GeriKit App for Ischemic Heart Disease

Overseen By Michelle Rojas

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Non-ambulatory, Dementia, Incarcerated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This study seeks to expand the use of the NYU GeriKit mobile application ("app") in a diverse range of settings to better phenotype older patients, which will enhance both research and patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the GeriKit App treatment for ischemic heart disease?

Research shows that mobile apps can help people with heart conditions stick to their medication and make healthier lifestyle choices. In one study, patients using a mobile app after heart procedures had better medication compliance and fewer adverse events compared to those who didn't use the app. ^{1 2 3 4 5}

How does the GeriKit App treatment for ischemic heart disease differ from other treatments?

The GeriKit App is unique because it likely involves a digital or software-based approach to managing ischemic heart disease, which is different from traditional drug or surgical treatments. This app may offer novel ways to monitor and manage heart health through technology, potentially providing real-time data and personalized insights for patients. ^{6 7 8 9 10}

Research Team

John Dodson, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals aged 75 or older who are currently hospitalized or were hospitalized within the past month for heart-related procedures like AMI, PCI, or CABG. Participants must be able to consent and perform study tasks in English. Those with severe cognitive issues, non-ambulatory status, incarceration, or inability to complete assessments in English cannot join.

Inclusion Criteria

I am able to understand and agree to the study on my own.

I am in the hospital or was recently hospitalized for a heart attack or heart surgery.

Understand and are able to perform study procedures in English

Exclusion Criteria

Unable or unwilling to consent

Currently in prison.

I have been diagnosed with dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants receive comprehensive geriatric assessment via GeriKit app

1 day

1 visit (in-person)

Follow-up

Participants complete a follow-up assessment via phone

6 months

1 visit (virtual)

Qualitative Questionnaire

20 participants complete a qualitative questionnaire after the 6-month follow-up

1 day

1 visit (virtual)

Treatment Details

Interventions

• GeriKit Mobile Application

Trial Overview The trial is testing the GeriKit mobile application's effectiveness in assessing older adults with ischemic heart disease. The goal is to improve patient care and research by better understanding this population through the app's use.

Participant Groups

Group I: Geriatric Assessments using GeriKit App Experimental Treatment 1 Intervention

Participants will receive comprehensive geriatric assessment via GeriKit app at baseline. All participants will complete a follow-up assessment via phone at 6 months. 20 of the 150 enrolled participants will continue onto a qualitative questionnaire after the completion of the 6-month follow up call.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The use of an interactive smartphone application significantly improved drug adherence among myocardial infarction patients, with a nonadherence score of 16.6 in the active group compared to 22.8 in the control group after 6 months (P = .025).

Patients using the app reported higher satisfaction with the tool (system usability score of 87.3 vs 78.1, P = .001) and showed trends towards better cardiovascular lifestyle changes, although these did not reach statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of interactive patient smartphone support app on drug adherence and lifestyle changes in myocardial infarction patients: A randomized study. Johnston, N., Bodegard, J., Jerström, S., et al.[2018]

A study involving 200 ischemic heart disease patients showed that using a mobile application significantly improved medication compliance compared to a control group that received only telephonic follow-ups.

Patients using the mobile app experienced fewer adverse events and maintained regular follow-ups, highlighting the app's potential to enhance patient management after percutaneous transluminal coronary angioplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mobile application-based technology use on medication compliance and modification of risk factors in post PTCA cohort of patients. Devaraju, CJ., Veena, N., Sadananda, KS., et al.[2022]

The 'Korea University Health Monitoring System for Stroke' app was tested on 48 stroke patients over a 6-month period, showing significant improvements in managing vascular risk factors like blood pressure and glycated hemoglobin (Hb(A1c)).

Despite challenges in implementation, the app demonstrated feasibility by achieving a mean of 60 days of data registration per patient, indicating its potential to positively influence health management in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using a mobile application for the monitoring and management of stroke-associated risk factors. Seo, WK., Kang, J., Jeon, M., et al.[2022]

The study will evaluate the effectiveness of the 'afterAMI' mobile application in supporting the rehabilitation of 100 patients after myocardial infarction over a 6-month period, comparing it to standard rehabilitation methods.

