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

NCT ID: NCT04131816

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-10
• Study Completion Date: 2022-02-11

Brief 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).

Detailed 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.

Conditions

Myocardial Infarction; Acute Coronary Syndrome; ST-segment Elevation Myocardial Infarction (STEMI); Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); Angina, Stable

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HeartHome Intervention

Participants will be in the HeartHome program for a total of 12 weeks.

Group Type: EXPERIMENTAL

HeartHome

Intervention Type: BEHAVIORAL

The HeartHome program is an expanded home-based cardiac rehabilitation program that combines nurse home visits with telephone and electronic supports for participants that allows them to engage in cardiac rehabilitation activities at home.

Control

De-identified data from 150 patients who attend a traditional cardiac rehabilitation program during the same general time of the HeartHome implementation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HeartHome

The HeartHome program is an expanded home-based cardiac rehabilitation program that combines nurse home visits with telephone and electronic supports for participants that allows them to engage in cardiac rehabilitation activities at home.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed with one of the following conditions: myocardial infarction (MI)/acute coronary 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 rehab enrollment methods;
• Willing to have a nurse visit them in their home and receive follow-up phone calls and text 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.

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 directions and study protocol
• Impaired functional abilities that prevent them from participating in physical activity
• Presence of any serious medical conditions that are likely to cause premature death or to impair functional capacity
• No access to a telephone

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl Jones, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Health Care

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

18-2540

Identifier Type: -

Identifier Source: org_study_id