Acute Myocardial Infarction (AMI)MobileappNCT06882044
The Effect of a Mobile Application in Patients With Acute Myocardial Infarction
A study testing mHealth in people with Acute Myocardial Infarction (AMI) and Mobile Health Technology (mHealth), run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Background and Aim: Acute myocardial infarction is a clinical condition with high mortality and morbidity rates. Ensuring patient adherence to treatments and lifestyle recommendations after discharge is crucial for effective post-acute myocardial infarction management. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Mobile Health Technology (mHealth), Quality of Lifte
- What is being tested?
- mHealth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 10 Jul 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had ST-segment elevation acute myocardial infarction and underwent primary percutaneous coronary intervention,
- Above the age of 18,
- Have a smart phone,
- Have internet access,
- Have orientation to place, time, and situation,
- Have no problems with vision, hearing, or speech,
- Have minimal literacy,
- Patients who volunteer to participate in the study
Who cannot join
- Patients who want to leave the study,
- Patients who do not come to their doctor's check-ups regularly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Mobile Application on Treatment Adherence, Self-Management, and Quality of Life in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Background and Aim: Acute myocardial infarction is a clinical condition with high mortality and morbidity rates. Ensuring patient adherence to treatments and lifestyle recommendations after discharge is crucial for effective post-acute myocardial infarction management. This study aimed to determine the impact of a mobile application on treatment adherence, self-management, and quality of life in patients with acute myocardial infarction undergoing primary percutaneous coronary ıntervention.
Material and Methods: This randomized controlled and experimental study was conducted between 2021 and 2024 at the cardiology clinic of a university hospital. It included patients who had their first time with ST-segment elevation acute myocardial infarction and underwent primary percutaneous coronary intervention (n=31/30).
The control group was provided standard discharge education with the "Educational Booklet for Patients Who Have Had a Heart Attack". The intervention group, in addition to these practices, mobile application support was provided. They were followed up for 6 months post-discharge. Data were collected at 1, 3 and 6 months. The patient information form including characteristics related to lifestyle changes, Medication Adherence Reporting Scale (MARS), and Myocardial Infarction Dimensional Assessment Scale (MIDAS) were used in data collection.
Read the detailed description
Aim of the study The aim of this study was to determine the effect of the mHealth on treatment adherence, and quality of life in patients with acute myocardial infarction undergoing Primary Percutaneous Coronary Intervention (PPCI).
Methods The study was a prospective (6-month follow-up), two-group (control and intervention), randomised controlled, experimental study, between 2021 and 2024.
The universe of the study consisted of patients who had their first time ST Segment Elevation Myocardial Infarction (STEMI) undergoing PPCI in the Cardiology Clinic of a university hospital in western Turkey. In determining the sample of the study, power analysis was performed with reference to the study of Turan Kavradım and Özer. The effect size of the study was found to be 0.92. Based on this effect size, it was determined that it was sufficient to include a total of 54 patients, 27 in each group, at 95% power and 0.05 significance level. However, considering a 20% loss rate during the study period, it was aimed to reach a total of 66 patients, 33 patients for each group (30). The selection of patients to the intervention and control groups was made using the simple randomization method. According to the randomization list, the groups were matched based on the time of discharge from the clinic of the patients. For patients who were discharged on the same day, the matching was based on their hospitalization times. The inclusion criteria were as follows: the patients who (i) had first time STEMI undergoing PPCI, (ii) are over 18 years of age, (iii) have a smartphone, (iv) have internet access, (v) have orientation to place, time and situation, (vi) have no problems with vision, hearing and speech, (vii) are at least literate, (viii) regularly come in for the doctor's check up, and (ix) volunteer to participate in the study. Among the volunteers participating in the study, those who wanted to leave the study (2 patients) and those who
didn't come in for the doctor's check up (3 patients) were excluded from the follow-up. Therefore, the study was completed with 61 patients, 30 in the intervention group and 31 in the control group. CONSORT flow diagram of the phases of the study is displayed in Figure 1.