The app includes features like medication reminders and a vital signs diary, which have individually shown promise in improving patient outcomes, but this study aims to provide comprehensive evidence on their collective impact in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile app and digital system for patients after myocardial infarction (afterAMI): study protocol for a randomized controlled trial. Krzowski, B., Peller, M., Boszko, M., et al.[2022]

A smartphone-guided training system (GEX) for cardiac rehabilitation (CR) was found to be feasible and safe, with no training-related complications reported during the study involving 118 patients with coronary artery disease.

Patients using the GEX system showed a significant improvement in exercise capacity (peak VO2) compared to those receiving conventional CR, indicating that remote monitoring can enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based training of coronary artery patients: the Heart Cycle Trial. Skobel, E., Knackstedt, C., Martinez-Romero, A., et al.[2022]

The analysis utilized data from a longitudinal study involving 1417 men aged 40 to 50 years, demonstrating the effectiveness of new software tools in processing cardiology data.

The HYPERTENSION program was specifically highlighted for its role in aiding decision-making for the treatment of arterial hypertension, showcasing its potential clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of data in cardiology by new software tools. Zvarova, J., Tomeskova, M., Boudik, F., et al.[2015]

In patients with coronary artery disease, angina pectoris does not reliably indicate the severity of the disease, as many experience asymptomatic episodes of ischemia that can lead to serious events like heart attacks and sudden death.

Research suggests that assessing the 'total ischemic burden'—which includes both painful and painless ischemic episodes—could become crucial in evaluating disease activity and guiding treatment, potentially improving patient outcomes in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total ischemic burden in patients with coronary artery disease. Deanfield, JE.[2019]

Ischemic preconditioning (IPC) can protect the heart from longer ischemic events, and while its exact mechanism is not fully understood, it may involve ATP preservation or recruitment of collateral blood vessels.

This case report provides visual evidence of IPC using an 80 Lead ECG device, which can map the heart's electrical activity in 3D and detect ischemic changes, highlighting its potential utility in evaluating ischemic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual Evidence of Ischemic Preconditioning During PCI Using 80 Lead ECG Body Surface Mapping. Dadkhah, S., Dowlatshahi, S., Sharain, K., et al.[2021]

The semiautomated ECG analysis program improves the accuracy and reproducibility of detecting myocardial ischemia during exercise tests, making it a valuable tool for clinical assessments.

This program is efficient and suitable for analyzing large volumes of exercise ECG data in multicenter clinical trials, as evidenced by its use in significant studies like TIMI II, TIMI III, and BARI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of computerized exercise ECG digitization. Interpretation in large clinical trials. Caralis, DG., Shaw, L., Bilgere, B., et al.[2022]

Exercise-induced myocardial ischemia, even without angina, is linked to a poor prognosis in patients with angina pectoris, highlighting the need for careful monitoring and management of ischemic episodes.

Ambulatory electrocardiogram monitoring reveals that many patients experience frequent, often asymptomatic, transient ischemic episodes during daily activities, particularly peaking in the early hours of the day, suggesting that treatment strategies may need to be adjusted to address these occurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity of transient myocardial ischemia out of hospital in coronary artery disease and implications for management. Rocco, MB., Campbell, S., Barry, J., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of interactive patient smartphone support app on drug adherence and lifestyle changes in myocardial infarction patients: A randomized study. [2018]

2. India pubmed.ncbi.nlm.nih.gov

The effect of mobile application-based technology use on medication compliance and modification of risk factors in post PTCA cohort of patients. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Feasibility of using a mobile application for the monitoring and management of stroke-associated risk factors. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Mobile app and digital system for patients after myocardial infarction (afterAMI): study protocol for a randomized controlled trial. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Internet-based training of coronary artery patients: the Heart Cycle Trial. [2022]

6. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Evaluation of data in cardiology by new software tools. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Total ischemic burden in patients with coronary artery disease. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Visual Evidence of Ischemic Preconditioning During PCI Using 80 Lead ECG Body Surface Mapping. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Application of computerized exercise ECG digitization. Interpretation in large clinical trials. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Activity of transient myocardial ischemia out of hospital in coronary artery disease and implications for management. [2019]