Heart Failure, Congestive
Conditions
Brief summary
Non-adherence to the heart failure (HF) plan of care after hospital discharge has been associated with clinical outcomes, including the combined endpoint of all-cause mortality and rehospitalization for decompensated HF. Patients and informal caregivers receive education materials but may not act due to multiple factors. A recorded message that could be repeatedly played by patients and caregivers might increase adherence to post-discharge self-care behaviors and early follow-up appointments, and have clinical benefits related to a reduction in all-cause mortality and rehospitalization. The purposes of this randomized, controlled study are to examine the effects of use of a novel MyROAD (Recordable On-Demand Audio Discharge) card, given to patients at discharge. The aims of this single-blind, placebo-controlled study are to examine the effects of recorded messages that can be replayed post discharge (delivered via the MyROAD card) on multiple subjective and objective clinical outcomes.
Detailed description
Non-adherence to the heart failure (HF) plan of care after hospital discharge has been associated with clinical outcomes, including the combined endpoint of all-cause mortality and rehospitalization for decompensated heart failure. Most patients are discharged with a complex set of instructions that include multiple medications (and differing mediation administration plans), sodium restricted diet, fluid management actions (daily weight monitoring and in some cases, fluid restriction), monitoring signs and symptoms of HF, activity and exercise, and when to return for follow-up. At discharge, patients (and their families) may not understand that heart failure is chronic. Improvement in quality of life may be dependent on patients' acceptance of HF as a chronic, irreversible condition that requires self-care monitoring and behaviors (for example, becoming or staying physically active), even when they feel fine. To decrease the complexity of understanding heart failure, patients receive a heart failure handbook and a zones 1-page handout before discharge. In addition, they can watch multiple video clips of many heart failure topics and discuss heart failure self-care with the hospital healthcare team. However, patients may not read (or view) education materials due to health literacy issues, cognitive decline, eyesight issues, fatigue, or depression. Patients may rely on lay (family) caregivers to understand self-car expectations and be active partners in care. Caregivers engaged in patients' care may not be present at discharge or may have preconceived or inaccurate ideas about heart failure self-care after discharge. A recorded message that could be repeatedly played by patients and caregivers might increase adherence to post-discharge self-care behaviors and 7-day follow-up appointments, and have clinical benefits related to a reduction in all-cause mortality and rehospitalization. The purpose of this randomized, controlled study are to examine the effects of use of a novel MyROAD (Recordable On-Demand Audio Discharge) card, given to patients at discharge. The aims of this single-blind, placebo-controlled study are to examine the effects of recorded messages that can be replayed post discharge (delivered via the MyROAD card) on (1) 45-, 90-, and 180-day first occurrence and (2) time to first occurrence of all-cause and HF-related hospitalization, emergency department visits and death/ cardiac transplantation/ventricular assist device, (3) 45-day quality of life (Kansas City Cardiomyopathy Questionnaire), symptoms (investigator initiated tool; used in previous research), functional status (Duke Activity Status Index) and perceived adherence to activity recommendations (investigator initiated tool; used in previous research), and (4) 7-day follow-up appointment with the healthcare provider assigned before discharge. A total of 1066 patients (968 + 10% attrition) with decompensated heart failure will be randomized to either usual care or usual care and receiving a MyROAD card at discharge.
Interventions
OTHERon-demand audio messages of heart failure education themes
Sponsors
American Greetings
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Intervention model description
usual care education versus education with a pre-recorded card with heart failure instructions
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Not referred for cardiac transplantation or ventricular assist device during the index hospitalization, * Minimum age 18 years (no upper age limit), * Ability to read and write, * Discharge to home or to a family member's home and has control of making self-care decisions, * Willing to participate; which requires three (3) follow-up telephone calls post-discharge.