Study Protocol
In the study, the control group was given a standard discharge education with an educational booklet. The intervention group was provided mHealth support, in addition to that practice. Within the scope of standard discharge education, firstly an educational booklet was developed, and this booklet was given to all patients.
Educational booklet
It was created to provide self-management in patients with AMI. During the development phase of the educational booklet, expert opinions were obtained from a total of 9 people, including 3 cardiologists, 4 academic nurses and 2 cardiology nurses, and the final version of it was created.
mHealth and web page control panel
Firstly, the content of the application was determined based on the education booklet and sample mHealth studies in the literature. In order to evaluate the content of the mHealth, expert opinions were obtained from 3 cardiologists, 4 academic nurses and 2 cardiology nurses. Then, a software company was contacted and the mHealth called "MEDIFOLL" was developed. The interface of the application includes "Medication Information", Blood P. \& Pulse", 'Notifications', 'Lifestyle' and 'Contact' sections. In the "Medication Information" section, medication entries are made. When it is time to take each medication, the mHealth sends a medication reminder notification to the user. "Blood P. \& Pulse" section includes the screen where blood pressure and pulse are entered. The "Notifications" section displays personalized reminders sent by the researcher to the users via the web page control panel. Personalized reminders are information regarding LCR which are included in the education booklet. The "Lifestyle" section contains the information contained in the booklet regarding LCR. The "Contact" section allows users to communicate with the researcher. In this way, patients can send their questions to the researcher via message. After mHealth was developed, a web page control panel was created that allows the mHealth to be controlled remotely, patient information to be viewed, data to be monitored, lifestyle information to be uploaded and
viewed in the mHealth, personalized reminders to be sent to patients, and to be communicated with patients. Additionally, the application was uploaded the Google Play Store and App Store. The mHealth and website were tested by experts for 1 week to determine usability of them and errors. Finally, a pilot study was conducted with 4 patients and the patients were allowed to use the application for a month. Patients who participated in the pilot study were not included in the study.
After the pilot study was completed, the Patient Information Form was filled out with all patients in the patient room before discharge. The researcher provided training to the patients in both groups in line with the educaiton booklet and it was delivered to the patients. MEDIFOLL application was downloaded to the mobile phones of the patients in the intervention group and user registration was made. Information was provided to them on how to use the application and how to enter data such as blood pressure and pulse rate. The times of the use of medications prescribed during discharge were planned together with the patients and they were provided with the opportunity to enter their medications into the application. Then, all patients were interviewed in the outpatient clinic at 1, 3, and 6 months following their discharge and The Patient Information Form, MARS, and MIDAS scales were filled out. The flow chart of the research is presented in Figure 2.
Data collection tool
Patient Information Form: It, developed by the researcher through a literature review, consists of questions about the socio-demographic, the lifestyle, and the disease characteristics of the participants.
Medical Adherence Report Scale (MARS): The scale was developed by Horne and Hankins to determine medication adherence in individuals with chronic diseases. The Turkish validity and reliability of the scale was performed by Şen et al. The scale has 5 items, one sub-dimension and 5-point Likert type. The total score obtained from the scale varies between 5 and 25. A high total score indicates adherence to medication treatment, while a low score indicates non-adherence to medication treatment.
Myocardial Infarction Dimensional Assessment Scale (MIDAS): The Turkish validity and reliability of the scale, developed by Thompson et al., was performed by Yılmaz et al. The scale is used to determine the HRQoL of individuals with MI and consists of 35 items and 7 sub-dimensions (physical activity, insecurity, emotional reaction, dependency, diet, concerns over medication, and medication side effects). This 5-point Likert-type scale is scored between 0-4. Scores that can be obtained from the scale and its sub-dimensions vary between 0-100. The score is calculated with the formula: (Total score obtained from the sub-dimension/highest score that can be obtained from the sub-dimension) x100. As the scores obtained from the scale increase, the perceived HRQoL worsens.
- Conditions
- Acute Myocardial Infarction (AMI), Mobile Health Technology (mHealth), Quality of Lifte, Treatment Adherence, Self Care
- Being tested
- mHealth
- Keywords
- Mobile health application, acute myocardial infarction, treatment adherence, self-care management, quality of life
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthDevice
The mobile application contains medication and personalised reminders, the screen where blood pressure and pulse are entered, the lifestyle change recommendations information, and the section that allows users to communicate with the researcher. Also, there is a control panel that allows the application to be controlled remotely, patient information to be viewed, data to be monitored, lifestyle information to be uploaded and viewed in the mHealth, personalised reminders to be sent to patients, and communication with patients.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Group receiving standard discharge education with 'Educational Booklet for Patients Who Have Had a Heart Attack' |
| Intervention group | Experimental | Group receiving standard discharge education with 'Educational Booklet for Patients Who Have Had a Heart Attack' and using Mobile Health Application (mHealth) Receives: Device: mHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication Adherence Report Scale: The total score obtained from the scale varies between 5 and 25. A high total score indicates adherence to medication treatment, while a low score indicates non-adherence to medication treatment.
Measured: at 1, 3, and 6 months following their discharge
Self-management
This title contains adherence of individuals to lifestyle change recommendations. The questions in this section are: Status of smoking, status of regular physical activity/exercise (>150 min/week), status of consumption of fruit and vegetables per ≥5 days a week and status of consumption of <500 g of red meat per week.
Measured: at 1, 3, and 6 months following their discharge
Secondary outcomes (1)
Quality of life of individuals with Myocardial Infarction
Myocardial Infarction Dimensional Assessment Scale (MIDAS): The scale is used to determine the quality of life of individuals with Myocardial Infarction. Scores that can be obtained from the scale and its sub-dimensions vary between 0-100. As the scores obtained from the scale increase, the perceived quality of life worsens.
Measured: at 1, 3, and 6 months following their discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Nov 2021
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective (6-month follow-up), two-group (control and intervention), randomised controlled, experimental study
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Kınıcı Dirik, Trakya University
- Investigators
- Eylem Paslı Gürdoğan, Ass. Prof., Study director, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882044
- Sponsor's protocol ID
- TÜTF-BAEK 2021/283
- Other IDs
- There is no funding support
- Acronym
- Mobileapp
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harbi AS, Soh KL, Yubbu PB, Soh KG. The impact of cardiac rehabilitation on psychosocial factors, functional capacity, and left ventricular function in patients with coronary artery disease: Systematic review and meta-analysis. F1000Research. 2024;13:575
Delgado-Lista J, Alcala-Diaz JF, Torres-Pena JD, Quintana-Navarro GM, Fuentes F, Garcia-Rios A, Ortiz-Morales AM, Gonzalez-Requero AI, Perez-Caballero AI, Yubero-Serrano EM, Rangel-Zuniga OA, Camargo A, Rodriguez-Cantalejo F, Lopez-Segura F, Badimon L, Ordovas JM, Perez-Jimenez F, Perez-Martinez P, Lopez-Miranda J; CORDIOPREV Investigators. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial. Lancet. 2022 May 14;399(10338):1876-1885. doi: 10.1016/S0140-6736(22)00122-2. Epub 2022 May 4.
PubMed 35525255Berg E, Agewall S, Brolin EB, Caidahl K, Cederlund K, Collste O, Daniel M, Ekenback C, Jensen J, Y-Hassan S, Henareh L, Maret E, Spaak J, Sorensson P, Tornvall P, Lynga P. Health-related quality-of-life up to one year after myocardial infarction with non-obstructive coronary arteries. Eur Heart J Qual Care Clin Outcomes. 2023 Sep 12;9(6):639-644. doi: 10.1093/ehjqcco/qcac072.
PubMed 36328780Lao SSW, Chair SY, Wang Q, Leong MLT. The Feasibility and Effects of Smartphone-Based Application on Cardiac Rehabilitation for Patients After Percutaneous Coronary Intervention: A Randomized Controlled Trial. J Cardiovasc Nurs. 2024 Jan-Feb 01;39(1):88-101. doi: 10.1097/JCN.0000000000000993. Epub 2023 May 11.
PubMed 37088896Lizcano-Alvarez A, Carretero-Julian L, Talavera-Saez A, Cristobal-Zarate B, Cid-Exposito MG, Alameda-Cuesta A; REccAP Group (Red de Enfermeria de Cuidados Cardiovasculares en Atencion Primaria). Intensive nurse-led follow-up in primary care to improve self-management and compliance behaviour after myocardial infarction. Nurs Open. 2023 Aug;10(8):5211-5224. doi: 10.1002/nop2.1758. Epub 2023 Apr 21.
PubMed 37084014Bhagavathula AS, Aldhaleei WA, Atey TM, Assefa S, Tesfaye W. Efficacy of eHealth Technologies on Medication Adherence in Patients With Acute Coronary Syndrome: Systematic Review and Meta-Analysis. JMIR Cardio. 2023 Dec 19;7:e52697. doi: 10.2196/52697.
PubMed 38113072Krackhardt F, Jornten-Karlsson M, Waliszewski M, Knutsson M, Niklasson A, Appel KF, Degenhardt R, Ghanem A, Kohler T, Ohlow MA, Tschope C, Theres H, Vom Dahl J, Karlson BW, Maier LS. Results from the "Me & My Heart" (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome. Cardiovasc Drugs Ther. 2023 Aug;37(4):729-741. doi: 10.1007/s10557-022-07331-1. Epub 2022 Apr 20.
PubMed 35441926Bernal-Jimenez MA, Calle G, Gutierrez Barrios A, Gheorghe LL, Cruz-Cobo C, Trujillo-Garrido N, Rodriguez-Martin A, Tur JA, Vazquez-Garcia R, Santi-Cano MJ. Effectiveness of an Interactive mHealth App (EVITE) in Improving Lifestyle After a Coronary Event: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Apr 22;12:e48756. doi: 10.2196/48756.
PubMed 38648103Yilmaz E, Eser E, Sekuri C, Kultursay H. [The psychometric properties of the Turkish version of Myocardial Infarction Dimensional Assessment Scale (MIDAS)]. Anadolu Kardiyol Derg. 2011 Aug;11(5):386-401. doi: 10.5152/akd.2011.105. Epub 2011 Jun 7. Turkish.
PubMed 21652294Cruz-Cobo C, Bernal-Jimenez MA, Calle G, Gheorghe LL, Gutierrez-Barrios A, Canadas D, Tur JA, Vazquez-Garcia R, Santi-Cano MJ. Efficacy of a Mobile Health App (eMOTIVA) Regarding Compliance With Cardiac Rehabilitation Guidelines in Patients With Coronary Artery Disease: Randomized Controlled Clinical Trial. JMIR Mhealth Uhealth. 2024 Jul 25;12:e55421. doi: 10.2196/55421.
PubMed 39052330Turan Kavradim S, Canli Ozer Z. The effect of education and telephone follow-up intervention based on the Roy Adaptation Model after myocardial infarction: randomised controlled trial. Scand J Caring Sci. 2020 Mar;34(1):247-260. doi: 10.1111/scs.12793. Epub 2019 Nov 26.
PubMed 31769891Pietrzykowski L, Michalski P, Kosobucka A, Kasprzak M, Fabiszak T, Stolarek W, Siller-Matula JM, Kubica A. Medication adherence and its determinants in patients after myocardial infarction. Sci Rep. 2020 Jul 21;10(1):12028. doi: 10.1038/s41598-020-68915-1.
PubMed 32694522Varnfield M, Karunanithi M, Lee CK, Honeyman E, Arnold D, Ding H, Smith C, Walters DL. Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial. Heart. 2014 Nov;100(22):1770-9. doi: 10.1136/heartjnl-2014-305783. Epub 2014 Jun 27.
PubMed 24973083Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.
