NCT07067398 · Weill Medical College of Cornell University
Improving the Heart Health of Home Health Aides
(VITAL)
What this study is about
The goal of this early-stage study is to support the heart health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. To do this, the study will use Life's Essential 8 (LE8), a program developed by the American Heart Association (AHA) that promotes cardiovascular wellness through education and lifestyle changes.
View original scientific description
The goal of this early-stage study is to support the heart health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. To do this, the study will use Life's Essential 8 (LE8), a program developed by the American Heart Association (AHA) that promotes cardiovascular wellness through education and lifestyle changes. The program has been adapted specifically for home health aides and will be delivered by trained "peer coaches," who are fellow home health aides who will help guide participants through the program. The main questions the study aims to answer are: * Will the LE8 intervention, which provides cardiovascular health education and support with positive thinking, be used by home health aides and do they like it? * Does the LE8 intervention actually improve home health aides' cardiovascular health after the intervention's conclusion compared to baseline? Participants will be paired with a trained peer coach and take part in the 10-week program over the course of 6 months. The program includes support for healthy behaviors and positive thinking, with the goal of making lasting improvements in cardiovascular health.
Interventions
BEHAVIORAL
Peer Coaching Delivered Life's Essential 8 Program
This intervention includes structured bi-weekly peer coach (PC) Zoom or telephone sessions and a cardiovascular health curriculum including links to AHA resources. During the 1:1 session, PCs will elicit participants' challenges and successes from the previous week, track progress, and set goals (behavioral targets). PCs will use cognitive training techniques to teach participants how to manage negative thinking and replace it with positive thinking and goal setting. They will be encouraged to work towards these goals and monitor their progress (i.e. getting more physical activity on the job).
Primary outcome measures
Effectiveness, which will be assessed by a change from baseline in overall cardiovascular health score as measured by LE8.
Time frame: From baseline to end of the intervention at 6 months
Each individual Life's Essential 8 (LE8) domain (physical activity level, diet, smoking, sleep, and physiologic health (systolic and diastolic blood pressure), BMI, hemoglobin A1C, and non-HDL cholesterol) has a score of 0 to 100, with higher values indicating better cardiovascular health in each domain. The LE8 overall score is created by averaging individual scores across 8 domains. The overall score ranges from 0 to 100 with higher numerical values corresponding to better cardiovascular health.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Currently working as a home health aide
- Speak English or Spanish
- ≥ 18 years of age
- Have low CV Health as assessed by LE8 components made up by physical health measurements (blood pressure, BMI) and general self-reported health (physical activity, diet, smoking, sleep); calculated to be a score of 0-50 (the total score ranges from 0-100)
Exclusion criteria
- Less than 1 year of job experience as a home health aide
- Does not possess a smartphone
- Gotten dizzy before with a finger stick blood sugar/cholesterol test
- Have a history of syncope with a finger stick blood sugar/cholesterol test
Where
- New York, New York
Collaborators
American Heart Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations