- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131816
HeartHome: A Nurse-Driven, Home-Based Cardiac Rehabilitation Program
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- UNC Health Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HeartHome Intervention
Participants will be in the HeartHome program for a total of 12 weeks.
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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.
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No Intervention: Control
De-identified data from 150 patients who attend a traditional cardiac rehabilitation program during the same general time of the HeartHome implementation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of HeartHome patient referrals into the HeartHome program
Time Frame: 10 months after beginning of study
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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.
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10 months after beginning of study
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Proportion of HeartHome patient referral into the HeartHome program
Time Frame: 10 months after beginning of study
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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.
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10 months after beginning of study
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Proportion of HeartHome patient enrollments in the HeartHome program
Time Frame: 10 months after beginning of study
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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.
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10 months after beginning of study
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Participation in HeartHome's participants in-person visits
Time Frame: 12 weeks post HeartHome intervention start
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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.
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12 weeks post HeartHome intervention start
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Participation in HeartHome's participants interactive online classes
Time Frame: 12 weeks post HeartHome intervention start
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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.
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12 weeks post HeartHome intervention start
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Participation in HeartHome intervention calls
Time Frame: 12 weeks post HeartHome intervention start
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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.
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12 weeks post HeartHome intervention start
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HeartHome intervention weekly goal adherence score
Time Frame: 12 weeks post HeartHome intervention start
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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.
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12 weeks post HeartHome intervention start
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Number of sessions completed.
Time Frame: 13-weeks post start of HeartHome and control intervention
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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.
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13-weeks post start of HeartHome and control intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HeartHome participants' physical function at baseline and at week 12
Time Frame: 12 weeks post start of HeartHome intervention
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HeartHome participants' physical function will be measured by the six-minute walk distances at baseline and at 12 weeks.
Longer distances (in meters) are associated with higher physical function.
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12 weeks post start of HeartHome intervention
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Change in HeartHome participant's physical functioning, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.
Time Frame: 12- and 24-weeks post start of intervention
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Change in participants' physical function will be measured by a sub score of the RAND Short Form Survey Instrument (SF-36).
The range is 0 - 100, and higher scores are associated with better physical function.
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12- and 24-weeks post start of intervention
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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.
Time Frame: 12- and 24- weeks post start of intervention
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Change in participants' role limitations due to physical health will be measured by a sub score of the RAND Short Form Survey Instrument (SF-36).
The range is 0 - 100, and higher scores are associated with fewer role limitations due to physical health.
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12- and 24- weeks post start of intervention
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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.
Time Frame: 12- and 24- weeks post start of intervention
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Change in participants' role limitations due to emotional problems will be measured by a sub score of the RAND Short Form Survey Instrument (SF-36).
The range is 0 - 100, and higher scores are associated with fewer role limitations due to emotional problems.
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12- and 24- weeks post start of intervention
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Change in HeartHome participant's energy/fatigue, sub score of RAND SF-36 from baseline to week 12 and baseline to week 24.
Time Frame: 12- and 24- weeks post start of intervention
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Change in participants' energy/fatigue will be measured by a sub score of the RAND Short Form Survey Instrument (SF-36).
The range is 0 - 100, and higher scores are associated with higher energy/lower fatigue.
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12- and 24- weeks post start of intervention
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HeartHome participant's emotional well-being, sub score of RAND SF-36, assessed at baseline, week 12, and week 24.
Time Frame: 12- and 24-weeks post start of intervention
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Participants' emotional well-being will be measured by a sub score of the RAND Short Form Survey Instrument (SF-36).
The range is 0 - 100, and higher scores are associated with better emotional well-being.
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12- and 24-weeks post start of intervention
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HeartHome participant's social functioning, sub score of RAND SF-36, evaluated at baseline, week 12, and week 24.
Time Frame: 12- and 24-weeks post start of intervention
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Participants' social functioning will be measured by a sub score of the RAND Short Form Survey Instrument (SF-36).
The range is 0 - 100, and higher scores are associated with better social functioning.
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12- and 24-weeks post start of intervention
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HeartHome participant's bodily pain, a sub score of RAND SF-36, will be evaluated at baseline, week 12 and week 24.
Time Frame: 12- and 24- weeks post start of intervention
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Participants' bodily pain will be measured by a sub score of the RAND Short Form Survey Instrument (SF-36).
The range is 0 - 100, and higher scores are associated with less pain.
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12- and 24- weeks post start of intervention
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HeartHome participant's general health, sub score of RAND SF-36 at baseline, week 12, and week 24.
Time Frame: 12- and 24-weeks post start of intervention
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Participants' general health will be measured by a sub score of the RAND Short Form Survey Instrument (SF-36).
The range is 0 - 100, and higher scores are associated with better general health.
