Secondary Cardiovascular Prevention Post-acute Myocardial Infarction (AMI) Through a Web-based Empowerment Program
PREVEN-IAM
Supporto Alla Prevenzione Cardiovascolare Secondaria Post-IAM Attraverso un Programma di Empowerment Web-based (PREVEN-IAM)
1 other identifier
interventional
400
1 country
1
Brief Summary
The aim of this study is to assess the efficacy of an innovative program of secondary cardiovascular prevention focused on patient empowerment. This program will be characterized by a blended interaction between healthcare workers and the patients: first, a face-to-face first encounter in-hospital for risk factors profiling, followed by remote interactions through a digital approach. The digital intervention is targeted at promoting the adoption and retention of virtuous behavior (e.g. smoking cessation, healthy eating habits, physical exercise, regular assumption of pharmacological therapies), improving cardiovascular risk factors control. Moreover, an exploratory endpoint will be investigated: the reduction of the residual coronary risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2022
CompletedFirst Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedMarch 23, 2023
March 1, 2023
2.9 years
February 21, 2023
March 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Efficacy on measurable risk factors - BMI
Measured through the changes in the BMI, measured in weight in kilograms divided by the square of height in meters (kg/m2).
12 months
Efficacy on measurable risk factors - systolic blood pressure
Measured through the changes in the systolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
12 months
Efficacy on measurable risk factors - diastolic blood pressure
Measured through the changes in the diastolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).
12 months
Efficacy on measurable risk factors - LDL-cholesterol levels
Measured through the changes in the LDL-cholesterol levels, measured in milligrams per deciliter (mg/dL).
12 months
Efficacy on measurable risk factors - glycemia levels
Measured through the changes in the glycemia levels, measured in milligrams per deciliter (mg/dL).
12 months
Efficacy on measurable risk factors - glycosylated hemoglobin in diabetic patients
Measured through the changes in the glycosylated hemoglobin in diabetic patients, measured in percentage (%) of glycosylated hemoglobin over total hemoglobin, or in millimole of glycated hemoglobin per mole of total hemoglobin (mmol/mol).
12 months
Efficacy on measurable risk factors - expired carbon monoxide in smokers
Measured through the changes in the expired carbon monoxide (CO) in smokers, measured in parts of expired carbon monoxide per million (ppm) per hour (ppm/h), assessed through the Smokerlyzer®.
12 months
Secondary Outcomes (15)
Efficacy on lifestyle changes - physical activity
12 months
Efficacy on lifestyle changes - adherence to a "heart-friendly" diet
12 months
Efficacy on lifestyle changes - smoking reduction or cessation
12 months
Efficacy on lifestyle changes - self-efficacy
12 months
Efficacy on lifestyle changes - Health Locus of Control
12 months
- +10 more secondary outcomes
Study Arms (2)
Digital empowerment
EXPERIMENTALUsual-care + preventive intervention through digital empowerment
Usual care
NO INTERVENTIONUsual-care (cardiologist visit at 1, 3 and 12 months after AMI)
Interventions
The intervention will consist of a minimal interaction face-to-face before hospital discharge for risk factors profiling followed by actions for health empowerment, delivered through an ad-hoc developed web platform, which include: a) periodic delivery of email messages with links to educational, motivational and supportive materials for secondary prevention, b) access to a message box for questions and answers and c) possibility of video-calls with the preventive team.
Eligibility Criteria
You may qualify if:
- STEMI or NSTEMI
- availability of digital communication devices (smart-phone, tablet or personal computer) and internet access
You may not qualify if:
- active malignancies (except for skin tumors other than melanoma)
- life expectancy \<5 years
- absolute clinical indication to undergo hospital rehabilitation cycles
- cognitive status undermining digital communication devices use, even after proper training
- low understanding of Italian language, either oral or written, by clinician's judgement
- patient not foreseeing to undergo cardiology follow-up at the site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centro Cardiologico Monzinolead
- Ministry of Health, Italycollaborator
Study Sites (1)
Centro Cardiologico Monzino
Milan, 20138, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José P Werba, MD
Centro Cardiologico Monzino
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 23, 2023
Study Start
October 18, 2022
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
March 23, 2023
Record last verified: 2023-03