CardiovascularVITALNCT07067398
Improving the Heart Health of Home Health Aides
A study testing Peer Coaching Delivered Life's Essential 8 Program in people with Cardiovascular and Cardiovascular (CV) Risk, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular, Cardiovascular (CV) Risk, Cardiovascular Disease (CVD) Risk Factors
- What is being tested?
- Peer Coaching Delivered Life's Essential 8 Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2025to Oct 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Home Health Aide Participants
- 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)
- Peer Coach Participants
- Previously participated in and completed Peer Coach training as part of the prior LE8 study (WCM IRB #24-11028134), or are members of the Weill Cornell Medicine study team who are trained in delivering the intervention.
- Speak English or Spanish
Who cannot join
- Home Health Aide Participants
- 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
- Peer Coach Participants
- Speak a language other than English or Spanish
- Did not complete Peer Coach training as part of the prior LE8 study (WCM IRB #24-11028134), or are not members of the Weill Cornell Medicine study team who are trained in delivering the intervention.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
1199 SEIU Home Care Industry Education Fund
New York, New York, 10018
Faith Wiggins, faith.wiggins@1199funds.org
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Madeline R Sterling, MD, MPH, MS, 646-962-5029, mrs9012@med.cornell.edu
About this study
Official title: Improving the Cardiovascular Health of Home Health Aides
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:
Read more
- 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.
Read the detailed description
The goal of the proposed project is to improve the cardiovascular (CV) health of home health aides and attendants (HHAs), one of the fastest growing sectors of the healthcare industry, comprised predominantly of middle-aged women of color with a high burden of CV disease risk factors, including obesity, hypertension, hyperlipidemia, physical inactivity, and smoking. Improving HHAs' cardiovascular health and well-being is not only critical to their own longevity as a workforce, but it has the potential to improve the health of the patients for whom they care. The overall goal of the study is to test the preliminary effectiveness of the peer-coach (PC) delivered Life's Essential 8 (LE8) intervention program among 40 HHAs with poor CV health, while gathering data on its implementation.
The investigators have 3 main hypotheses. Under Aim 1, the investigators hypothesize that HHAs who receive the intervention will have higher CV health at follow-up compared to baseline. Under Aim 2, the investigators hypothesize that drivers of implementation will include: intervention adaptability, local conditions, work infrastructure, recipient centeredness, and motivation. Also under Aim 2, the investigators hypothesize the intervention will be feasible (>80% HHAs complete the study) and acceptable (>90% HHAs high levels of satisfaction).
All aspects of the study, including the intervention itself, will be conducted using a hybrid (in-person and virtual) model, with some sessions being completed online and others in person.
- Conditions
- Cardiovascular, Cardiovascular (CV) Risk, Cardiovascular Disease (CVD) Risk Factors, Cardiovascular Health
- Being tested
- Peer Coaching Delivered Life's Essential 8 Program
- Keywords
- cardiovascular health intervention, home health aide, peer coaching
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Coaching Delivered Life's Essential 8 ProgramBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Peer Coaching Delivered Life's Essential 8 Program | Experimental | Home Health Aides (HHAs) will receive educational content via paper-based booklets. HHAs will receive the 10-session adapted Life's Essential 8 program over 6 months. Each HHA will be paired with a trained Peer Coach participant who will work through the structured program with the HHA. Receives: Behavioral: Peer Coaching Delivered Life's Essential 8 Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness, which will be assessed by a change from baseline in overall cardiovascular health score as measured by LE8.
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.
Measured: From baseline to end of the intervention at 6 months
Secondary outcomes (14)
Implementation, which will be assessed by acceptability through a qualitative interview
Acceptability defined as participant satisfaction of the study will be assessed through a qualitative interview
Measured: One 30-90 minute session following the end of the intervention at 6 months
Implementation, which will be assessed by acceptability through a survey
Acceptability will be assessed through the 4-item, validated, Acceptability of Intervention Measure. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived acceptability of the intervention.
