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

NCT ID: NCT05782023

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2025-09-30

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Digital empowerment

Usual-care + preventive intervention through digital empowerment

Group Type: EXPERIMENTAL

Digital empowerment

Intervention Type: BEHAVIORAL

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.

Usual care

Usual-care (cardiologist visit at 1, 3 and 12 months after AMI)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Italy

OTHER_GOV

Sponsor Role: collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role: lead

Responsible Party

José Pablo Werba

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José P Werba, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Cardiologico Monzino

Locations

Centro Cardiologico Monzino

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

José P Werba, MD

Role: CONTACT

pablo-werba@cardiologicomonzino.it

+39 0258002619

Facility Contacts

José P Werba, MD

Role: primary

pablo.werba@cardiologicomonzino.it

+39 0258002619

Other Identifiers

CCM 1547

Identifier Type: -

Identifier Source: org_study_id