The Effectivity of the Mobile App "HARKIT I-Care" in Secondary Prevention in Post-ACS Patients

National Cardiovascular Center Harapan Kita Hospital Indonesia

Status: Enrolling

Conditions: Acute Coronary Syndrome

Treatments: Device: HARKIT I-Care Application

Study type: Interventional

Funder types: Other

Identifiers

NCT05622292

HARKIT I-Care

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control

No Intervention group

Description:

Subjects in the control group will receive education on the day of enrolment in NCCHK. Subjects are instructed to take medications and conduct hospital visits as usual.

I-Care

Experimental group

Description:

Subjects will be instructed to download the "HARKIT I-Care" app from the google play store on their smartphones. Then, they will be guided to create an account and explained how to use the application, including how to log their progress (laboratory parameters and exercise tracking) and how to see messages from their physician. All follow-ups regarding treatment progress, education, and reminders will be done through the app. Patients are directed to conduct hospital visits once per month, where patients will be prescribed cardiovascular medications according to their current condition.

Treatment:

Device: HARKIT I-Care Application