Clinical Trials Directory

Trials / Completed

CompletedNCT04131816

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
14 (actual)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
All
Age
40 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALHeartHomeThe 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.

Timeline

Start date
2019-11-10
Primary completion
2022-02-11
Completion
2022-02-11
First posted
2019-10-18
Last updated
2022-04-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04131816. Inclusion in this directory is not an endorsement.