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

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788666
• Other study ID #: 22-00841
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: John A. Dodson, MD, MPH, FACC
• Phone: (646) 501-2714
• Email: Cdhlab[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Mortality or Hospital Readmission	Binary outcome; determined by review of patient electronic health record (EHR) data at Month 6.	Month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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