Mobile App and Digital System for Patients After Myocardial Infarction (afterAMI)

• ClinicalTrials.gov Identifier: NCT04793425
• Recruitment Status: Recruiting
• First Posted: March 11, 2021
• Last Update Posted: March 11, 2021
• Sponsor: Medical University of Warsaw
• Information provided by (Responsible Party): Medical University of Warsaw

Study Description

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.

Condition or disease	Intervention/treatment	Phase
mHealth; Telemedicine	Behavioral: Mobile application (afterAMI)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Impact of Mobile Application and a Digital Support System on the Prevention of Cardiovascular Events in Patients After a Myocardial Infarction.
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Rehospitalization or urgent outpatient visit [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]
   The number and reasons of rehospitalizations and urgent outpatient visits.
2. Rehospitalization or urgent outpatient visit [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]
   The number and reasons of rehospitalizations and urgent outpatient visits.
3. Cardiovascular risk factors control - hypertension [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]
   Systolic and diastolic blood pressure values will be analyzed with special focus on meeting the values recommended by European Society of Cardiology guidelines.
4. Cardiovascular risk factors control - hypertension [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]
   Systolic and diastolic blood pressure values will be analyzed with special focus on meeting the values recommended by European Society of Cardiology guidelines.
5. Cardiovascular risk factors control - body mass [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]
   Body mass will be measured. Change [kg] from baseline body mass will be analyzed.
6. Cardiovascular risk factors control - body mass [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]
   Body mass will be measured. Change [kg] from baseline body mass will be analyzed.
7. Cardiovascular risk factors control - nicotinism [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]
   The number of patients who are active smokers will be assessed. The change from baseline will be analyzed.
8. Cardiovascular risk factors control - nicotinism [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]
   The number of patients who are active smokers will be assessed. The change from baseline will be analyzed.
9. Cardiovascular risk factors control - dyslipidemia [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]
   LDL cholesterol level will be measured and the change from baseline will be analyzed.
10. Cardiovascular risk factors control - dyslipidemia [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]
    LDL cholesterol level will be measured and the change from baseline will be analyzed.

Secondary Outcome Measures :

1. Quality of life - MacNew [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]
   Quality of life will be assessed with MacNew questionnaire.Scoring of the MacNew is straight-forward. The maximum possible score in any domain is 7 [high quality] and the minimum is 1 [poor quality]. The quality of life is assessed with regard to physical, emotional and social aspect, as well as general quality of life. There are 27 questions in total.
2. Quality of life - MacNew [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]
   Quality of life will be assessed with MacNew questionnaire.Scoring of the MacNew is straight-forward. The maximum possible score in any domain is 7 [high quality] and the minimum is 1 [poor quality]. The quality of life is assessed with regard to physical, emotional and social aspect, as well as general quality of life. There are 27 questions in total.
3. Quality of life - descriptive profile of a respondent's health state [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]

   Quality of life will be assessed with EQ-5D-5L questionnaire. The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group.

   There are 5 aspects examined: mobility, self-care, usual activity, pain/discomfort, anxiety/depression. Every part is assessed based on 5 level scale:

   LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems

4. Quality of life - descriptive profile of a respondent's health state [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]

   Quality of life will be assessed with EQ-5D-5L questionnaire. The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group.

   There are 5 aspects examined: mobility, self-care, usual activity, pain/discomfort, anxiety/depression. Every part is assessed based on 5 level scale:

   LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems

5. DASS 21 - Depression, anxiety and stress assessment [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]

   Depression, anxiety and stress assessment will be assessed with DASS 21 (Depression Anxiety Stress Scales) scale The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress.

   There are 21 questions, each has 4 possible answers:

   0 Did not apply to me at all - NEVER

   1. Applied to me to some degree, or some of the time - SOMETIMES
   2. Applied to me to a considerable degree, or a good part of time - OFTEN
   3. Applied to me very much, or most of the time - ALMOST ALWAYS There are 7 questions assigned to every aspect: depression, anxiety and stress respectively.

   Higher result in every section contributes to higher severity in depression, anxiety and stress.

6. DASS 21 - Depression, anxiety and stress assessment [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]

   Depression, anxiety and stress assessment will be assessed with DASS 21 (Depression Anxiety Stress Scales) scale The DASS is a quantitative measure of distress along the 3 axes of depression, anxiety and stress.

   There are 21 questions, each has 4 possible answers:

   0 Did not apply to me at all - NEVER

   1. Applied to me to some degree, or some of the time - SOMETIMES
   2. Applied to me to a considerable degree, or a good part of time - OFTEN
   3. Applied to me very much, or most of the time - ALMOST ALWAYS There are 7 questions assigned to every aspect: depression, anxiety and stress respectively.

   Higher result in every section contributes to higher severity in depression, anxiety and stress.

   Higher result in every section contributes to higher severity in depression, anxiety and stress.

7. Cardiovascular risk factor knowledge [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]

   Cardiovascular risk factor knowledge will be assessed with previously prepared questionnaire (10 questions).

   There are 9 single choice questions. Every correct answer is rewarded with a point. There is 1 open question, where the patient is asked to list known cardiovascular risk factors. Patient gets 1 point fo 1-2 CV risk factors, 2 points for 3-4 CV risk factors, 3 points for 5-6 CV risk factors and 4 points for >6 named CV risk factors.

   The maximum score is 13 points , which indicates good cardiovascular risk factors knowledge. The minimum score is 0 points, which indicates poor cardiovascular risk factors knowledge.

8. Cardiovascular risk factor knowledge [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]

   Cardiovascular risk factor knowledge will be assessed with previously prepared questionnaire (10 questions).

   There are 9 single choice questions. Every correct answer is rewarded with a point. There is 1 open question, where the patient is asked to list known cardiovascular risk factors. Patient gets 1 point fo 1-2 CV risk factors, 2 points for 3-4 CV risk factors, 3 points for 5-6 CV risk factors and 4 points for >6 named CV risk factors.

   The maximum score is 13 points , which indicates good cardiovascular risk factors knowledge. The minimum score is 0 points, which indicates poor cardiovascular risk factors knowledge.

9. Return to work [ Time Frame: This outcome will be assessed 1 month after discharge from the hospital. ]
   In case of patients who were previously working the amount of patients who came back to work will be assessed.
10. Return to work [ Time Frame: This outcome will be assessed 6 months after discharge from the hospital. ]
    In case of patients who were previously working the amount of patients who came back to work will be assessed.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Bartosz Krzowski, MD; +48 791347820; bartosz.krzowski@wum.edu.pl

Locations

Poland

1st Department of Cariology of Medcial University of Warsaw; Recruiting

Warsaw, Mazowieckie, Poland, 02-097

Contact: Bartosz Krzowski, MD 791347280 ext 0048 bartosz.krzowski@wum.edu.pl

Sub-Investigator: Michał Peller, PhD

Sub-Investigator: Łukasz Kołtowski, PhD

Sub-Investigator: Paweł Balsam, PhD

Sub-Investigator: Marcin D Grabowski, PhD

Principal Investigator: Bartosz Krzowski, MD

Sponsors and Collaborators

Medical University of Warsaw

More Information

• Responsible Party: Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT04793425
• Other Study ID Numbers: WarsawMU1
• First Posted: March 11, 2021
• Last Update Posted: March 11, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Warsaw:

Myocardial infarction; Telemedicine; Mobile health

Additional relevant MeSH terms:

Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases