022
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

IT (32)