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Improving the Heart Health of Home Health Aides

Improving the Cardiovascular Health of Home Health Aides

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07067398
Acronym
VITAL
Enrollment
40
Registered
2025-07-16
Start date
2025-09-09
Completion date
2026-10-01
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cardiovascular health intervention, home health aide, peer coaching

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.

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.

Interventions

BEHAVIORALPeer 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).

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER
American Heart Association
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness, which will be assessed by a change from baseline in overall cardiovascular health score as measured by LE8.From baseline to end of the intervention at 6 monthsEach 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

MeasureTime frameDescription
Implementation, which will be assessed by acceptability through a qualitative interviewOne 30-90 minute session following the end of the intervention at 6 monthsAcceptability defined as participant satisfaction of the study will be assessed through a qualitative interview
Implementation, which will be assessed by acceptability through a surveyFollowing the end of the intervention at 6 monthsAcceptability 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.
Implementation, which will be assessed by feasibility through a qualitative interviewOne 30-90 minute session following the end of the intervention at 6 monthsWe will ask peer coaches about the intervention's feasibility, or how viable it was considering their experience, through qualitative interviews.
Implementation assessed by feasibility through HHA eligibilityFollowing the end of the intervention at 6 monthsFeasibility will be assessed with the number of HHAs eligible to receive the intervention.
Implementation assessed by feasibility through intervention receiptFollowing the end of the intervention at 6 monthsFeasibility will be assessed with the number of HHAs who receive the intervention.
Implementation assessed by feasibility through intervention completionFollowing the end of the intervention at 6 monthsFeasibility will be assessed with the number of HHAs who completed the intervention.
Implementation assessed by feasibility through staffing requirementsFollowing the end of the intervention at 6 monthsFeasibility will be assessed with the number of additional staff needed for implementation determined as the study progresses.
Implementation, which will be assessed by feasibility through a surveyFollowing the end of the intervention at 6 monthsFeasibility 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.
Implementation, which will be assessed by fidelity through a process measureFrom baseline to end of the intervention at 6 monthsFidelity defined as number of subjects who adhered to the intervention as assessed with checklists tracking participants' completion of scheduled educational lessons.
Implementation, which will in part be assessed by adaptation through a process measureFrom baseline to end of the intervention at 6 monthsAdaptation defined as number of changes made to the intervention during the study will be assessed by documenting how the intervention was modified and refined.
Effectiveness assessed by change in perceived social support measured by the Social Support Scale.From baseline to end of the intervention at 6 monthsSocial 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.
Effectiveness assessed by change in self-efficacy measured by the General Self-Efficacy Scale.From baseline to end of the intervention at 6 monthsSelf-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.
Effectiveness assessed by change in job satisfaction measured by the Job Satisfaction Scale.From baseline to end of the intervention at 6 monthsJob 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.
Effectiveness assessed by change in turnover intention measured by the Turnover Intention Scale.From baseline to end of the intervention at 6 monthsTurnover 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.

Countries

United States

Contacts

CONTACTMadeline R Sterling, MD, MPH, MS
mrs9012@med.cornell.edu6469625029
PRINCIPAL_INVESTIGATORMadeline Sterling, MD, MPH, MS

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026