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Recruiting NCT07067398

Improving the Heart Health of Home Health Aides

No phase Interventional Cardiovascular Cardiovascular (CV) Risk Cardiovascular Disease (CVD) Risk Factors Cardiovascular Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peer Coaching Delivered Life's Essential 8 Program.
Who it may be relevant to
Registry conditions: Cardiovascular, Cardiovascular (CV) Risk, Cardiovascular Disease (CVD) Risk Factors, Cardiovascular Health. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Improving the Cardiovascular Health of Home Health Aides

Overview

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

  • Behavioral 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 w

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]
  • Implementation, which will be assessed by acceptability through a survey [Time frame: Following the end of the intervention at 6 months]
  • 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]
  • Implementation assessed by feasibility through HHA eligibility [Time frame: Following the end of the intervention at 6 months]
  • Implementation assessed by feasibility through intervention receipt [Time frame: Following the end of the intervention at 6 months]
  • Implementation assessed by feasibility through intervention completion [Time frame: Following the end of the intervention at 6 months]
  • Implementation assessed by feasibility through staffing requirements [Time frame: Following the end of the intervention at 6 months]
  • Implementation, which will be assessed by feasibility through a survey [Time frame: Following the end of the intervention at 6 months]
  • Implementation, which will be assessed by fidelity through a process measure [Time frame: From baseline to end of the intervention at 6 months]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 2 centers
  • 1199 SEIU Home Care Industry Education Fund — New York
  • Weill Cornell Medicine — New York

Identifiers

NCT: NCT07067398 · 25-01028456 · 23SCISA1142170

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