HeartHome: A Nurse-Driven, Home-Based Cardiac Rehabilitation Program
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Number of HeartHome patient referrals into the HeartHome program
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of HeartHome patient referrals into the HeartHome program
Time Frame: 10 months after beginning of study
Number of patient referrals into the HeartHome program will be measured by the total number of participants eligible to enroll in traditional cardiac rehab that were referred to the HeartHome program.
Proportion of HeartHome patient referral into the HeartHome program
Time Frame: 10 months after beginning of study
Proportion of patient referrals into the HeartHome program will be measured by the number of patients referred to the HeartHome program relative to the number of patients referred to traditional cardiac rehab.
Proportion of HeartHome patient enrollments in the HeartHome program
Time Frame: 10 months after beginning of study
Proportion of patient enrollments in the HeartHome program will be measured by the number of patients who enroll in the HeartHome program relative to the number of eligible patients referred to the HeartHome program. Enrollment is defined by signing the study consent form.
Participation in HeartHome's participants in-person visits
Time Frame: 12 weeks post HeartHome intervention start
Participation in HeartHome's in-person visits will be measured by the number of in-person visits that each participant attends relative to the total number of in-person visits. The total number of visits possible per person is 5, with higher numbers associated with better participation.
Participation in HeartHome's participants interactive online classes
Time Frame: 12 weeks post HeartHome intervention start
Participation in HeartHome's online classes will be measured by the number of online classes that each participant attends relative to the total number of interactive online classes. The total number of classes possible is 7, with higher numbers associated with better participation.
Participation in HeartHome intervention calls
Time Frame: 12 weeks post HeartHome intervention start
Participation in HeartHome's calls will be measured by the number of calls that each participant attends relative to the total number of calls. The total number of calls possible is 8, with higher rate associated with better participation.
HeartHome intervention weekly goal adherence score
Time Frame: 12 weeks post HeartHome intervention start
Adherence to weekly goals will be measured by participant goal achievement, which includes 33 opportunities for goal achievement and progression. The range is 0-33, with higher scores associated with greater adherence to weekly goals.
Number of sessions completed.
Time Frame: 13-weeks post start of HeartHome and control intervention
Sessions completed by participants will be measured by the total number of calls, interactive online classes, and in-person visits attended. The total number of sessions is 20, with higher numbers associated with higher participation. Sessions completed by the control group will be measured by the total number of exercise sessions and classes attended. The total number of sessions for the control group is 46, with higher numbers associated with higher participation.
Secondary Outcomes
- HeartHome participants' physical function at baseline and at week 12(12 weeks post start of HeartHome intervention)
- Change in HeartHome participant's physical functioning, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.(12- and 24-weeks post start of intervention)
- 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.(12- and 24- weeks post start of intervention)
- 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.(12- and 24- weeks post start of intervention)
- Change in HeartHome participant's energy/fatigue, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.(12- and 24- weeks post start of intervention)
- HeartHome participant's emotional well-being, sub score of RAND SF-36, assessed at baseline, week 12, and week 24.(12- and 24-weeks post start of intervention)
- HeartHome participant's social functioning, sub score of RAND SF-36, evaluated at baseline, week 12, and week 24.(12- and 24-weeks post start of intervention)
- HeartHome participant's bodily pain, a sub score of RAND SF-36, will be evaluated at baseline, week 12 and week 24.(12- and 24- weeks post start of intervention)
- HeartHome participant's general health, sub score of RAND SF-36 at baseline, week 12, and week 24.(12- and 24-weeks post start of intervention)
- 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(13-weeks post start of HeartHome and control intervention)
- HeartHome participant's blood pressure at baseline and weeks 3, 5, 7 and 12.(Baseline, weeks 3, 5, 7, and 12 of intervention)
- Participants' and control's blood pressure at baseline and 12 weeks(Baseline and 13-weeks post start of HeartHome and control intervention)
- Change in HeartHome participant's reported nicotine use from baseline to week 12 and baseline to week 24.(12- and 24-weeks post start of intervention)
- HeartHome participant's waist circumference from baseline to week 12.(12 weeks post start of intervention)
- HeartHome participant's Body Mass Index at baseline and week 12.(Baseline and 12 weeks post start of intervention)
- Change of HeartHome participants' and control Body Mass Index from baseline to week 12(Baseline and 13-weeks post start of HeartHome and control intervention)
- HeartHome participant's average weekly steps walked from baseline to week 12.(12 weeks post start of intervention)
- HeartHome participant's self-Reported and medical record reviewed number of hospital admissions 12 and 24 weeks after beginning of heart home program.(12- and 24- weeks post start of intervention)
- HeartHome participant's self-Reported and medical record reviewed number of days hospitalized 12 and 24 weeks after beginning of heart home program.(12- and 24- weeks post start of intervention)
- HeartHome participant and control number of hospital readmissions at 12 weeks(13-weeks post start of HeartHome and control intervention)
- 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(12- and 24- weeks post start of intervention)
- HeartHome participant's self-reported and medical record reviewed number of specialist visits 12 and 24 weeks after beginning of the HeartHome program(12- and 24- weeks post start of intervention)
- HeartHome participant's self-reported and medical record reviewed number of primary care visits 12 and 24 weeks after beginning of the HeartHome program(12- and 24- weeks post start of intervention)
- HeartHome participant's self-reported and medical record reviewed number of urgent care visits 12 and 24 weeks after beginning of the HeartHome program(12- and 24- weeks post start of intervention)
- HeartHome participant's Morisky 4-Item Scale scores at baseline, week 12, and week 24.(12- and 24-weeks post start of intervention)
- HeartHome participant's change in perceived stress scale from baseline to week 12 and baseline to week 24.(12 and 24 weeks post start of intervention)
- HeartHome participant's change in dietary risk assessment from baseline to week 12 and baseline to week 24.(12- and 24- weeks post start of intervention)
- Participants' and control's dietary risk assessment scores from baseline to week 12 to dietary risk assessment scores of control group.(13-weeks post start of HeartHome and control intervention)
- HeartHome participant's change in PHQ-9 from baseline to week 12.(12 weeks post start of intervention)
- Change in participants' and control's PHQ-9 from baseline to week 12.(13-weeks post start of HeartHome and control intervention)
- HeartHome participant's change in New General Self-Efficacy score from baseline to week 12 and baseline to week 24.(12- and 24-weeks post start of intervention)
- HeartHome participant's change in knowledge of cardiac rehabilitation from baseline to 12 weeks and baseline to 24 weeks.(12- and 24-weeks post start of intervention)
- Participants' and control's change in knowledge of cardiac rehabilitation from baseline to 12 weeks.(13-weeks post start of HeartHome and control intervention)