PubMed 27222591Gonzalez M, Sjolin I, Back M, Ogmundsdottir Michelsen H, Tanha T, Sandberg C, Schiopu A, Leosdottir M. Effect of a lifestyle-focused electronic patient support application for improving risk factor management, self-rated health, and prognosis in post-myocardial infarction patients: study protocol for a multi-center randomized controlled trial. Trials. 2019 Jan 24;20(1):76. doi: 10.1186/s13063-018-3118-1.
PubMed 30678709
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Mobile Application on Treatment Adherence, Self-Management, and Quality of Life in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06882044
- Acronym / sponsor ID
- Mobileapp / TÜTF-BAEK 2021/283
- Conditions
- Acute Myocardial Infarction (AMI), Mobile Health Technology (mHealth), Quality of Lifte, Treatment Adherence, Self Care
- Keywords
- Mobile health application, acute myocardial infarction, treatment adherence, self-care management, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 18 Mar 2025 (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.
Background and Aim: Acute myocardial infarction is a clinical condition with high mortality and morbidity rates. Ensuring patient adherence to treatments and lifestyle recommendations after discharge is crucial for effective post-acute myocardial infarction management. This study aimed to determine the impact of a mobile application on treatment adherence, self-management, and quality of life in patients with acute myocardial infarction undergoing primary percutaneous coronary ıntervention.
Material and Methods: This randomized controlled and experimental study was conducted between 2021 and 2024 at the cardiology clinic of a university hospital. It included patients who had their first time with ST-segment elevation acute myocardial infarction and underwent primary percutaneous coronary intervention (n=31/30).
The control group was provided standard discharge education with the "Educational Booklet for Patients Who Have Had a Heart Attack". The intervention group, in addition to these practices, mobile application support was provided. They were followed up for 6 months post-discharge. Data were collected at 1, 3 and 6 months. The patient information form including characteristics related to lifestyle changes, Medication Adherence Reporting Scale (MARS), and Myocardial Infarction Dimensional Assessment Scale (MIDAS) were used in data collection.
Detailed description
Aim of the study The aim of this study was to determine the effect of the mHealth on treatment adherence, and quality of life in patients with acute myocardial infarction undergoing Primary Percutaneous Coronary Intervention (PPCI).
Methods The study was a prospective (6-month follow-up), two-group (control and intervention), randomised controlled, experimental study, between 2021 and 2024.
The universe of the study consisted of patients who had their first time ST Segment Elevation Myocardial Infarction (STEMI) undergoing PPCI in the Cardiology Clinic of a university hospital in western Turkey. In determining the sample of the study, power analysis was performed with reference to the study of Turan Kavradım and Özer. The effect size of the study was found to be 0.92. Based on this effect size, it was determined that it was sufficient to include a total of 54 patients, 27 in each group, at 95% power and 0.05 significance level. However, considering a 20% loss rate during the study period, it was aimed to reach a total of 66 patients, 33 patients for each group (30). The selection of patients to the intervention and control groups was made using the simple randomization method. According to the randomization list, the groups were matched based on the time of discharge from the clinic of the patients. For patients who were discharged on the same day, the matching was based on their hospitalization times. The inclusion criteria were as follows: the patients who (i) had first time STEMI undergoing PPCI, (ii) are over 18 years of age, (iii) have a smartphone, (iv) have internet access, (v) have orientation to place, time and situation, (vi) have no problems with vision, hearing and speech, (vii) are at least literate, (viii) regularly come in for the doctor's check up, and (ix) volunteer to participate in the study. Among the volunteers participating in the study, those who wanted to leave the study (2 patients) and those who
didn't come in for the doctor's check up (3 patients) were excluded from the follow-up. Therefore, the study was completed with 61 patients, 30 in the intervention group and 31 in the control group. CONSORT flow diagram of the phases of the study is displayed in Figure 1.
Study Protocol
In the study, the control group was given a standard discharge education with an educational booklet. The intervention group was provided mHealth support, in addition to that practice. Within the scope of standard discharge education, firstly an educational booklet was developed, and this booklet was given to all patients.
