Improving the Heart Health of Home Health Aides

NCT07067398 | Recruiting DMC

• 2 other identifiers: 25-0102845623SCISA1142170
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

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

Keywords

cardiovascular health intervention; home health aide; peer coaching

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to end of the intervention at 6 months

Secondary Outcomes (14)

• Implementation, which will be assessed by acceptability through a qualitative interview

  One 30-90 minute session following the end of the intervention at 6 months

• Implementation, which will be assessed by acceptability through a survey

  Following the end of the intervention at 6 months

• Implementation, which will be assessed by feasibility through a qualitative interview

  One 30-90 minute session following the end of the intervention at 6 months

• Implementation, which will be assessed by feasibility through a process measure

  Following the end of the intervention at 6 months

• Implementation, which will be assessed by feasibility through a process measure

  Following the end of the intervention at 6 months

Study Arms (1)

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.

Behavioral: Peer Coaching Delivered Life's Essential 8 Program

Interventions

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).

Peer Coaching Delivered Life's Essential 8 Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• American Heart Association: collaborator

Study Sites (2)

1199 SEIU Home Care Industry Education Fund

New York, New York, 10018, United States

NOT YET RECRUITING

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Madeline Sterling, MD, MPH, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline R Sterling, MD, MPH, MS

CONTACT

6469625029; mrs9012@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 16, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)