Clinical trial NCT05622292: The Effectivity of the Mobile App "HARKIT I-Care" in Secondary Prevention in Post-ACS Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Mobile Health
Secondary Prevention
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single-blind, randomized, controlled clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiovascular Event
timeFrame: 6 months
measure: All-Cause Mortality
timeFrame: 6 months
measure: Cardiovascular Mortality
timeFrame: 6 months
measure: Rehospitalization
timeFrame: 6 months
Secondary outcomes:
measure: Smoking Cessation
timeFrame: 6 months
measure: Smoking Relapse
timeFrame: 6 months
measure: Total Cholesterol Level (mg/dL)
timeFrame: 1, 3, and 6 months
measure: HDL Level (mg/dL)
timeFrame: 1, 3, and 6 months
measure: LDL Level (mg/dL)
timeFrame: 1, 3, and 6 months
measure: Triglyceride Level (mg/dL)
timeFrame: 1, 3, and 6 months
measure: Blood Glucose Level (mg/dL)
timeFrame: 1, 3, and 6 months
measure: HbA1c (%)
timeFrame: 1, 3, and 6 months
measure: SF-36 Quality of Life Questionnaire
timeFrame: 1, 3, and 6 months
measure: Physical activity level
timeFrame: 1, 3, and 6 months
measure: Medication Adherence
timeFrame: 1, 3, and 6 months
measure: Heart Disease Fact Questionnaire (HDFQ)
timeFrame: 1, 3, and 6 months
measure: Sodium Consumption
timeFrame: 1, 3, and 6 months
measure: Indirect Cost
timeFrame: 1, 3, and 6 months
measure: Quality-adjusted Life Years (QALYs)
timeFrame: 1, 3, and 6 months
measure: Cost-Utility Analysis
timeFrame: 1, 3, and 6 months
measure: Direct Cost
timeFrame: 1, 3, and 6 months
Other outcomes:
measure: Application Uptake
timeFrame: 1, 3, and 6 months
measure: Application Adherence
timeFrame: 1, 3, and 6 months
measure: Application Completion
timeFrame: 1, 3, and 6 months
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita Hospital Indonesia
Study officials:
affiliation: National Cardiovascular Center Harapan Kita
name: Bambang Dwiputra, MD, FIHA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szekely O, Lane DA, Lip GYH. Guideline-adherent secondary prevention post-acute coronary syndromes: the importance of patient uptake and persistence. Eur Heart J. 2018 Jul 1;39(25):2365-2367. doi: 10.1093/eurheartj/ehy308. No abstract available.
citation: Chow CK, Brieger D, Ryan M, Kangaharan N, Hyun KK, Briffa T. Secondary prevention therapies in acute coronary syndrome and relation to outcomes: observational study. Heart Asia. 2019 Jan 12;11(1):e011122. doi: 10.1136/heartasia-2018-011122. eCollection 2019.
citation: Mathews R, Peterson ED, Honeycutt E, Chin CT, Effron MB, Zettler M, Fonarow GC, Henry TD, Wang TY. Early Medication Nonadherence After Acute Myocardial Infarction: Insights into Actionable Opportunities From the TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circ Cardiovasc Qual Outcomes. 2015 Jul;8(4):347-56. doi: 10.1161/CIRCOUTCOMES.114.001223. Epub 2015 Jun 2.
citation: Park YT. Emerging New Era of Mobile Health Technologies. Healthc Inform Res. 2016 Oct;22(4):253-254. doi: 10.4258/hir.2016.22.4.253. Epub 2016 Oct 31. No abstract available.
citation: Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018.