Life's Essential 8 for Cardiovascular Health

(VITAL Trial)

Recruiting at 1 trial location

Overseen By Madeline R Sterling, MD, MPH, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Less than 1 year experience, No smartphone, History of syncope, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the heart health of home health aides through a program called Life's Essential 8, developed by the American Heart Association. The program educates participants about healthy lifestyle choices and includes support for positive thinking. Participants will work with a peer coach—another home health aide trained for this role—over a 10-week program spread across six months. The trial seeks home health aides who have been in the job for at least a year, speak English or Spanish, and struggle with heart health issues like high blood pressure or poor diet.

As an unphased trial, this study offers a unique opportunity to enhance heart health through a supportive community and expert guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on lifestyle changes and education for heart health.

What prior data suggests that the Life's Essential 8 program is safe for home health aides?

Research shows that the Life's Essential 8 (LE8) program, developed by the American Heart Association, aims to improve heart health through lifestyle changes like eating well, exercising, and not smoking. This program supports heart health effectively.

While the study on home health aides is just beginning, earlier research on similar programs has shown good results. For instance, having a peer health coach has been linked to better blood pressure control and improved quality of life. These findings suggest that the LE8 program, when guided by peer coaches, is likely safe and easy to follow.

Overall, the program aims to make healthy habits a regular part of life, which is generally safe and beneficial for heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer Coaching Delivered Life's Essential 8 Program because it takes a fresh approach to improving cardiovascular health. Unlike standard treatments that often focus on medications or clinical interventions, this program emphasizes lifestyle changes through a structured, supportive system. Home Health Aides work closely with trained Peer Coaches to follow a comprehensive, 10-session program over six months, making it a community-based, educationally empowering method. This unique peer coaching model could lead to more sustainable lifestyle changes by fostering personal connections and accountability.

What evidence suggests that the Peer Coaching Delivered Life's Essential 8 Program is effective for cardiovascular health?

Research has shown that programs like Life's Essential 8, which emphasize heart health education and lifestyle changes, can improve heart health. In this trial, participants will receive the Peer Coaching Delivered Life's Essential 8 Program. Studies indicate that coaching can reduce hospital visits and shorten stays, suggesting better heart health. The peer coaching method used in this program has been tested in other groups, such as US veterans. While results can vary, some participants have noticed improvements in their heart health. The program aims to encourage healthy habits and positive thinking, both linked to better heart health. Overall, evidence suggests that this type of program can positively impact heart health. ^{1 2 4 6 7}

Who Is on the Research Team?

Madeline Sterling, MD, MPH, MS

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for home health aides with poor cardiovascular health. Participants should be willing to engage in a 10-week program aimed at improving heart wellness through education and lifestyle changes, guided by peer coaches who are also home health aides.

Inclusion Criteria

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)

I am currently employed as a home health aide.

I speak English or Spanish.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Life's Essential 8 program delivered by peer coaches over 10 sessions

6 months

Hybrid model with in-person and virtual sessions

Follow-up

Participants are monitored for changes in cardiovascular health and implementation outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peer Coaching Delivered Life's Essential 8 Program

Trial Overview The study tests the Life's Essential 8 (LE8) program, adapted for home health aides to improve their heart health. It involves pairing participants with trained peer coaches over six months to support healthy behaviors and positive thinking.

How Is the Trial Designed?

Group I: Peer Coaching Delivered Life's Essential 8 Program Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07067398

Improving the Heart Health of Home Health Aides ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11513497/

Coaching People with Cardiovascular Disease to Close ... Participants in The COACH Program achieved a statistically significant reduction in number of hospital episodes, length of stay in hospital, ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2805604

Effect of a Peer Health Coaching Intervention on Clinical ... In this randomized clinical trial of 264 US veterans, there was no significant improvement in SBP in participants who received the peer health coaching ...

4. ahajournals.org ahajournals.org/doi/10.1161/HCQ.0000000000000134

The Role of Primary Care in Achieving Life's Essential 8 To reduce morbidity and mortality rates of cardiovascular disease, an urgent need exists to improve cardiovascular health among US adults.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10245194/

Effect of a Peer Health Coaching Intervention on Clinical ... This randomized clinical trial assesses changes in systolic blood pressure, health-related quality of life, cardiovascular risk, and health care use

6. heart.org heart.org/en/healthy-living/healthy-lifestyle/lifes-essential-8

Life's Essential 8 Life's Essential 8 are the key measures for improving and maintaining cardiovascular health, as defined by the American Heart Association.

7. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001078

Life's Essential 8: Updating and Enhancing the ... Life's Essential 8 includes the 8 components of cardiovascular health: healthy diet, participation in physical activity, avoidance of nicotine, healthy sleep, ...