Measured: Following the end of the intervention at 6 months
Implementation, which will be assessed by feasibility through a qualitative interview
We will ask peer coaches about the intervention's feasibility, or how viable it was considering their experience, through qualitative interviews.
Measured: One 30-90 minute session following the end of the intervention at 6 months
Implementation assessed by feasibility through HHA eligibility
Feasibility will be assessed with the number of HHAs eligible to receive the intervention.
Measured: Following the end of the intervention at 6 months
Implementation assessed by feasibility through intervention receipt
Feasibility will be assessed with the number of HHAs who receive the intervention.
Measured: Following the end of the intervention at 6 months
Implementation assessed by feasibility through intervention completion
Feasibility will be assessed with the number of HHAs who completed the intervention.
Measured: Following the end of the intervention at 6 months
Implementation assessed by feasibility through staffing requirements
Feasibility will be assessed with the number of additional staff needed for implementation determined as the study progresses.
Measured: Following the end of the intervention at 6 months
Implementation, which will be assessed by feasibility through a survey
Feasibility will be assessed with a validated, 4-item, Feasibility of Intervention Measure. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived feasibility of the intervention.
Measured: Following the end of the intervention at 6 months
Implementation, which will be assessed by fidelity through a process measure
Fidelity defined as number of subjects who adhered to the intervention as assessed with checklists tracking participants' completion of scheduled educational lessons.
Measured: From baseline to end of the intervention at 6 months
Implementation, which will in part be assessed by adaptation through a process measure
Adaptation defined as number of changes made to the intervention during the study will be assessed by documenting how the intervention was modified and refined.
Measured: From baseline to end of the intervention at 6 months
Effectiveness assessed by change in perceived social support measured by the Social Support Scale.
Social support will be assessed with a validated 4-items measure of perceived adequacy of social support from people in one's life and on the job. Items are measured on a 5-point Likert scale (Not at all-Very much). The score is calculated as the mean across items reported per day. Higher scores indicate greater perceived social support from colleagues and supervisors in response to daily work stressors.
Measured: From baseline to end of the intervention at 6 months
Effectiveness assessed by change in self-efficacy measured by the General Self-Efficacy Scale.
Self-efficacy will be assessed with a validated, 10-item measure of one's confidence in handling situations related to health, job, personal life. Items are measured on a 4-point Likert scale (Not at all true-Exactly true). The score is calculated as the sum or mean of all items. The scale ranges from 10-40 (sum) or 1-4 (mean), with higher scores indicating greater perceived general self-efficacy.
Measured: From baseline to end of the intervention at 6 months
Effectiveness assessed by change in job satisfaction measured by the Job Satisfaction Scale.
Job satisfaction will be assessed with a validated, 5-item measure that assesses satisfaction with current job. Items are measured on a 7-point Likert scale (Strongly Disagree-Strongly Agree). The score is calculated as the mean of all items. The scale ranges from 1-7, with higher scores indicating greater satisfaction with one's work.
Measured: From baseline to end of the intervention at 6 months
Effectiveness assessed by change in turnover intention measured by the Turnover Intention Scale.
Turnover intention as an employment-related outcome will be assessed with a validated, 2-item measure that assesses likelihood to leave job. Items are measured on a 5-point Likert scale (Strongly Disagree-Strongly Agree). The score is calculated as the mean of all items. The scale ranges from 1-5, with higher scores indicating a stronger intention to leave one's job or the workforce.
Measured: From baseline to end of the intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start9 Sep 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Madeline Sterling, MD, MPH, MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067398
- Sponsor's protocol ID
- 25-01028456
- Other IDs
- 23SCISA1142170
- Acronym
- VITAL
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Cardiovascular Health of Home Health Aides
- ClinicalTrials.gov ID
- NCT07067398
- Acronym / sponsor ID
- VITAL / 25-01028456
- Conditions
- Cardiovascular, Cardiovascular (CV) Risk, Cardiovascular Disease (CVD) Risk Factors, Cardiovascular Health
- Keywords
- cardiovascular health intervention, home health aide, peer coaching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Jul 2025 (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.
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.
