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NCT Number: NCT07067398

Improving the Heart 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:

* 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.

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Key information

Conditions

Cardiovascular Cardiovascular (CV) Risk Cardiovascular Disease (CVD) Risk Factors Cardiovascular Diseases Cardiovascular Health

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

1199 SEIU Home Care Industry Education Fund, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer Coaching Delivered Life's Essential 8 Program

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

    Acceptability defined as participant satisfaction of the study will be assessed through a qualitative interview

  2. Implementation, which will be assessed by acceptability through a survey

    Time frame: Following the end of the intervention at 6 months

    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.

  3. 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

    We will ask peer coaches about the intervention's feasibility, or how viable it was considering their experience, through qualitative interviews.

  4. Implementation assessed by feasibility through HHA eligibility

    Time frame: Following the end of the intervention at 6 months

    Feasibility will be assessed with the number of HHAs eligible to receive the intervention.

  5. Implementation assessed by feasibility through intervention receipt

    Time frame: Following the end of the intervention at 6 months

    Feasibility will be assessed with the number of HHAs who receive the intervention.

  6. Implementation assessed by feasibility through intervention completion

    Time frame: Following the end of the intervention at 6 months

    Feasibility will be assessed with the number of HHAs who completed the intervention.

  7. Implementation assessed by feasibility through staffing requirements

    Time frame: Following the end of the intervention at 6 months

    Feasibility will be assessed with the number of additional staff needed for implementation determined as the study progresses.

  8. Implementation, which will be assessed by feasibility through a survey

    Time frame: Following the end of the intervention at 6 months

    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.

  9. Implementation, which will be assessed by fidelity through a process measure

    Time frame: From baseline to end of the intervention at 6 months

    Fidelity defined as number of subjects who adhered to the intervention as assessed with checklists tracking participants' completion of scheduled educational lessons.

  10. 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

    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.

  11. 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

    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.

  12. 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

    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.

  13. 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

    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.

  14. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Madeline R Sterling, MD, MPH, MS

CONTACT

[email protected]

6469625029

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Improving the Cardiovascular Health of Home Health Aides

Acronym: VITAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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