Exclusion criteria
* Chart documented psychiatric or cognitive conditions that limit ability to understand or adhere to self-care recommendations (Alzheimer's condition, dementia, schizophrenia, other neurological history that impairs memory), * Plans to discharge to assisted living apartment/center, skilled nursing facility or hospice care center, * Receiving home hospice or palliative care; or has a medical condition reflecting less than 1 year of survival (cachexia, end stage liver disease or cancer or non-ambulatory New York Heart Association functional class IV heart failure), * Post-cardiac transplantation or ventricular assist device placement, * Currently enrolled in another experimental heart failure research study, * Chronic renal failure and receiving chronic hemodialysis therapy for an estimated glomerular filtration rate \< 30 mL/minute/1.73 m2, * A non-traditional form of heart failure (hypertrophic or restrictive forms of cardiomyopathy, congenital heart disease or Takotsubo cardiomyopathy). * Wheelchair bound, uses a cane or walker, or unable to carry out physical activity, including walking,due to a chronic disability or documented medical condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Rehospitalized With Heart Failure | 30 day | Number of patients re-hospitalized with heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (Health Status) | Baseline | Quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire that measures physical limitations, symptoms, self-efficacy, social interference and quality of life. The KCCQ is a standardized score from 0 to 100 points. A score of 0 is the lowest quality of life (poor) and score of 100 is the highest quality of life. |
| Symptoms | Baseline | 29-item list of heart failure-related symptoms. Patients were asked to consider any symptoms they experienced in the last 2 weeks and choose all that apply. Patients could also check do not weigh self and no signs or symptoms of anything abnormal. The median \[Q1, Q3\] number of symptoms was reported between groups. |
| Functional Status | Baseline | Duke Activity Status Index (DASI) is a 12-item questionnaire using Likert scale that determines a patient's ability to participate in common, everyday activities without difficulty including self-care activities (e.g., ambulation, housework, yard work, sexual relations, and recreational activities. This is a patient-reported tool that measures functional status in patients with heart failure. Scores range from 0 (no functional capacity = worst score) to 58.2 (highest functional capacity = best score). |
| Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge | Discharge from hospital | Adherence to 7-day follow-up appointment with a healthcare provider; by medical record chart review |
| Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome) | 90 days | All-cause re-hospitalization, death, left ventricular assist device (LVAD), or cardiac transplant via medical record chart review; interview (telephone call). |
| Number of Patients Rehospitalized With Heart Failure | 45 days | Number of patients rehospitalized with heart failure via chart review; interview (telephone call). |
| Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit | 180 days | Number of patients with all-cause rehospitalization, death, or emergency department visits within 180 days. Information is obtained via medical record chart review. |
| Adherence to Activity Recommendations | Baseline | Modified PACE tool; used in previous research. Patients were asked to self-report their perceived adherence to activity recommendations by selecting the option on a checklist that matched their activity level. |
Countries
United States
Participant flow
Recruitment details
Adults with decompensated heart failure HF with preserved or reduced ejection fraction when hospitalized and New York Heart Association FC III or ambulatory IV. Dates of enrollment occurred between March 2016 to June 2019.
Pre-assignment details
Of the 2487 patients enrolled, 1073 met inclusion criteria and were randomized to either usual care or usual care + intervention (My Recordable On-Demand Audio Discharge Instructions MyROAD card).
Participants by arm
| Arm | Count |
|---|---|
| MyRoad Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes | 506 |
| Usual Care Receives usual care heart failure education before discharge | 491 |
| Total | 997 |
Baseline characteristics
| Characteristic | MyRoad | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 11.2 | 73.1 years STANDARD_DEVIATION 11 | 72.8 years STANDARD_DEVIATION 11.1 |
| Cardiac devices at admission or before hospital discharge AAI pacemaker (single chamber pacemaker operates in AAI mode) | 3 Participants | 2 Participants | 5 Participants |
| Cardiac devices at admission or before hospital discharge CRT (Cardiac Resynchronization Therapy) | 9 Participants | 6 Participants | 15 Participants |
| Cardiac devices at admission or before hospital discharge CRT-D (Cardiac Resynchronization Therapy with Pacemaker) | 45 Participants | 33 Participants | 78 Participants |
| Cardiac devices at admission or before hospital discharge DDD pacemaker (dual-chamber pacemaker) | 27 Participants | 28 Participants | 55 Participants |
| Cardiac devices at admission or before hospital discharge ICD (Implantable Cardioverter Defibrillator) | 88 Participants | 84 Participants | 172 Participants |
| Cardiac devices at admission or before hospital discharge None | 332 Participants | 333 Participants | 665 Participants |
| Cardiac devices at admission or before hospital discharge Other | 2 Participants | 5 Participants | 7 Participants |
| Charlson Comorbidity Index >1.5 but <2.5 | 193 Participants | 163 Participants | 356 Participants |
| Charlson Comorbidity Index >2.5 but <3.5 | 140 Participants | 161 Participants | 301 Participants |
| Charlson Comorbidity Index >3.5 but <4.5 | 97 Participants | 86 Participants | 183 Participants |
| Charlson Comorbidity Index >4.5 but <6.5 | 65 Participants | 65 Participants | 130 Participants |
| Charlson Comorbidity Index >6.5 | 11 Participants | 16 Participants | 27 Participants |
| Consider how well you live on income Comfortable, more than enough | 158 Participants | 137 Participants | 295 Participants |
| Consider how well you live on income Do not have enough to make ends meet | 124 Participants | 122 Participants | 246 Participants |
| Consider how well you live on income Have enough to make ends meet | 224 Participants | 232 Participants | 456 Participants |
| Do you currently live with another person? No | 116 Participants | 117 Participants | 233 Participants |
| Do you currently live with another person? Yes | 390 Participants | 374 Participants | 764 Participants |
| Do you have someone to confide in? Missing survey response | 1 Participants | 0 Participants | 1 Participants |
| Do you have someone to confide in? No | 13 Participants | 9 Participants | 22 Participants |
| Do you have someone to confide in? Yes | 492 Participants | 482 Participants | 974 Participants |
| Drug classes at discharge Aldosterone antagonist | 136 Participants | 129 Participants | 265 Participants |
| Drug classes at discharge Angiotensin-converting enzyne inhibitors (ACE-i) | 145 Participants | 117 Participants | 262 Participants |
| Drug classes at discharge Angiotensin receptor blocker (ARB) | 67 Participants | 58 Participants | 125 Participants |
| Drug classes at discharge Angiotensin receptor neprilysin inhibitor (ARNI) | 29 Participants | 15 Participants | 44 Participants |
| Drug classes at discharge Beta blocker | 398 Participants | 401 Participants | 799 Participants |
| Drug classes at discharge Digoxin | 77 Participants | 68 Participants | 145 Participants |
| Drug classes at discharge Hydralazine | 87 Participants | 103 Participants | 190 Participants |
| Drug classes at discharge Loop diuretic | 457 Participants | 449 Participants | 906 Participants |
| Drug classes at discharge Nitrate | 150 Participants | 171 Participants | 321 Participants |
| Drug classes at discharge Sinus node funny channel inhibitor | 1 Participants | 0 Participants | 1 Participants |
| Drug classes at discharge Statin | 321 Participants | 328 Participants | 649 Participants |
| Drug classes at discharge Thiazide or Thiazide like diuretic | 15 Participants | 28 Participants | 43 Participants |
| Ejection fraction % | 41.3 % of blood ejected with each contraction STANDARD_DEVIATION 17.2 | 42.0 % of blood ejected with each contraction STANDARD_DEVIATION 16.8 | 41.6 % of blood ejected with each contraction STANDARD_DEVIATION 17 |
| Employment status Employed full or part-time | 60 Participants | 61 Participants | 121 Participants |
| Employment status Other | 0 Participants | 1 Participants | 1 Participants |
| Employment status Retired due to HF | 60 Participants | 51 Participants | 111 Participants |
| Employment status Retired, not due to HF | 318 Participants | 310 Participants | 628 Participants |
| Employment status Sick leave or disability | 46 Participants | 57 Participants | 103 Participants |
| Employment status Unemployed by choice | 22 Participants | 11 Participants | 33 Participants |
| Health care services When was last time you were in hospital for your heart, but not heart failure Don't remember or never been in hospital | 10 Participants | 12 Participants | 22 Participants |
| Health care services When was last time you were in hospital for your heart, but not heart failure Left the hospital 2 weeks ago (8-14 days ago) | 24 Participants | 15 Participants | 39 Participants |
| Health care services When was last time you were in hospital for your heart, but not heart failure Left the hospital 3-4 weeks ago (15-30 days ago) | 27 Participants | 21 Participants | 48 Participants |
| Health care services When was last time you were in hospital for your heart, but not heart failure Left the hospital over 1 month ago but <3 months ago | 78 Participants | 85 Participants | 163 Participants |
| Health care services When was last time you were in hospital for your heart, but not heart failure Left the hospital within the last 7 days | 15 Participants | 12 Participants | 27 Participants |
| Health care services When was last time you were in hospital for your heart, but not heart failure Longer than 3 months ago | 352 Participants | 346 Participants | 698 Participants |
| Health care services When was the last time you were hospitalized for heart failure? Don't remember or never been in hospital | 2 Participants | 5 Participants | 7 Participants |
| Health care services When was the last time you were hospitalized for heart failure? Left the hospital 2 weeks ago (8-14 days ago) | 36 Participants | 32 Participants | 68 Participants |
