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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Medication adherence
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who want to leave the study,
- •Patients who do not come to their doctor's check-ups regularly.
研究组 & 干预措施
Control Group
Group receiving standard discharge education with 'Educational Booklet for Patients Who Have Had a Heart Attack'
Intervention group
Group receiving standard discharge education with 'Educational Booklet for Patients Who Have Had a Heart Attack' and using Mobile Health Application (mHealth)
干预措施: mHealth (Device)
结局指标
主要结局
Medication adherence
时间窗: 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
时间窗: 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.
次要结局
- Quality of life of individuals with Myocardial Infarction(at 1, 3, and 6 months following their discharge)
研究者
Ezgi Kınıcı Dirik
Principal Investigator
Trakya University