Clinical trial NCT06882044: The Effect of a Mobile Application in Patients With Acute Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective (6-month follow-up), two-group (control and intervention), randomised controlled, experimental study
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who want to leave the study,
* Patients who do not come to their doctor's check-ups regularly.

Primary outcomes:
measure: Medication adherence
timeFrame: at 1, 3, and 6 months following their discharge
measure: Self-management
timeFrame: at 1, 3, and 6 months following their discharge
Secondary outcomes:
measure: Quality of life of individuals with Myocardial Infarction
timeFrame: at 1, 3, and 6 months following their discharge
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: Centre
Study officials:
affiliation: Trakya University
name: Eylem Paslı Gürdoğan, Ass. Prof.
role: STUDY_DIRECTOR
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