Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05622292
Status:
RECRUITING
Last Update Posted:
2023-02-23
First Post:
2022-11-13
Brief Title:
The Effectivity of the Mobile App HARKIT I-Care in Secondary Prevention in Post-ACS Patients
Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Organization:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None