Educational booklet
It was created to provide self-management in patients with AMI. During the development phase of the educational booklet, expert opinions were obtained from a total of 9 people, including 3 cardiologists, 4 academic nurses and 2 cardiology nurses, and the final version of it was created.
mHealth and web page control panel
Firstly, the content of the application was determined based on the education booklet and sample mHealth studies in the literature. In order to evaluate the content of the mHealth, expert opinions were obtained from 3 cardiologists, 4 academic nurses and 2 cardiology nurses. Then, a software company was contacted and the mHealth called "MEDIFOLL" was developed. The interface of the application includes "Medication Information", Blood P. \& Pulse", 'Notifications', 'Lifestyle' and 'Contact' sections. In the "Medication Information" section, medication entries are made. When it is time to take each medication, the mHealth sends a medication reminder notification to the user. "Blood P. \& Pulse" section includes the screen where blood pressure and pulse are entered. The "Notifications" section displays personalized reminders sent by the researcher to the users via the web page control panel. Personalized reminders are information regarding LCR which are included in the education booklet. The "Lifestyle" section contains the information contained in the booklet regarding LCR. The "Contact" section allows users to communicate with the researcher. In this way, patients can send their questions to the researcher via message. After mHealth was developed, a web page control panel was created that allows the mHealth to be controlled remotely, patient information to be viewed, data to be monitored, lifestyle information to be uploaded and
viewed in the mHealth, personalized reminders to be sent to patients, and to be communicated with patients. Additionally, the application was uploaded the Google Play Store and App Store. The mHealth and website were tested by experts for 1 week to determine usability of them and errors. Finally, a pilot study was conducted with 4 patients and the patients were allowed to use the application for a month. Patients who participated in the pilot study were not included in the study.
After the pilot study was completed, the Patient Information Form was filled out with all patients in the patient room before discharge. The researcher provided training to the patients in both groups in line with the educaiton booklet and it was delivered to the patients. MEDIFOLL application was downloaded to the mobile phones of the patients in the intervention group and user registration was made. Information was provided to them on how to use the application and how to enter data such as blood pressure and pulse rate. The times of the use of medications prescribed during discharge were planned together with the patients and they were provided with the opportunity to enter their medications into the application. Then, all patients were interviewed in the outpatient clinic at 1, 3, and 6 months following their discharge and The Patient Information Form, MARS, and MIDAS scales were filled out. The flow chart of the research is presented in Figure 2.
Data collection tool
Patient Information Form: It, developed by the researcher through a literature review, consists of questions about the socio-demographic, the lifestyle, and the disease characteristics of the participants.
Medical Adherence Report Scale (MARS): The scale was developed by Horne and Hankins to determine medication adherence in individuals with chronic diseases. The Turkish validity and reliability of the scale was performed by Şen et al. The scale has 5 items, one sub-dimension and 5-point Likert type. The total score obtained from the scale varies between 5 and 25. A high total score indicates adherence to medication treatment, while a low score indicates non-adherence to medication treatment.
Myocardial Infarction Dimensional Assessment Scale (MIDAS): The Turkish validity and reliability of the scale, developed by Thompson et al., was performed by Yılmaz et al. The scale is used to determine the HRQoL of individuals with MI and consists of 35 items and 7 sub-dimensions (physical activity, insecurity, emotional reaction, dependency, diet, concerns over medication, and medication side effects). This 5-point Likert-type scale is scored between 0-4. Scores that can be obtained from the scale and its sub-dimensions vary between 0-100. The score is calculated with the formula: (Total score obtained from the sub-dimension/highest score that can be obtained from the sub-dimension) x100. As the scores obtained from the scale increase, the perceived HRQoL worsens.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective (6-month follow-up), two-group (control and intervention), randomised controlled, experimental study
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Group receiving standard discharge education with 'Educational Booklet for Patients Who Have Had a Heart Attack' |
| Intervention group | Experimental | Device: mHealthGroup receiving standard discharge education with 'Educational Booklet for Patients Who Have Had a Heart Attack' and using Mobile Health Application (mHealth) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who had ST-segment elevation acute myocardial infarction and underwent primary percutaneous coronary intervention,
- Above the age of 18,
- Have a smart phone,
- Have internet access,
- Have orientation to place, time, and situation,
Key exclusion criteria (2 listed)
- Patients who want to leave the study,
- Patients who do not come to their doctor's check-ups regularly.
