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

NCT05622292 | Unknown DMC

• 1 other identifier: HARKIT I-Care
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Mobile Health; Secondary Prevention

Outcome Measures

Primary Outcomes (4)

• Major Adverse Cardiovascular Event

  Major Adverse Cardiovascular Event (MACE) is described as all cardiovascular deaths, myocardial infarction, stroke, heart failure hospitalization, and revascularization event

  6 months

• All-Cause Mortality

  All deaths, both cardiovascular mortality and non-cardiovascular mortality

  6 months

• Cardiovascular Mortality

  We defined Cardiovascular Mortality as all deaths, excluding deaths which etiology definitely was a non-cardiovascular etiology

  6 months

• Rehospitalization

  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.

  6 months

Secondary Outcomes (17)

• Smoking Cessation

  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

• LDL Level (mg/dL)

  1, 3, and 6 months

Other Outcomes (3)

• Application Uptake

  1, 3, and 6 months

• Application Adherence

  1, 3, and 6 months

• Application Completion

  1, 3, and 6 months

Study Arms (2)

Control

NO INTERVENTION

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

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.

Device: HARKIT I-Care Application

Interventions

HARKIT I-Care Application DEVICE

HARKIT I-Care Application is an application available in the google play store. The application is specifically developed for the secondary prevention of cardiovascular disease. The features included in the application are (1) Health information logging, (2) Health information education, and (3) Teleconsultation with a cardiologist. Information that can be logged includes smoking behavior, medications, weight, blood sugar level, blood pressure, cholesterol level, physical activity, and Quality of life. Educational content can be accessed by patients in the form of articles and short videos.

I-Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita Hospital Indonesia

Jakarta, 11420, Indonesia

RECRUITING

Related Publications (5)

• 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.

  PMID: 29878099 BACKGROUND

• 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.

  PMID: 30728864 BACKGROUND

• 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.

  PMID: 26038524 BACKGROUND

• 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.

  PMID: 27895955 BACKGROUND

• 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.

  PMID: 29474713 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Bambang Dwiputra, MD, FIHA

  National Cardiovascular Center Harapan Kita

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bambang Dwiputra, MD

CONTACT

+6281371032882; bambangdwiputra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Cardiologist

Model Details: This study is a single-blind, randomized, controlled clinical trial

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 18, 2022
• Study Start: June 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)