Clinical trial NCT05782023: Secondary Cardiovascular Prevention Post-acute Myocardial Infarction (AMI) Through a Web-based Empowerment Program
Official title: Supporto Alla Prevenzione Cardiovascolare Secondaria Post-IAM Attraverso un Programma di Empowerment Web-based (PREVEN-IAM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: acute myocardial infarction
secondary prevention
atherosclerosis
health empowerment
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2023-03-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy on measurable risk factors - BMI
timeFrame: 12 months
measure: Efficacy on measurable risk factors - systolic blood pressure
timeFrame: 12 months
measure: Efficacy on measurable risk factors - diastolic blood pressure
timeFrame: 12 months
measure: Efficacy on measurable risk factors - LDL-cholesterol levels
timeFrame: 12 months
measure: Efficacy on measurable risk factors - glycemia levels
timeFrame: 12 months
measure: Efficacy on measurable risk factors - glycosylated hemoglobin in diabetic patients
timeFrame: 12 months
measure: Efficacy on measurable risk factors - expired carbon monoxide in smokers
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy on lifestyle changes - physical activity
timeFrame: 12 months
measure: Efficacy on lifestyle changes - adherence to a "heart-friendly" diet
timeFrame: 12 months
measure: Efficacy on lifestyle changes - smoking reduction or cessation
timeFrame: 12 months
measure: Efficacy on lifestyle changes - self-efficacy
timeFrame: 12 months
measure: Efficacy on lifestyle changes - Health Locus of Control
timeFrame: 12 months
measure: Efficacy on cardioprotective treatment adherence
timeFrame: 12 months
measure: Efficacy on glucose control in diabetic patients
timeFrame: 12 months
measure: Long-term maintenance of controlled levels of risk factors - BMI
timeFrame: 48 months
measure: Long-term maintenance of controlled levels of risk factors - systolic blood pressure
timeFrame: 48 months
measure: Long-term maintenance of controlled levels of risk factors - diastolic blood pressure
timeFrame: 48 months
measure: Long-term maintenance of controlled levels of risk factors - LDL cholesterol
timeFrame: 48 months
measure: Long-term maintenance of controlled levels of risk factors - glycemia levels
timeFrame: 48 months
measure: Long-term maintenance of controlled levels of risk factors - glycosylated hemoglobin in diabetic patients
timeFrame: 48 months
measure: Long-term maintenance of controlled levels of risk factors - expired carbon monoxide in smokers
timeFrame: 48 months
measure: Efficacy on secondary prevention
timeFrame: 48 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
affiliation: Centro Cardiologico Monzino
name: José P Werba, MD
role: PRINCIPAL_INVESTIGATOR
References: