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

NCT ID: NCT05622292

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a single-blind, randomized, controlled clinical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

I-Care

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.

Group Type EXPERIMENTAL

HARKIT I-Care Application

Intervention Type 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.

Interventions

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HARKIT I-Care Application

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Bambang Dwiputra, MD

MD Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bambang Dwiputra, MD, FIHA

Role: PRINCIPAL_INVESTIGATOR

National Cardiovascular Center Harapan Kita

Locations

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National Cardiovascular Center Harapan Kita Hospital Indonesia

Jakarta, , Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Bambang Dwiputra, MD

Role: CONTACT

+6281371032882

Facility Contacts

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Bambang Dwiputra, MD, FIHA

Role: primary

021-5684085 ext. 2209

Kevin Triangto, MD

Role: backup

021-5684085 ext. 2209

References

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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.

Reference Type BACKGROUND
PMID: 29878099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30728864 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26038524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27895955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29474713 (View on PubMed)

Other Identifiers

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HARKIT I-Care

Identifier Type: -

Identifier Source: org_study_id

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