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 |
|---|---|---|
| mHealthThe mobile application contains medication and personalised reminders, the screen where blood pressure and pulse are entered, the lifestyle change recommendations information, and the section that allows users to communicate with the researcher. Also, there is a control panel that allows the application to be controlled remotely, patient information to be viewed, data to be monitored, lifestyle information to be uploaded and viewed in the mHealth, personalised reminders to be sent to patients, and communication with patients. | Device | Intervention group |
Primary outcome
Medication adherence
Time frame: at 1, 3, and 6 months following their discharge
Medication Adherence Report Scale: The total score obtained from the scale varies between 5 and 25. A high total score indicates adherence to medication treatment, while a low score indicates non-adherence to medication treatment.
Self-management
Time frame: at 1, 3, and 6 months following their discharge
This title contains adherence of individuals to lifestyle change recommendations. The questions in this section are: Status of smoking, status of regular physical activity/exercise (>150 min/week), status of consumption of fruit and vegetables per ≥5 days a week and status of consumption of <500 g of red meat per week.
1 secondary outcome
Quality of life of individuals with Myocardial Infarction
Time frame: at 1, 3, and 6 months following their discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- BackgroundHarbi AS, Soh KL, Yubbu PB, Soh KG. The impact of cardiac rehabilitation on psychosocial factors, functional capacity, and left ventricular function in patients with coronary artery disease: Systematic review and meta-analysis. F1000Research. 2024;13:575
- Background: PubMed 35525255Delgado-Lista J, Alcala-Diaz JF, Torres-Pena JD, Quintana-Navarro GM, Fuentes F, Garcia-Rios A, Ortiz-Morales AM, Gonzalez-Requero AI, Perez-Caballero AI, Yubero-Serrano EM, Rangel-Zuniga OA, Camargo A, Rodriguez-Cantalejo F, Lopez-Segura F, Badimon L, Ordovas JM, Perez-Jimenez F, Perez-Martinez P, Lopez-Miranda J; CORDIOPREV Investigators. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial. Lancet. 2022 May 14;399(10338):1876-1885. doi: 10.1016/S0140-6736(22)00122-2. Epub 2022 May 4.
- Background: PubMed 36328780Berg E, Agewall S, Brolin EB, Caidahl K, Cederlund K, Collste O, Daniel M, Ekenback C, Jensen J, Y-Hassan S, Henareh L, Maret E, Spaak J, Sorensson P, Tornvall P, Lynga P. Health-related quality-of-life up to one year after myocardial infarction with non-obstructive coronary arteries. Eur Heart J Qual Care Clin Outcomes. 2023 Sep 12;9(6):639-644. doi: 10.1093/ehjqcco/qcac072.
- Background: PubMed 37088896Lao SSW, Chair SY, Wang Q, Leong MLT. The Feasibility and Effects of Smartphone-Based Application on Cardiac Rehabilitation for Patients After Percutaneous Coronary Intervention: A Randomized Controlled Trial. J Cardiovasc Nurs. 2024 Jan-Feb 01;39(1):88-101. doi: 10.1097/JCN.0000000000000993. Epub 2023 May 11.
- Background: PubMed 37084014Lizcano-Alvarez A, Carretero-Julian L, Talavera-Saez A, Cristobal-Zarate B, Cid-Exposito MG, Alameda-Cuesta A; REccAP Group (Red de Enfermeria de Cuidados Cardiovasculares en Atencion Primaria). Intensive nurse-led follow-up in primary care to improve self-management and compliance behaviour after myocardial infarction. Nurs Open. 2023 Aug;10(8):5211-5224. doi: 10.1002/nop2.1758. Epub 2023 Apr 21.