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12- and 24-weeks post start of intervention
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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
Time Frame: 13-weeks post start of HeartHome and control intervention
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Participants' physical function will be measured by a sub score of the RAND SF-36.
The range is 0-100, and higher scores are associated with better physical functioning.
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13-weeks post start of HeartHome and control intervention
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HeartHome participant's blood pressure at baseline and weeks 3, 5, 7 and 12.
Time Frame: Baseline, weeks 3, 5, 7, and 12 of intervention
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Blood pressure will be measured by blood pressure measurements, measured in mmHg.
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Baseline, weeks 3, 5, 7, and 12 of intervention
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Participants' and control's blood pressure at baseline and 12 weeks
Time Frame: Baseline and 13-weeks post start of HeartHome and control intervention
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Blood pressure will be measured by blood pressure measurements, measured in mmHg.
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Baseline and 13-weeks post start of HeartHome and control intervention
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Change in HeartHome participant's reported nicotine use from baseline to week 12 and baseline to week 24.
Time Frame: 12- and 24-weeks post start of intervention
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Rates of nicotine use will be measured by the change in participant-reported number of cigarettes smoked per week and patient-report of weekly frequency of non-cigarette nicotine use from baseline to week 12, and baseline to week 24.
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12- and 24-weeks post start of intervention
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HeartHome participant's waist circumference from baseline to week 12.
Time Frame: 12 weeks post start of intervention
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Waist circumference will be measured in centimeters at the beginning of the intervention (HeartHome program) and 12 weeks after beginning the intervention (HeartHome program).
Negative changes in waist circumference are associated with greater weight loss.
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12 weeks post start of intervention
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HeartHome participant's Body Mass Index at baseline and week 12.
Time Frame: Baseline and 12 weeks post start of intervention
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Body Mass Index will be calculated from the participants' weights and heights at the beginning of the intervention (HeartHome program) and 12 weeks after beginning the intervention (HeartHome program).
Lower numbers are associated with weight loss, and a patients' healthy range varies by age and gender.
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Baseline and 12 weeks post start of intervention
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Change of HeartHome participants' and control Body Mass Index from baseline to week 12
Time Frame: Baseline and 13-weeks post start of HeartHome and control intervention
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Body Mass Index will be calculated by assessing participant weight and height at the beginning of the intervention (HeartHome program) and 12 weeks after beginning the intervention (HeartHome Program).
Lower numbers are associated with weight loss, and a patients' healthy range varies by age and gender.
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Baseline and 13-weeks post start of HeartHome and control intervention
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HeartHome participant's average weekly steps walked from baseline to week 12.
Time Frame: 12 weeks post start of intervention
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Average steps walked will be calculated using electronic fitness trackers at the beginning of the intervention (HeartHome program) and 12 weeks after beginning the intervention (HeartHome program).
Higher numbers are associated with higher physical activity.
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12 weeks post start of intervention
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HeartHome participant's self-Reported and medical record reviewed number of hospital admissions 12 and 24 weeks after beginning of heart home program.
Time Frame: 12- and 24- weeks post start of intervention
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Participants' days of care utilization will be measured using the self-reported and medical record reviewed number of instances the participant is hospitalized in 12 and 24 weeks after the beginning of the heart home program.
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12- and 24- weeks post start of intervention
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HeartHome participant's self-Reported and medical record reviewed number of days hospitalized 12 and 24 weeks after beginning of heart home program.
Time Frame: 12- and 24- weeks post start of intervention
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Participants' days of care utilization will be measured using the self-reported and medical record reviewed number of combined days the participant spends in the hospital in 12 and 24 weeks after the beginning of the heart home program.
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12- and 24- weeks post start of intervention
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HeartHome participant and control number of hospital readmissions at 12 weeks
Time Frame: 13-weeks post start of HeartHome and control intervention
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Hospital readmission will be measured using patient self-reports and medical record reviews of hospital admissions (yes/no) at 12 weeks after the start of the intervention (HeartHome program).
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13-weeks post start of HeartHome and control intervention
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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
Time Frame: 12- and 24- weeks post start of intervention
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Participants' days of care utilization will be measured using the self-reported and medical record reviewed number of combined visits the participant makes to the Emergency Department (ED) in 12 and 24 weeks after the beginning of the heart home program.
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12- and 24- weeks post start of intervention
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HeartHome participant's self-reported and medical record reviewed number of specialist visits 12 and 24 weeks after beginning of the HeartHome program
Time Frame: 12- and 24- weeks post start of intervention
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Participants' number of specialist visits will be measured using self-reported and medical record reviewed number of combined cardiology visits 12 and 24 weeks after the beginning of the heart home program.
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12- and 24- weeks post start of intervention
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HeartHome participant's self-reported and medical record reviewed number of primary care visits 12 and 24 weeks after beginning of the HeartHome program
Time Frame: 12- and 24- weeks post start of intervention
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Participants' number of primary care visits will be measured using self-reported and medical record reviewed number of combined primary care visits 12 and 24 weeks after the beginning of the heart home program.
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12- and 24- weeks post start of intervention
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HeartHome participant's self-reported and medical record reviewed number of urgent care visits 12 and 24 weeks after beginning of the HeartHome program
Time Frame: 12- and 24- weeks post start of intervention
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Participants' number of urgent care visits will be measured using self-reported and medical record reviewed number of combined urgent care visits 12 and 24 weeks after the beginning of the heart home program.
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12- and 24- weeks post start of intervention
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HeartHome participant's Morisky 4-Item Scale scores at baseline, week 12, and week 24.
Time Frame: 12- and 24-weeks post start of intervention
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Management of participants' medications will be measured using the Morisky 4-item scale, which includes four questions to estimate the risk of medication non-adherence.
The range is 0 to 4, and lower scores are associated with lower levels of medication adherence.
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12- and 24-weeks post start of intervention
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HeartHome participant's change in perceived stress scale from baseline to week 12 and baseline to week 24.
Time Frame: 12 and 24 weeks post start of intervention
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Participants' stress and emotional state will be measured using the perceived stress scale, which includes ten questions about individuals' feelings and thoughts during the last month.
The range is 0-40, and higher scores are associated with higher levels of perceived stress.
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12 and 24 weeks post start of intervention
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HeartHome participant's change in dietary risk assessment from baseline to week 12 and baseline to week 24.
Time Frame: 12- and 24- weeks post start of intervention
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Participants' diet and lifestyle change will be measured by the dietary risk assessment, which includes 33 questions about how many servings of commonly eaten foods that participants eat in a usual day or an average week.
The range is 0-52, higher scores represent a more healthful dietary pattern.
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12- and 24- weeks post start of intervention
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Participants' and control's dietary risk assessment scores from baseline to week 12 to dietary risk assessment scores of control group.
Time Frame: 13-weeks post start of HeartHome and control intervention
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Participants' diet and lifestyle change will be measured by the dietary risk assessment, which includes 33 questions about how many servings of commonly eaten foods that participants eat in a usual day or an average week.
The range is 0-52, higher scores represent a more healthful dietary pattern.
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13-weeks post start of HeartHome and control intervention
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HeartHome participant's change in PHQ-9 from baseline to week 12.
Time Frame: 12 weeks post start of intervention
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Participants' emotional state will be measured by the Patient Health Questionnaire (PHQ)-9, which includes 9 questions for screening, diagnosing, monitoring, and measuring the severity of depression.
The range is 0 to 27, and scores represent cut-points for mild to severe levels of depression.
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12 weeks post start of intervention
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Change in participants' and control's PHQ-9 from baseline to week 12.
Time Frame: 13-weeks post start of HeartHome and control intervention
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Participants' emotional state will be measured by the PHQ-9, which includes 9 questions for screening, diagnosing, monitoring, and measuring the severity of depression.
The range is 0 to 27, and scores represent cut-points for mild to severe levels of depression, with higher scores associated with more severe levels of depression.
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13-weeks post start of HeartHome and control intervention
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HeartHome participant's change in New General Self-Efficacy score from baseline to week 12 and baseline to week 24.
Time Frame: 12- and 24-weeks post start of intervention
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Participants' confidence regarding task and situational performance is measured by the New General Self-Efficacy Scale, which includes 8 questions about participant confidence.
The range is 8 to 40, and higher scores are associated with higher self-efficacy.
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12- and 24-weeks post start of intervention
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HeartHome participant's change in knowledge of cardiac rehabilitation from baseline to 12 weeks and baseline to 24 weeks.
Time Frame: 12- and 24-weeks post start of intervention
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Participants' knowledge of cardiac rehabilitation is measured by a 10-item Cardiac Rehabilitation Knowledge test at baseline, 12 weeks and 24 weeks.
Scores range from 0-10, with higher scores associated with greater knowledge of cardiac rehabilitation.
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12- and 24-weeks post start of intervention
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Participants' and control's change in knowledge of cardiac rehabilitation from baseline to 12 weeks.
Time Frame: 13-weeks post start of HeartHome and control intervention
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Participants' knowledge of cardiac rehabilitation is measured by a 10-item Cardiac Rehabilitation Knowledge test at baseline, 12 weeks and 24 weeks.
Scores range from 0-10, with higher scores associated with greater knowledge of cardiac rehabilitation.
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13-weeks post start of HeartHome and control intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Cheryl Jones, PhD, RN, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-2540
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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