New Technologies for Intensive Prevention Programs - NET-IPP

NCT ID: NCT04143646

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 864 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2026-06-30

Brief Summary

In a randomized trial patients hospitalized for myocardial infarction are prospectively enrolled and assigned to either a web-based intensive prevention program or usual care (1 : 1 randomization). The web-based program includes telemetric transmission of data on cardiocascular risk factors (physical activity, blood pressure, body weight) by patients to the study center, e-learning modules by the study center and repetitive electronic contacts by e-mails and apps between a prevention assistant and the patient.

In addition, genetic risk on cardiovascular events will be assessed in all patients of the intervention group by a polygenetic risk score (PRS). Patients of the intervention group are randomly assigned to disclosure of genetic risk vs. no disclosure. The study hypothesis is that disclosure of genetic risk improves cardiovascular risk factor control by increased patient motivation.

Conditions

Coronary Artery Disease

Study Design

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

Study Groups

Web-based prevention program

Patients after myocardial infarction participate in a 12-months program with telemetric risk factor control, e-learning and E-Mail/App-contacts.

In a substudy patients are further randomly assigned to disclosure of genetic risk vs. no disclosure.

Group Type: ACTIVE_COMPARATOR

Web-based prevention program

Intervention Type: BEHAVIORAL

Telemetric control of risk factors, e-learning, contacts by e-mails/apps. If no response telephone calls.

In a substudy evaluation of disclosure of genetic risk.

Usual Care

Patients after myocardial infarction are treated following the standard of care (clinical practice as offered by general practitioners, cardiologists, etc.).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Web-based prevention program

Telemetric control of risk factors, e-learning, contacts by e-mails/apps. If no response telephone calls.

In a substudy evaluation of disclosure of genetic risk.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Hospitalization due to acute myocardial infarction (ST-elevation or non-ST-elevation myocardial infarction) defined according to valid international guidelines

2. Access to internet and consent to participate in a web-based prevention program

3. Consent for genetic risk assessment for cardiovascular events and risk disclosure according to randomization

Exclusion Criteria

1. Patient refusal or inability to give informed consent

2. Hemodynamically significant valvular heart disease

3. Exercise limitations due to clinical conditions not related to CAD (such as severe orthopedic disorders,..)

4. Any major non-cardiac condition that would adversely affect survival during the duration of the study (such as cancer with prognosis < 2 years,..)

5. Inability to cooperate with the protocol, including longterm follow-up

6. Chronic drug and alcohol abuse

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

Sponsors

Herzzentrum Bremen

OTHER

Sponsor Role: lead

Responsible Party

Dr. Harm Wienbergen

Head of the Bremen Institute for Heart and Circulation Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Herzzentrum Bremen

Bremen, , Germany

Countries

Germany

Other Identifiers

BIHKF 3

Identifier Type: -

Identifier Source: org_study_id