Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Procedure: GeriKit Mobile Application

Detailed Description

This is a single-center proof of concept study of geriatric impairments and feasibility metrics through the use of the GeriKit software application in older adults with ischemic heart disease at the NYU Langone Medical Center. The GeriKit mobile application was developed to make geriatric assessment instruments easily accessible to clinicians who do not have subspecialty training in geriatrics. The GeriKit app has been used clinically but is untested in research settings.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John A. Dodson, MD, MPH, FACC; Phone Number: (646) 501-2714; Email: Cdhlab@nyulangone.org
• Study Contact Backup: Name: Victoria Rosado Santiago; Phone Number: 9(917) 838-1699; Email: victoria.rosadosantiago@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Principal Investigator: John Dodson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 75
2. Currently hospitalized for acute mycardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG); or hospitalized for AMI, PCI, or CABG within the prior 4 weeks
3. Capable of self-consent
4. Understand and are able to perform study procedures in English

Exclusion Criteria:

1. Non-ambulatory
2. Moderate or severe cognitive impairment (operationalized as known diagnosis of dementia)
3. Unable or unwilling to consent
4. Incarcerated
5. Unable to use complete assessments in English
6. Unable to complete geriatric assessment for other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Geriatric Assessments using GeriKit App; 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.	Procedure: GeriKit Mobile Application; Digital health app used for comprehensive geriatric assessment (CGA). The app includes a series of brief, well-validated instruments: the MiniCog, 30-Second Chair Stand, Activities of Daily Living, Instrumental Activities of Daily Living, Patient Health Questionnaire (PHQ-9), Mini Nutrition Assessment, 2-Item Fall Screen, and Polypharmacy screen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Mortality or Hospital Readmission	Binary outcome; determined by review of patient electronic health record (EHR) data at Month 6.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-Item Short Form Survey (SF-12) Score	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the higher the score, the better the physical and mental health functioning.	Baseline
12-Item Short Form Survey (SF-12) Score	The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the higher the score, the better the physical and mental health functioning.	Month 6
Seattle Angina Questionnaire Short-Form (SAQ-7)	7-item questionnaire assessing functional status, angina and disease-specific health-related quality of life (HRQoL) over a four-week recall period. Responses generate a summary score ranging from 0-100, where 100 = full health, and 0 = worst health.	Baseline
Seattle Angina Questionnaire Short-Form (SAQ-7)	7-item questionnaire assessing functional status, angina and disease-specific health-related quality of life (HRQoL) over a four-week recall period. Responses generate a summary score ranging from 0-100, where 100 = full health, and 0 = worst health.	Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: John A. Dodson, MD, MPH, FACC, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Comprehensive Geriatric Assessment (CGA); GeriKit
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia
• Other Study ID Numbers: 22-00841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: cdhlab@nyumc.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to cdhlab@nyumc.org. To gain access, data requestors will need to sign a data access agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No