Clinical trial NCT04131816: HeartHome: A Nurse-Driven, Home-Based Cardiac Rehabilitation Program
Official title: HeartHome: A Nurse-Driven, Home-Based Cardiac Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Acute Coronary Syndrome
ST-segment Elevation Myocardial Infarction (STEMI)
Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
Angina, Stable
Keywords: Cardiac Rehabilitation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Individuals are eligible for the HeartHome study if they meet all the following 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.

Individuals are not eligible for the HeartHome study if they meet any of the following 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

Primary outcomes:
measure: Number of HeartHome patient referrals into the HeartHome program
timeFrame: 10 months after beginning of study
measure: Proportion of HeartHome patient referral into the HeartHome program
timeFrame: 10 months after beginning of study
measure: Proportion of HeartHome patient enrollments in the HeartHome program
timeFrame: 10 months after beginning of study
measure: Participation in HeartHome's participants in-person visits
timeFrame: 12 weeks post HeartHome intervention start
measure: Participation in HeartHome's participants interactive online classes
timeFrame: 12 weeks post HeartHome intervention start
measure: Participation in HeartHome intervention calls
timeFrame: 12 weeks post HeartHome intervention start
measure: HeartHome intervention weekly goal adherence score
timeFrame: 12 weeks post HeartHome intervention start
measure: Number of sessions completed.
timeFrame: 13-weeks post start of HeartHome and control intervention
Secondary outcomes:
measure: HeartHome participants' physical function at baseline and at week 12
timeFrame: 12 weeks post start of HeartHome intervention
measure: Change in HeartHome participant's physical functioning, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.
timeFrame: 12- and 24-weeks post start of intervention
measure: Change in HeartHome participant's role limitations due to physical health, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.
timeFrame: 12- and 24- weeks post start of intervention
measure: Change in HeartHome participant's role limitations due to emotional problems, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.
timeFrame: 12- and 24- weeks post start of intervention
measure: Change in HeartHome participant's energy/fatigue, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.
timeFrame: 12- and 24- weeks post start of intervention
measure: HeartHome participant's emotional well-being, sub score of RAND SF-36, assessed at baseline, week 12, and week 24.
timeFrame: 12- and 24-weeks post start of intervention
measure: HeartHome participant's social functioning, sub score of RAND SF-36, evaluated at baseline, week 12, and week 24.
timeFrame: 12- and 24-weeks post start of intervention
measure: HeartHome participant's bodily pain, a sub score of RAND SF-36, will be evaluated at baseline, week 12 and week 24.
timeFrame: 12- and 24- weeks post start of intervention
measure: HeartHome participant's general health, sub score of RAND SF-36 at baseline, week 12, and week 24.
timeFrame: 12- and 24-weeks post start of intervention
measure: HeartHome participant's change of participant and control physical functioning, sub score of RAND SF-36, from baseline to week 12 to end of program
timeFrame: 13-weeks post start of HeartHome and control intervention
measure: HeartHome participant's blood pressure at baseline and weeks 3, 5, 7 and 12.
timeFrame: Baseline, weeks 3, 5, 7, and 12 of intervention
measure: Participants' and control's blood pressure at baseline and 12 weeks
timeFrame: Baseline and 13-weeks post start of HeartHome and control intervention
measure: Change in HeartHome participant's reported nicotine use from baseline to week 12 and baseline to week 24.
timeFrame: 12- and 24-weeks post start of intervention
measure: HeartHome participant's waist circumference from baseline to week 12.
timeFrame: 12 weeks post start of intervention
measure: HeartHome participant's Body Mass Index at baseline and week 12.
timeFrame: Baseline and 12 weeks post start of intervention
measure: Change of HeartHome participants' and control Body Mass Index from baseline to week 12
timeFrame: Baseline and 13-weeks post start of HeartHome and control intervention
measure: HeartHome participant's average weekly steps walked from baseline to week 12.
timeFrame: 12 weeks post start of intervention
measure: HeartHome participant's self-Reported and medical record reviewed number of hospital admissions 12 and 24 weeks after beginning of heart home program.
timeFrame: 12- and 24- weeks post start of intervention
measure: HeartHome participant's self-Reported and medical record reviewed number of days hospitalized 12 and 24 weeks after beginning of heart home program.
timeFrame: 12- and 24- weeks post start of intervention
measure: HeartHome participant and control number of hospital readmissions at 12 weeks
timeFrame: 13-weeks post start of HeartHome and control intervention
measure: HeartHome participant's self-reported and medical record reviewed number of ED visits without hospital admissions 12 and 24 weeks after beginning of HeartHome program
timeFrame: 12- and 24- weeks post start of intervention
measure: HeartHome participant's self-reported and medical record reviewed number of specialist visits 12 and 24 weeks after beginning of the HeartHome program
timeFrame: 12- and 24- weeks post start of intervention
measure: HeartHome participant's self-reported and medical record reviewed number of primary care visits 12 and 24 weeks after beginning of the HeartHome program
timeFrame: 12- and 24- weeks post start of intervention
measure: HeartHome participant's self-reported and medical record reviewed number of urgent care visits 12 and 24 weeks after beginning of the HeartHome program
timeFrame: 12- and 24- weeks post start of intervention
measure: HeartHome participant's Morisky 4-Item Scale scores at baseline, week 12, and week 24.
timeFrame: 12- and 24-weeks post start of intervention
measure: HeartHome participant's change in perceived stress scale from baseline to week 12 and baseline to week 24.
timeFrame: 12 and 24 weeks post start of intervention
measure: HeartHome participant's change in dietary risk assessment from baseline to week 12 and baseline to week 24.
timeFrame: 12- and 24- weeks post start of intervention
measure: Participants' and control's dietary risk assessment scores from baseline to week 12 to dietary risk assessment scores of control group.
timeFrame: 13-weeks post start of HeartHome and control intervention
measure: HeartHome participant's change in PHQ-9 from baseline to week 12.
timeFrame: 12 weeks post start of intervention
measure: Change in participants' and control's PHQ-9 from baseline to week 12.
timeFrame: 13-weeks post start of HeartHome and control intervention
measure: HeartHome participant's change in New General Self-Efficacy score from baseline to week 12 and baseline to week 24.
timeFrame: 12- and 24-weeks post start of intervention
measure: HeartHome participant's change in knowledge of cardiac rehabilitation from baseline to 12 weeks and baseline to 24 weeks.
timeFrame: 12- and 24-weeks post start of intervention
measure: Participants' and control's change in knowledge of cardiac rehabilitation from baseline to 12 weeks.
timeFrame: 13-weeks post start of HeartHome and control intervention
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Health Care
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Cheryl Jones, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: