mHealthafterAMINCT04793425
Mobile App and Digital System for Patients After Myocardial Infarction
A study testing Mobile application (afterAMI) in people with mHealth and Telemedicine, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- mHealth, Telemedicine
- What is being tested?
- Mobile application (afterAMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2020to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
1st Department of Cariology of Medcial University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
Bartosz Krzowski, MD, 791347280 ext. 0048, bartosz.krzowski@wum.edu.pl
Michał Peller, PhD
About this study
Official title: The Impact of Mobile Application and a Digital Support System on the Prevention of Cardiovascular Events in Patients After a Myocardial Infarction.
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.
Read more
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
- Being tested
- Mobile application (afterAMI)
- Keywords
- Myocardial infarction, Telemedicine, Mobile health
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application (afterAMI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile application (afterAMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization or urgent outpatient visit
The number and reasons of rehospitalizations and urgent outpatient visits.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This outcome will be assessed 6 months after discharge from the hospital.
Secondary outcomes (10)
Quality of life - MacNew
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.
Measured: This outcome will be assessed 1 month after discharge from the hospital.
Quality of life - MacNew
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.
Measured: This outcome will be assessed 6 months after discharge from the hospital.
Quality of life - descriptive profile of a respondent's health state
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
Measured: This outcome will be assessed 1 month after discharge from the hospital.
Quality of life - descriptive profile of a respondent's health state
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
Measured: This outcome will be assessed 6 months after discharge from the hospital.
DASS 21 - Depression, anxiety and stress assessment
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
- Applied to me to some degree, or some of the time - SOMETIMES
- Applied to me to a considerable degree, or a good part of time - OFTEN
- 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.
Measured: This outcome will be assessed 1 month after discharge from the hospital.
DASS 21 - Depression, anxiety and stress assessment
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
- Applied to me to some degree, or some of the time - SOMETIMES
- Applied to me to a considerable degree, or a good part of time - OFTEN
- 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.
Measured: This outcome will be assessed 6 months after discharge from the hospital.
Cardiovascular risk factor knowledge
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.
Measured: This outcome will be assessed 1 month after discharge from the hospital.
Cardiovascular risk factor knowledge
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.
Measured: This outcome will be assessed 6 months after discharge from the hospital.
Return to work
In case of patients who were previously working the amount of patients who came back to work will be assessed.
Measured: This outcome will be assessed 1 month after discharge from the hospital.
Return to work
In case of patients who were previously working the amount of patients who came back to work will be assessed.
Measured: This outcome will be assessed 6 months after discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Dec 2020
- Primary completionDec 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for mHealthStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793425
- Sponsor's protocol ID
- WarsawMU1
- Acronym
- afterAMI
- Status last verified
- Dec 2020
- First submitted
- 4 Feb 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35729626
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mobile Application and a Digital Support System on the Prevention of Cardiovascular Events in Patients After a Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT04793425
- Acronym / sponsor ID
- afterAMI / WarsawMU1
- Conditions
- mHealth, Telemedicine
- Keywords
- Myocardial infarction, Telemedicine, Mobile health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Mobile application (afterAMI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mobile app care |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
10 secondary outcomes
Quality of life - MacNew
Time frame: This outcome will be assessed 1 month after discharge from the hospital.
Quality of life - MacNew
Time frame: This outcome will be assessed 6 months after discharge from the hospital.
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 - descriptive profile of a respondent's health state
Time frame: This outcome will be assessed 6 months after discharge from the hospital.
DASS 21 - Depression, anxiety and stress assessment
Time frame: This outcome will be assessed 1 month after discharge from the hospital.
DASS 21 - Depression, anxiety and stress assessment
Time frame: This outcome will be assessed 6 months after discharge from the hospital.
Cardiovascular risk factor knowledge
Time frame: This outcome will be assessed 1 month after discharge from the hospital.
Cardiovascular risk factor knowledge
Time frame: This outcome will be assessed 6 months after discharge from the hospital.
Return to work
Time frame: This outcome will be assessed 1 month after discharge from the hospital.
Return to work
Time frame: This outcome will be assessed 6 months after discharge from the hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 35729626Krzowski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application (afterAMI) in people with mHealth and Telemedicine, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bartosz Krzowski, MD (+48 791347820, bartosz.krzowski@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization or urgent outpatient visit (time frame: This outcome will be assessed 1 month after discharge from the hospital.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04793425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.