The Effectivity of the Mobile App "HARKIT I-Care" in Secondary Prevention in Post Acute Coronary Syndrome Patients in National Cardiovascular Center Harapan Kita Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiovascular Event
研究概览
简要总结
HARKIT I-Care is a mobile application developed by the National Cardiovascular Center Harapan Kita (NCCHK) to leverage patients in achieving their targets for the secondary prevention of cardiovascular diseases. The application contains various features, including exercise tracking and reminder, medication reminder, and updated educational content on cardiovascular health. Additionally, patients can log and record their blood pressure, heart rate, smoking behavior, Quality of Life, and laboratory parameters such as blood sugar and cholesterol. Our research aims to investigate whether implementing this app in post-acute coronary syndrome patients could improve their survival rate, hospitalization rate, medication adherence, and Quality of Life, along with improving their laboratory parameters to be within desirable targets.
详细描述
Design: This study is a single-blinded, randomized clinical trial conducted in the National Cardiovascular Center Harapan Kita, and aims to investigate the effect of the mobile application "HARKIT I-Care" on the morbidity and mortality of post-acute coronary syndrome patients.
Subjects: Post-ACS patients hospitalized at the National Cardiovascular Center who are willing to be a subject in this research and have signed the informed consent form. Eligible subjects will be recruited and randomized to two groups: I-Care and control. Subjects in the I-Care group will be instructed to download 'HARKIT I-Care' application on their smartphone. Subjects will then be taught how to use the application, including logging blood pressure, blood sugar, and cholesterol levels, making use of exercise and medication reminders, and where to access health information and teleconsultation. Subjects are instructed to log their health parameters regularly according to the guidebook that has been prepared beforehand. Subjects in the control group will receive education on medication compliance and health information at the beginning of the enrolment. Education was conducted by another research team not involved in assessing outcomes.
Randomization: We conducted stratified permutated block random sampling using a computer application. Stratification used were: (1) Gender: male and female, (2) Age: <65 and ≥65, and (3) Diagnosis: STEMI (ST-Elevation Myocardial Infarction), NSTEMI (Non-ST-segment Elevation Myocardial Infarction), and UAP (Unstable Angina Pectoris). Randomization was conducted using a computer app, and patient assignments were done using a sealed opaque envelope containing the assignment group. Randomization was conducted by a study statistician not involved in data collection. Outcome assessors were blinded to the treatment.
Statistical Analysis plan: We planned on conducting a survival analysis for MACE (major adverse cardiovascular events), cardiovascular mortality, all-cause mortality, and rehospitalization rate. We also intended to analyze the effect of HARKIT I-Care on medication compliance, laboratory parameters, smoking cessation and relapse, sodium consumption, and physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Coronary Syndrome (ACS) patients, either ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), or unstable angina pectoris (UAP) who have or have not undergone revascularization treatment
排除标准
- •Does not have or know how to operate smartphone
- •Unable to perform a smartphone due to hearing, vision, or cognitive impairment
- •Withdrawn consent from the research
结局指标
主要结局
Major Adverse Cardiovascular Event
时间窗: 6 months
Major Adverse Cardiovascular Event (MACE) is described as all cardiovascular deaths, myocardial infarction, stroke, heart failure hospitalization, and revascularization event
All-Cause Mortality
时间窗: 6 months
All deaths, both cardiovascular mortality and non-cardiovascular mortality
Cardiovascular Mortality
时间窗: 6 months
We defined Cardiovascular Mortality as all deaths, excluding deaths which etiology definitely was a non-cardiovascular etiology
Rehospitalization
时间窗: 6 months
Rehospitalization is defined as all unplanned visits to the hospital, both to the emergency department or inpatient ward, with the diagnosis of cardiovascular diseases and related complications (bleeding, hypertension crisis, and hyperglycemia crisis). Events of the planned visit to the hospital are excluded.
次要结局
- Blood Glucose Level (mg/dL)(1, 3, and 6 months)
- Triglyceride Level (mg/dL)(1, 3, and 6 months)
- Medication Adherence(1, 3, and 6 months)
- Smoking Cessation(6 months)
- LDL Level (mg/dL)(1, 3, and 6 months)
- HbA1c (%)(1, 3, and 6 months)
- Heart Disease Fact Questionnaire (HDFQ)(1, 3, and 6 months)
- Indirect Cost(1, 3, and 6 months)
- Quality-adjusted Life Years (QALYs)(1, 3, and 6 months)
- Direct Cost(1, 3, and 6 months)
- Smoking Relapse(6 months)
- Total Cholesterol Level (mg/dL)(1, 3, and 6 months)
- HDL Level (mg/dL)(1, 3, and 6 months)
- SF-36 Quality of Life Questionnaire(1, 3, and 6 months)
- Physical activity level(1, 3, and 6 months)
- Sodium Consumption(1, 3, and 6 months)
- Cost-Utility Analysis(1, 3, and 6 months)
研究者
Bambang Dwiputra, MD
MD Cardiologist
National Cardiovascular Center Harapan Kita Hospital Indonesia