- Background: PubMed 38113072Bhagavathula AS, Aldhaleei WA, Atey TM, Assefa S, Tesfaye W. Efficacy of eHealth Technologies on Medication Adherence in Patients With Acute Coronary Syndrome: Systematic Review and Meta-Analysis. JMIR Cardio. 2023 Dec 19;7:e52697. doi: 10.2196/52697.
- Background: PubMed 35441926Krackhardt F, Jornten-Karlsson M, Waliszewski M, Knutsson M, Niklasson A, Appel KF, Degenhardt R, Ghanem A, Kohler T, Ohlow MA, Tschope C, Theres H, Vom Dahl J, Karlson BW, Maier LS. Results from the "Me & My Heart" (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome. Cardiovasc Drugs Ther. 2023 Aug;37(4):729-741. doi: 10.1007/s10557-022-07331-1. Epub 2022 Apr 20.
- Background: PubMed 38648103Bernal-Jimenez MA, Calle G, Gutierrez Barrios A, Gheorghe LL, Cruz-Cobo C, Trujillo-Garrido N, Rodriguez-Martin A, Tur JA, Vazquez-Garcia R, Santi-Cano MJ. Effectiveness of an Interactive mHealth App (EVITE) in Improving Lifestyle After a Coronary Event: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Apr 22;12:e48756. doi: 10.2196/48756.
- Background: PubMed 21652294Yilmaz E, Eser E, Sekuri C, Kultursay H. [The psychometric properties of the Turkish version of Myocardial Infarction Dimensional Assessment Scale (MIDAS)]. Anadolu Kardiyol Derg. 2011 Aug;11(5):386-401. doi: 10.5152/akd.2011.105. Epub 2011 Jun 7. Turkish.
- Background: PubMed 39052330Cruz-Cobo C, Bernal-Jimenez MA, Calle G, Gheorghe LL, Gutierrez-Barrios A, Canadas D, Tur JA, Vazquez-Garcia R, Santi-Cano MJ. Efficacy of a Mobile Health App (eMOTIVA) Regarding Compliance With Cardiac Rehabilitation Guidelines in Patients With Coronary Artery Disease: Randomized Controlled Clinical Trial. JMIR Mhealth Uhealth. 2024 Jul 25;12:e55421. doi: 10.2196/55421.
- Background: PubMed 31769891Turan Kavradim S, Canli Ozer Z. The effect of education and telephone follow-up intervention based on the Roy Adaptation Model after myocardial infarction: randomised controlled trial. Scand J Caring Sci. 2020 Mar;34(1):247-260. doi: 10.1111/scs.12793. Epub 2019 Nov 26.
- Background: PubMed 32694522Pietrzykowski L, Michalski P, Kosobucka A, Kasprzak M, Fabiszak T, Stolarek W, Siller-Matula JM, Kubica A. Medication adherence and its determinants in patients after myocardial infarction. Sci Rep. 2020 Jul 21;10(1):12028. doi: 10.1038/s41598-020-68915-1.
- WHO. The top 10 causes of deathLink provided by the sponsor.
- WHO. Cardiovascular diseases (CVDs)Link provided by the sponsor.
- WHO. Sodium reductionLink provided by the sponsor.
- Hambraeus K, Hagström E, Leosdottir M. SEPHIA- Secondary prevention following coronary intensive care. SWEDEHEART Annual report 2016Link provided by the sponsor.
- 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.
Eylem Paslı Gürdoğan, Ass. Prof. study director
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth in people with Acute Myocardial Infarction (AMI) and Mobile Health Technology (mHealth), run by Trakya University at 1 site in Turkey (Türkiye).
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 18 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: at 1, 3, and 6 months following their discharge). The study lists 2 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 NCT06882044, which also lists 27 linked publications.
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 18 Mar 2025.