Mobile App and Digital System for Patients After Myocardial Infarction

NCT04793425 | Unknown

• 1 other identifier: WarsawMU1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Myocardial infarction; Telemedicine; Mobile health

Outcome Measures

Primary Outcomes (10)

• Rehospitalization or urgent outpatient visit

  The number and reasons of rehospitalizations and urgent outpatient visits.

  This outcome will be assessed 1 month after discharge from the hospital.

• Rehospitalization or urgent outpatient visit

  The number and reasons of rehospitalizations and urgent outpatient visits.

  This outcome will be assessed 6 months after discharge from the hospital.

• Cardiovascular risk factors control - hypertension

  Systolic and diastolic blood pressure values will be analyzed with special focus on meeting the values recommended by European Society of Cardiology guidelines.

  This outcome will be assessed 1 month after discharge from the hospital.

• Cardiovascular risk factors control - hypertension

  Systolic and diastolic blood pressure values will be analyzed with special focus on meeting the values recommended by European Society of Cardiology guidelines.

  This outcome will be assessed 6 months after discharge from the hospital.

• Cardiovascular risk factors control - body mass

  Body mass will be measured. Change \[kg\] from baseline body mass will be analyzed.

  This outcome will be assessed 1 month after discharge from the hospital.

• Cardiovascular risk factors control - body mass

  Body mass will be measured. Change \[kg\] from baseline body mass will be analyzed.

  This outcome will be assessed 6 months after discharge from the hospital.

• Cardiovascular risk factors control - nicotinism

  The number of patients who are active smokers will be assessed. The change from baseline will be analyzed.

  This outcome will be assessed 1 month after discharge from the hospital.

• Cardiovascular risk factors control - nicotinism

  The number of patients who are active smokers will be assessed. The change from baseline will be analyzed.

  This outcome will be assessed 6 months after discharge from the hospital.

• Cardiovascular risk factors control - dyslipidemia

  LDL cholesterol level will be measured and the change from baseline will be analyzed.

  This outcome will be assessed 1 month after discharge from the hospital.

• Cardiovascular risk factors control - dyslipidemia

  LDL cholesterol level will be measured and the change from baseline will be analyzed.

  This outcome will be assessed 6 months after discharge from the hospital.

Secondary Outcomes (10)

• Quality of life - MacNew

  This outcome will be assessed 1 month after discharge from the hospital.

• Quality of life - MacNew

  This outcome will be assessed 6 months after discharge from the hospital.

• Quality of life - descriptive profile of a respondent's health state

  This outcome will be assessed 1 month after discharge from the hospital.

• Quality of life - descriptive profile of a respondent's health state

  This outcome will be assessed 6 months after discharge from the hospital.

• DASS 21 - Depression, anxiety and stress assessment

  This outcome will be assessed 1 month after discharge from the hospital.

Study Arms (2)

Standard care

NO INTERVENTION

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.

Mobile app care

EXPERIMENTAL

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.

Behavioral: Mobile application (afterAMI)

Interventions

Mobile application (afterAMI) 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.

Mobile app care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

1st Department of Cariology of Medcial University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 35729626 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Bartosz Krzowski, MD

CONTACT

+48 791347820; bartosz.krzowski@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: March 11, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: March 11, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)