Ischemic Heart DiseaseNCT05788666
Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease
A study testing GeriKit Mobile Application in people with Ischemic Heart Disease, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 75 to 100 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- GeriKit Mobile Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
John Dodson, MD
About this study
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- GeriKit Mobile Application
- Keywords
- GeriKit, Comprehensive Geriatric Assessment (CGA)
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeriKit Mobile ApplicationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Assessments using GeriKit App | Experimental | 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. Receives: Procedure: GeriKit Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Mortality or Hospital Readmission
Binary outcome; determined by review of patient electronic health record (EHR) data at Month 6.
Measured: Month 6
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start18 Jan 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- John A. Dodson, MD, MPH, FACC, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788666
- Sponsor's protocol ID
- 22-00841
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT05788666
- Acronym / sponsor ID
- 22-00841
- Conditions
- Ischemic Heart Disease
- Keywords
- GeriKit, Comprehensive Geriatric Assessment (CGA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Assessments using GeriKit App | Experimental | Procedure: GeriKit Mobile ApplicationParticipants 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 may qualify
- Ages
- 75 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GeriKit Mobile ApplicationDigital 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. | Procedure or surgery | Geriatric Assessments using GeriKit App |
Primary outcome
Incidence of Mortality or Hospital Readmission
Time frame: Month 6
Binary outcome; determined by review of patient electronic health record (EHR) data at Month 6.
4 secondary outcomes
12-Item Short Form Survey (SF-12) Score
Time frame: Baseline
12-Item Short Form Survey (SF-12) Score
Time frame: Month 6
Seattle Angina Questionnaire Short-Form (SAQ-7)
Time frame: Baseline
Seattle Angina Questionnaire Short-Form (SAQ-7)
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John A. Dodson, MD, MPH, FACC principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GeriKit Mobile Application in people with Ischemic Heart Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John A. Dodson, MD, MPH, FACC ((646) 501-2714, Cdhlab@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Mortality or Hospital Readmission (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.