HeartHome: A Nurse-Driven, Home-Based Cardiac Rehabilitation Program

Phase

N/A

Condition

Coronary Artery Disease

Chest Pain

Heart Defect

Treatment

N/A

Clinical Study ID

NCT04131816

18-2540

Ages 40-80
All Genders

Study Summary

The purpose of this implementation trial is to execute a nurse-led, home-based cardiac rehabilitation (HBCR) program, evaluate the program's impact on patient outcomes over 6 months; and compare outcomes of HeartHome (HH) participants to a group of participants in traditional cardiac rehabilitation (CR).

Eligibility Criteria

Inclusion

Individuals are eligible for the HeartHome study if they meet all the following inclusioncriteria:

Diagnosed with one of the following conditions: myocardial infarction (MI)/acutecoronary syndrome (ACS), ST-elevation myocardial infarction (STEMI), non-STEMI,percutaneous coronary intervention (PCI) or stable angina;
Decline traditional cardiac rehab or do not respond to traditional cardiac rehabenrollment methods;
Willing to have a nurse visit them in their home and receive follow-up phone calls andtext messages for a 12-week intervention period;
Understand the requirements of participation in and consent to the HeartHome program;
Live within a 75-mile radius of the study site. Individuals are not eligible for the HeartHome study if they meet any of the following

Exclusion

exclusion criteria:

Diagnosis of heart failure
Diagnosis of valvular heart disease
Presence of cardiac disease requiring surgery or other invasive procedure
Impaired mental capacity resulting in an inability to understand or follow directionsand study protocol
Impaired functional abilities that prevent them from participating in physicalactivity
Presence of any serious medical conditions that are likely to cause premature death orto impair functional capacity
No access to a telephone

Study Design

November 10, 2019

February 11, 2022

Study Description

Despite being recognized as a class 1 recommendation by the American Heart Association (AHA), traditional CR is underused: only 20% of patients who need CR are referred, and only half of those referred enroll in the program. The primary barriers to enrollment in CR include the failure of providers to refer patients; systems that lack a clear, streamlined referral process; and patients who face multiple barriers, including knowledge, transportation, cost, time, and social-family support.

The HeartHome program is adapted from MULTIFIT, an evidence-based, interdisciplinary model of care developed at Stanford University was originally designed to provide coronary risk factor modification in post-MI patients, and later modified to implement consensus guidelines for providing HBCR to individuals with CVD using nurse managed care via telephone follow-up. HeartHome will combine nurse home visits with telephone and electronic supports for participants in a HBCR program that allows them to engage in cardiac rehabilitation programs at home.

In this trial, nurses will deliver the 12-week educational program to 150 participants. Participants will then complete follow-up assessments at the end of the program (3 months post enrollment), and then at 6-months post enrollment. The data collected will be compared to a control group that contains de-identified data from 150 patients that attend the traditional cardiac rehab program.

Connect with a study center

UNC Health Care
Chapel Hill, North Carolina 27514
United States
Site Not Available

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