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)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Behavioral: Digital empowerment

Detailed Description

The experimental intervention will consist of educational, motivational and coaching actions of patients post-AMI through a web based interaction with the prevention team. This intervention will be: 1) personalized (based on a risk factor profile obtained in-hospital) 2) agreed (planned with the patient with shared decision making), 3) multidisciplinary (physician, nutritionist, psychologist, clinical research nurse), 4) blended, composed of a minimal initial interaction face-to-face and periodical reminders (educational, motivational and supportive) for secondary prevention, through email, a reserved website and a chat box. The intervention contents, targeted at patient empowerment, will take the behavioral change models into consideration as a theoretical basis.

The participants of both groups will undergo conventional cardiology follow-up visits indicated (at 1- 3-12-36-48 months). Blood tests or any other exam other than those indicated by routine clinical practice are not required in this study. Patients with diabetes who already wear the Abbot Freestyle Libre® glucose monitoring device will be asked access to device data within two periods of two weeks, before programmed cardiology visits at 1, 3 and 12 months. At 12 months and 48 months-follow-up visits, all participants will be assessed by the Atherosclerosis Prevention Unit, and the lifestyle questionnaires administered at baseline will be repeated. The intervention group will also take a satisfaction survey at 12 months.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: José P Werba, MD; Phone Number: +39 0258002619; Email: pablo-werba@cardiologicomonzino.it

Study Locations

• Italy
  • Milan, Italy, 20138
    • Recruiting
    • Centro Cardiologico Monzino
    • Contact: José P Werba, MD; Phone Number: +39 0258002619; Email: pablo.werba@cardiologicomonzino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• STEMI or NSTEMI
• availability of digital communication devices (smart-phone, tablet or personal computer) and internet access

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital empowerment; Usual-care + preventive intervention through digital empowerment	Behavioral: Digital empowerment; 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.
No Intervention: Usual care; Usual-care (cardiologist visit at 1, 3 and 12 months after AMI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy on lifestyle changes - physical activity	Measured through the International Physical Activity Questionnaires (IPAQ). Based on the responses, three categories are identified: InactiveNo activity is reported ORSome activity is reported but not enough to meet categories 2 or 3.; Minimally ActiveAny one of the following 3 criteria:≥3 days of vigorous activity of ≥20 minutes per day OR≥5 days of moderate-intensity activity or walking of ≥30 minutes per day OR≥5 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving ≥600 MET-min/week.; HEPA (health enhancing physical activity) active Anyone of the following 2 criteria: Vigorous-intensity activity on ≥3 days and accumulating ≥1500 METminutes/week OR; ≥7 days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of ≥3000 MET-minutes/week.	12 months
Efficacy on lifestyle changes - adherence to a "heart-friendly" diet	Measured through the Mediterranean Diet Adherence Screener (MEDAS). The final MEDAS score can range between 0 and 14. To categorize the overall MEDAS score, a cut-off score of ≥8 points is used to denote adherence to the principles of the mediterranean diet, while MEDAS score of ≤7 points represents mediterranean diet non-adherence.	12 months
Efficacy on lifestyle changes - smoking reduction or cessation	Measured through the number of smoked cigarettes.	12 months
Efficacy on lifestyle changes - self-efficacy	Measured through the General Self-Efficacy Scale, GSE. It is composed of 10 items, and the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	12 months
Efficacy on lifestyle changes - Health Locus of Control	Measured through the Multidimensional Health Locus of Control (MHLC) questionnaire. The survey has 18 items with 6 items for each of its 3 subscales: Internal, Chance and Powerful Others. Each item is scored on a 6 point, Likert-type scale. The Internal subscale measures the strength of the belief that the respondent's health is the result of their own behaviors: higher scores indicate a more Internal Health Locus of Control, lower scores indicate a more External Health Locus of Control. The Powerful Others subscale measures the degree to which the respondent believes health is controlled by clinicians or a higher power. The Chance subscale indicates the degree to which the respondent believes that health is out of their control. Higher scores on both the Powerful Others and Chance subscales represent a more External Health Locus of Control while lower scores on the Powerful Others and Chance subscales indicate a more Internal Health Locus of Control.	12 months
Efficacy on cardioprotective treatment adherence	Measured through the Morisky Medication Adherence Scale (MMAS-8). The MMAS-8 range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and <6 reflecting low adherence.	12 months
Efficacy on glucose control in diabetic patients	Measured in diabetic patients who already use the continuous monitoring device Abbott Freestyle Libre® as the variation of the following parameters, to be considered 2 weeks before and after the educational intervention: mean glycemia (mg/dl); Glucose Management Indicator (GMI) (mmol/mol or %); glycemic variability (measured through the glycemic variability coefficient during monitoring, %); Time In Range (TIR) (70-180 mg/dl); High Time In Range (HTR) (>180 mg/dl); Low Time In Range (LTR) (<70 mg/dl); hyperglycemia or hypoglycemia episodes ≥15 min within the area under the curve	12 months
Long-term maintenance of controlled levels of 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).	48 months
Long-term maintenance of controlled levels of risk factors - systolic blood pressure	Measured through the changes in the systolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).	48 months
Long-term maintenance of controlled levels of risk factors - diastolic blood pressure	Measured through the changes in the diastolic blood pressure, measured in millimetres (mm) of mercury (Hg) (mmHg).	48 months
Long-term maintenance of controlled levels of risk factors - LDL cholesterol	Measured through the changes in the LDL-cholesterol levels, measured in milligrams per deciliter (mg/dL).	48 months
Long-term maintenance of controlled levels of risk factors - glycemia levels	Measured through the changes in the glycemia levels, measured in milligrams per deciliter (mg/dL).	48 months
Long-term maintenance of controlled levels of 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).	48 months
Long-term maintenance of controlled levels of 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®.	48 months
Efficacy on secondary prevention	Measured as the incidence of symptomatic coronary events (exploratory analysis).	48 months

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Collaborators: Ministry of Health, Italy
• Investigators: Principal Investigator: José P Werba, MD, Centro Cardiologico Monzino

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: atherosclerosis; acute myocardial infarction; secondary prevention; health empowerment
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: CCM 1547

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No