Clinical trial NCT04793425: Mobile App and Digital System for Patients After Myocardial Infarction
Official title: The Impact of Mobile Application and a Digital Support System on the Prevention of Cardiovascular Events in Patients After a Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: mHealth
Telemedicine
Keywords: Myocardial infarction
Telemedicine
Mobile health
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Rehospitalization or urgent outpatient visit
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: Rehospitalization or urgent outpatient visit
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
measure: Cardiovascular risk factors control - hypertension
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: Cardiovascular risk factors control - hypertension
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
measure: Cardiovascular risk factors control - body mass
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: Cardiovascular risk factors control - body mass
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
measure: Cardiovascular risk factors control - nicotinism
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: Cardiovascular risk factors control - nicotinism
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
measure: Cardiovascular risk factors control - dyslipidemia
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: Cardiovascular risk factors control - dyslipidemia
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
Secondary outcomes:
measure: Quality of life - MacNew
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: Quality of life - MacNew
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
measure: Quality of life - descriptive profile of a respondent's health state
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: Quality of life - descriptive profile of a respondent's health state
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
measure: DASS 21 - Depression, anxiety and stress assessment
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: DASS 21 - Depression, anxiety and stress assessment
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
measure: Cardiovascular risk factor knowledge
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: Cardiovascular risk factor knowledge
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
measure: Return to work
timeFrame: This outcome will be assessed 1 month after discharge from the hospital.
measure: Return to work
timeFrame: This outcome will be assessed 6 months after discharge from the hospital.
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: 1st Department of Cariology of Medcial University of Warsaw
state: Mazowieckie
Study officials:
References:
citation: 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.