NCT05782023

Secondary Cardiovascular Prevention Post-acute Myocardial Infarction (AMI) Through a Web-based Empowerment Program

Supporto Alla Prevenzione Cardiovascolare Secondaria Post-IAM Attraverso un Programma di Empowerment Web-based (PREVEN-IAM)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Centro Cardiologico Monzino · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-18
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-03-23
• Last updated: 2023-03-23

Locations

1 site across 1 country: Italy