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

Primary Purpose

Ischemic Heart Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GeriKit Mobile Application
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Ischemic Heart Disease focused on measuring GeriKit, Comprehensive Geriatric Assessment (CGA)

Eligibility Criteria

75 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 75 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 Capable of self-consent Understand and are able to perform study procedures in English Exclusion Criteria: Non-ambulatory Moderate or severe cognitive impairment (operationalized as known diagnosis of dementia) Unable or unwilling to consent Incarcerated Unable to use complete assessments in English Unable to complete geriatric assessment for other reasons

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Geriatric Assessments using GeriKit App

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 15, 2023
Last Updated
June 1, 2023
Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05788666
Brief Title
Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease
Official Title
Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
GeriKit, Comprehensive Geriatric Assessment (CGA)

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Geriatric Assessments using GeriKit App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
GeriKit Mobile Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Mortality or Hospital Readmission
Description
Binary outcome; determined by review of patient electronic health record (EHR) data at Month 6.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
12-Item Short Form Survey (SF-12) Score
Description
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.
Time Frame
Baseline
Title
12-Item Short Form Survey (SF-12) Score
Description
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.
Time Frame
Month 6
Title
Seattle Angina Questionnaire Short-Form (SAQ-7)
Description
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.
Time Frame
Baseline
Title
Seattle Angina Questionnaire Short-Form (SAQ-7)
Description
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.
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 75 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 Capable of self-consent Understand and are able to perform study procedures in English Exclusion Criteria: Non-ambulatory Moderate or severe cognitive impairment (operationalized as known diagnosis of dementia) Unable or unwilling to consent Incarcerated Unable to use complete assessments in English Unable to complete geriatric assessment for other reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John A. Dodson, MD, MPH, FACC
Phone
(646) 501-2714
Email
Cdhlab@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Pena
Phone
(646) 618-2841
Email
Cdhlab@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Dodson, MD, MPH, FACC
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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