Mobile App and Digital System for Patients After Myocardial Infarction

NCT ID: NCT04793425

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-07-31

Brief Summary

The treatment of acute myocardial infarction (MI) in Poland is at the level of standardized European care. However, the first months after MI are crucial from the perspective of patient's prognosis. It is extremely important to take care of all cardiovascular risk factors.

Mobile application (afterAMI) supported by web system is a novel telemedical tool created to support patient and physician during the process of cardiac rehabilitation. The application has educational model with focus on cardiovascular risk factors and lifestyle after MI. Moreover, there is a module to control vital signs like blood pressure, heart rate, weight and many others. Additionally, application will send reminders for better drug adherence.

100 patients will be recruited to take part in the study. All of which will be hospitalized at the 1st Department and Clinic of Cardiology because of the MI. The aim of the project is to study the impact of application-supported model of care with comparison to standard care. At the end of the study cardiovascular risk factors control will be analysed, as well as rehospitalizations, patient's knowledge regarding risk factors, return to work and quality of life.

This will be a prospective, open-label, randomized, single-centre study. All 100 patients will be observed 6 months after discharge from the hospital. End points will be assessed during control visit 1- and 6-months after inclusion into the study.

This project is an example of a telemedicine solution application into everyday practice, which is consistent with multiple international cardiac societies.

Conditions

mHealth; Telemedicine

Study Design

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

Study Groups

Standard care

Patients randomized to standard care arm will take part in the rehabilitation program according to regular schedule. Additionally every patient will have 2 cardiological visits: 1 and 6 months after the hospitalization due to MI.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mobile app care

Patients randomized to standard care arm will take part in the rehabilitation program according to regular schedule. Additionally every patient will have 2 cardiological visits: 1 and 6 months after the hospitalization due to MI. On top of that every patient will be given an access to mobile application, which will support rehab process. The application stands as a educational and coordination tool.

Group Type: EXPERIMENTAL

Mobile application (afterAMI)

Intervention Type: BEHAVIORAL

The rehabilitation process of the patients in the intervention group will be supported by the mobile application (afterAMI) with synchronized, dedicated web page.

Patients in the intervention group will be given an access to educational data regarding their individualized diseases. Additionally every patient will receive regularly messages with notifications regarding lifestyle and adherence to the therapy. All reported vital signs (blood pressure, heart rate, weight and many more) will be analyzed every day and in case of need a short message will be sent to the patient with indication to go to the primary healthcare clinic/hospital.

Additionally, application will send notifications with reminders to take drugs.

Interventions

Mobile application (afterAMI)

The rehabilitation process of the patients in the intervention group will be supported by the mobile application (afterAMI) with synchronized, dedicated web page.

Patients in the intervention group will be given an access to educational data regarding their individualized diseases. Additionally every patient will receive regularly messages with notifications regarding lifestyle and adherence to the therapy. All reported vital signs (blood pressure, heart rate, weight and many more) will be analyzed every day and in case of need a short message will be sent to the patient with indication to go to the primary healthcare clinic/hospital.

Additionally, application will send notifications with reminders to take drugs.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• signing the informed consent to participate in the study
• hospitalization due to myocardial infarction
• a mobile device with Internet access and the Android/iOS operating system
• age >17 years old
• positive results of the test verifying the basic skills of using mobile applications

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

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

1st Department of Cariology of Medcial University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Bartosz Krzowski, MD

Role: CONTACT

bartosz.krzowski@wum.edu.pl

+48 791347820

Facility Contacts

Bartosz Krzowski, MD

Role: primary

bartosz.krzowski@wum.edu.pl

791347280 ext. 0048

References

Krzowski B, Peller M, Boszko M, Hoffman P, Zurawska N, Jaruga K, Skoczylas K, Osak G, Koltowski L, Grabowski M, Opolski G, Balsam P. Mobile app and digital system for patients after myocardial infarction (afterAMI): study protocol for a randomized controlled trial. Trials. 2022 Jun 21;23(1):522. doi: 10.1186/s13063-022-06463-x.

Reference Type: DERIVED

PMID: 35729626 (View on PubMed)

Other Identifiers

WarsawMU1

Identifier Type: -

Identifier Source: org_study_id