Improving the Heart Health of Home Health Aides

NCT ID: NCT07067398

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-09

Study Completion Date

2026-09-30

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Peer Coaching Delivered Life's Essential 8 Program

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.

Group Type EXPERIMENTAL

Peer Coaching Delivered Life's Essential 8 Program

Intervention Type 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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madeline Sterling, MD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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1199 SEIU Home Care Industry Education Fund

New York, New York, United States

Site Status NOT_YET_RECRUITING

Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Madeline R Sterling, MD, MPH, MS

Role: CONTACT

6469625029

Facility Contacts

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Faith Wiggins

Role: primary

Madeline R Sterling, MD, MPH, MS

Role: primary

646-962-5029

Other Identifiers

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23SCISA1142170

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

25-01028456

Identifier Type: -

Identifier Source: org_study_id

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