Detailed description
The goal of the proposed project is to improve the cardiovascular (CV) health of home health aides and attendants (HHAs), one of the fastest growing sectors of the healthcare industry, comprised predominantly of middle-aged women of color with a high burden of CV disease risk factors, including obesity, hypertension, hyperlipidemia, physical inactivity, and smoking. Improving HHAs' cardiovascular health and well-being is not only critical to their own longevity as a workforce, but it has the potential to improve the health of the patients for whom they care. The overall goal of the study is to test the preliminary effectiveness of the peer-coach (PC) delivered Life's Essential 8 (LE8) intervention program among 40 HHAs with poor CV health, while gathering data on its implementation.
The investigators have 3 main hypotheses. Under Aim 1, the investigators hypothesize that HHAs who receive the intervention will have higher CV health at follow-up compared to baseline. Under Aim 2, the investigators hypothesize that drivers of implementation will include: intervention adaptability, local conditions, work infrastructure, recipient centeredness, and motivation. Also under Aim 2, the investigators hypothesize the intervention will be feasible (>80% HHAs complete the study) and acceptable (>90% HHAs high levels of satisfaction).
All aspects of the study, including the intervention itself, will be conducted using a hybrid (in-person and virtual) model, with some sessions being completed online and others in person.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer Coaching Delivered Life's Essential 8 Program | Experimental | Behavioral: Peer Coaching Delivered Life's Essential 8 ProgramHome Health Aides (HHAs) will receive educational content via paper-based booklets. HHAs will receive the 10-session adapted Life's Essential 8 program over 6 months. Each HHA will be paired with a trained Peer Coach participant who will work through the structured program with the HHA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Home Health Aide Participants
- 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)
Key exclusion criteria (8 listed)
- Home Health Aide Participants
- 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
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 |
|---|---|---|
| Peer Coaching Delivered Life's Essential 8 ProgramThis 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). | Behavioural | Peer Coaching Delivered Life's Essential 8 Program |
Primary outcome
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.
14 secondary outcomes
Implementation, which will be assessed by acceptability through a qualitative interview
Time frame: One 30-90 minute session following the end of the intervention at 6 months
Implementation, which will be assessed by acceptability through a survey
Time frame: Following the end of the intervention at 6 months
Implementation, which will be assessed by feasibility through a qualitative interview
Time frame: One 30-90 minute session following the end of the intervention at 6 months
Implementation assessed by feasibility through HHA eligibility
Time frame: Following the end of the intervention at 6 months
Implementation assessed by feasibility through intervention receipt
Time frame: Following the end of the intervention at 6 months
Implementation assessed by feasibility through intervention completion
Time frame: Following the end of the intervention at 6 months
Implementation assessed by feasibility through staffing requirements
Time frame: Following the end of the intervention at 6 months
Implementation, which will be assessed by feasibility through a survey
Time frame: Following the end of the intervention at 6 months
Implementation, which will be assessed by fidelity through a process measure
Time frame: From baseline to end of the intervention at 6 months
Implementation, which will in part be assessed by adaptation through a process measure
Time frame: From baseline to end of the intervention at 6 months
Effectiveness assessed by change in perceived social support measured by the Social Support Scale.
Time frame: From baseline to end of the intervention at 6 months
Effectiveness assessed by change in self-efficacy measured by the General Self-Efficacy Scale.
Time frame: From baseline to end of the intervention at 6 months
Effectiveness assessed by change in job satisfaction measured by the Job Satisfaction Scale.
Time frame: From baseline to end of the intervention at 6 months
Effectiveness assessed by change in turnover intention measured by the Turnover Intention Scale.
Time frame: From baseline to end of the intervention at 6 months
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Madeline Sterling, MD, MPH, MS principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Coaching Delivered Life's Essential 8 Program in people with Cardiovascular and Cardiovascular (CV) Risk, run by Weill Medical College of Cornell University at 2 sites 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 8 inclusion and 8 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Madeline R Sterling, MD, MPH, MS (6469625029, mrs9012@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 20 Aug 2026.