| Health care services When was the last time you were hospitalized for heart failure? Left the hospital 3-4 weeks ago (15-30 days ago) | 50 Participants | 36 Participants | 86 Participants |
| Health care services When was the last time you were hospitalized for heart failure? Left the hospital over 1 month ago but <3 months ago | 90 Participants | 97 Participants | 187 Participants |
| Health care services When was the last time you were hospitalized for heart failure? Left the hospital within the last 7 days | 28 Participants | 29 Participants | 57 Participants |
| Health care services When was the last time you were hospitalized for heart failure? Longer than 3 months ago | 300 Participants | 292 Participants | 592 Participants |
| Health care services When was the last time you were in hospital for any reason? Don't remember or never been in hospital | 0 Participants | 0 Participants | 0 Participants |
| Health care services When was the last time you were in hospital for any reason? Left the hospital 2 weeks ago (8-14 days ago) | 50 Participants | 40 Participants | 90 Participants |
| Health care services When was the last time you were in hospital for any reason? Left the hospital 3-4 weeks ago (15-30 days ago) | 59 Participants | 43 Participants | 102 Participants |
| Health care services When was the last time you were in hospital for any reason? Left the hospital over 1 month ago but <3 months ago | 125 Participants | 126 Participants | 251 Participants |
| Health care services When was the last time you were in hospital for any reason? Left the hospital within the last 7 days | 33 Participants | 34 Participants | 67 Participants |
| Health care services When was the last time you were in hospital for any reason? Longer than 3 months ago | 239 Participants | 248 Participants | 487 Participants |
| Heart failure etiology Alcoholic | 7 Participants | 3 Participants | 10 Participants |
| Heart failure etiology Chemotherapy | 2 Participants | 7 Participants | 9 Participants |
| Heart failure etiology Hypertensive | 49 Participants | 42 Participants | 91 Participants |
| Heart failure etiology Idiopathic | 97 Participants | 101 Participants | 198 Participants |
| Heart failure etiology Ischemic | 265 Participants | 259 Participants | 524 Participants |
| Heart failure etiology Other | 3 Participants | 2 Participants | 5 Participants |
| Heart failure etiology Postpardum | 1 Participants | 0 Participants | 1 Participants |
| Heart failure etiology Valvular heart disease | 82 Participants | 77 Participants | 159 Participants |
| Highest level of education completed Associate degree | 17 Participants | 20 Participants | 37 Participants |
| Highest level of education completed Bachelor's degree | 61 Participants | 47 Participants | 108 Participants |
| Highest level of education completed Doctoral degree | 8 Participants | 13 Participants | 21 Participants |
| Highest level of education completed General Educational Development (GED) | 8 Participants | 9 Participants | 17 Participants |
| Highest level of education completed High school graduate | 182 Participants | 172 Participants | 354 Participants |
| Highest level of education completed Less than high school graduate | 75 Participants | 69 Participants | 144 Participants |
| Highest level of education completed Master's degree | 24 Participants | 18 Participants | 42 Participants |
| Highest level of education completed Some college or professional training post high school | 131 Participants | 143 Participants | 274 Participants |
| In general, would you say your health is Excellent | 10 Participants | 11 Participants | 21 Participants |
| In general, would you say your health is Fair | 200 Participants | 222 Participants | 422 Participants |
| In general, would you say your health is Good | 138 Participants | 110 Participants | 248 Participants |
| In general, would you say your health is Poor | 135 Participants | 119 Participants | 254 Participants |
| In general, would you say your health is Very good | 23 Participants | 29 Participants | 52 Participants |
| Location Fairview | 73 Participants | 66 Participants | 139 Participants |
| Location Hillcrest | 115 Participants | 116 Participants | 231 Participants |
| Location Main campus | 288 Participants | 282 Participants | 570 Participants |
| Location Medina | 30 Participants | 27 Participants | 57 Participants |
| Marital status Co-habitate (living with partner) | 11 Participants | 6 Participants | 17 Participants |
| Marital status Divorced/Separated | 66 Participants | 67 Participants | 133 Participants |
| Marital status Married | 255 Participants | 239 Participants | 494 Participants |
| Marital status Single | 66 Participants | 75 Participants | 141 Participants |
| Marital status Widowed | 108 Participants | 104 Participants | 212 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 123 Participants | 120 Participants | 243 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) White | 375 Participants | 362 Participants | 737 Participants |
| Region of Enrollment United States | 506 participants | 491 participants | 997 participants |
| Sex: Female, Male Female | 206 Participants | 206 Participants | 412 Participants |
| Sex: Female, Male Male | 300 Participants | 285 Participants | 585 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Patients Rehospitalized With Heart Failure
Number of patients re-hospitalized with heart failure.
Time frame: 30 day
Population: Some patients were not included in the 30 day data due to heart failure related death, LVAD, or heart transplant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MyRoad | Number of Patients Rehospitalized With Heart Failure | Rehospitalized | 71 Participants |
| MyRoad | Number of Patients Rehospitalized With Heart Failure | Not rehospitalized | 425 Participants |
| Usual Care | Number of Patients Rehospitalized With Heart Failure | Rehospitalized | 78 Participants |
| Usual Care | Number of Patients Rehospitalized With Heart Failure | Not rehospitalized | 397 Participants |
Secondary
Adherence to Activity Recommendations
Modified PACE tool; used in previous research. Patients were asked to self-report their perceived adherence to activity recommendations by selecting the option on a checklist that matched their activity level.
Time frame: Baseline
Population: Patients enrolled in the study were later excluded (e.g., due to death, discharged to a Skilled Nursing Facility, dialysis, or left ventricular assist device).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MyRoad | Adherence to Activity Recommendations | Walk 3-5 days/week <10 minutes | 7 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 6-7 days/week for 10-20 minutes | 7 Participants |
| MyRoad | Adherence to Activity Recommendations | I've been thinking of starting | 207 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 6-7 days/week >20 minutes | 6 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 3-5 days/week for 10-20 minutes | 15 Participants |
| MyRoad | Adherence to Activity Recommendations | Began moderate or vigorous exercise <3 x week | 5 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 2/week >10 minutes | 12 Participants |
| MyRoad | Adherence to Activity Recommendations | Moderate exercise 3+ per week the last 1-6 months | 6 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 3-5 days/week >20 minutes | 7 Participants |
| MyRoad | Adherence to Activity Recommendations | Moderate exercise 3+ week for 7 months | 8 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 2/week <10 minutes | 17 Participants |
| MyRoad | Adherence to Activity Recommendations | Vigorous exercise 3-5 week for 1-6 months | 1 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 6-7 days/week <10 minutes | 2 Participants |
| MyRoad | Adherence to Activity Recommendations | Vigorous exercise 3-5 week >12 months | 2 Participants |
| MyRoad | Adherence to Activity Recommendations | I do not walk now | 164 Participants |
| Usual Care | Adherence to Activity Recommendations | Vigorous exercise 3-5 week >12 months | 0 Participants |
| Usual Care | Adherence to Activity Recommendations | I do not walk now | 165 Participants |
| Usual Care | Adherence to Activity Recommendations | I've been thinking of starting | 176 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 2/week <10 minutes | 14 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 2/week >10 minutes | 16 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 3-5 days/week <10 minutes | 11 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 3-5 days/week for 10-20 minutes | 6 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 3-5 days/week >20 minutes | 12 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 6-7 days/week <10 minutes | 3 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 6-7 days/week for 10-20 minutes | 8 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 6-7 days/week >20 minutes | 4 Participants |
| Usual Care | Adherence to Activity Recommendations | Began moderate or vigorous exercise <3 x week | 3 Participants |
| Usual Care | Adherence to Activity Recommendations | Moderate exercise 3+ per week the last 1-6 months | 8 Participants |
| Usual Care | Adherence to Activity Recommendations | Moderate exercise 3+ week for 7 months | 6 Participants |
| Usual Care | Adherence to Activity Recommendations | Vigorous exercise 3-5 week for 1-6 months | 1 Participants |
Secondary
Adherence to Activity Recommendations
Modified PACE tool; used in previous research. Patient's were contacted by telephone and asked to self-report their perceived adherence to activity recommendations.
Time frame: 45 day
Population: Patients enrolled in the study were later excluded (e.g., due to death, discharged to Skilled Nursing Facility, dialysis, or left ventricular assist device).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MyRoad | Adherence to Activity Recommendations | Walk 6-7 days/week <10 minutes | 11 Participants |
| MyRoad | Adherence to Activity Recommendations | I do not walk now | 186 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 6-7 days/week for 10-20 minutes | 10 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 3-5 days/week <10 minutes | 15 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 6-7 days/week >20 minutes | 10 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 2/week <10 minutes | 8 Participants |
| MyRoad | Adherence to Activity Recommendations | Began moderate or vigorous exercise <3 x week | 10 Participants |
| MyRoad | Adherence to Activity Recommendations | Moderate exercise 3+ per week the last 1-6 months | 12 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 3-5 days/week for 10-20 minutes | 20 Participants |
| MyRoad | Adherence to Activity Recommendations | Moderate exercise 3+ week for 7 months | 3 Participants |
| MyRoad | Adherence to Activity Recommendations | I've been thinking of starting | 162 Participants |
| MyRoad | Adherence to Activity Recommendations | Vigorous exercise 3-5 week for 1-6 months | 1 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 3-5 days/week >20 minutes | 6 Participants |
| MyRoad | Adherence to Activity Recommendations | Vigorous exercise 3-5 week >12 months | 1 Participants |
| MyRoad | Adherence to Activity Recommendations | Walk 2/week >10 minutes | 12 Participants |
| Usual Care | Adherence to Activity Recommendations | Vigorous exercise 3-5 week >12 months | 0 Participants |
| Usual Care | Adherence to Activity Recommendations | I do not walk now | 161 Participants |
| Usual Care | Adherence to Activity Recommendations | I've been thinking of starting | 148 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 2/week <10 minutes | 7 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 2/week >10 minutes | 11 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 3-5 days/week <10 minutes | 17 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 3-5 days/week for 10-20 minutes | 14 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 3-5 days/week >20 minutes | 11 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 6-7 days/week <10 minutes | 10 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 6-7 days/week for 10-20 minutes | 20 Participants |
| Usual Care | Adherence to Activity Recommendations | Walk 6-7 days/week >20 minutes | 8 Participants |
| Usual Care | Adherence to Activity Recommendations | Moderate exercise 3+ per week the last 1-6 months | 14 Participants |
| Usual Care | Adherence to Activity Recommendations | Moderate exercise 3+ week for 7 months | 4 Participants |
| Usual Care | Adherence to Activity Recommendations | Vigorous exercise 3-5 week for 1-6 months | 0 Participants |
| Usual Care | Adherence to Activity Recommendations | Began moderate or vigorous exercise <3 x week | 8 Participants |
Secondary
Functional Status
Duke Activity Status Index (DASI) is a 12-item questionnaire using Likert scale that determines a patient's ability to participate in common, everyday activities without difficulty including self-care activities (e.g., ambulation, housework, yard work, sexual relations, and recreational activities. This is a patient-reported tool that measures functional status in patients with heart failure. Scores range from 0 (no functional capacity = worst score) to 58.2 (highest functional capacity = best score).
Time frame: Baseline
Population: Patients enrolled in the study were later excluded (e.g., due to death, discharged to Skilled Nursing Facility, dialysis, or left ventricular assist device).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyRoad | Functional Status | 19.7 score on a scale | Standard Deviation 11.1 |
| Usual Care | Functional Status | 19.0 score on a scale | Standard Deviation 10.6 |
Secondary
Functional Status
Duke Activity Status Index (DASI) is a 12-item questionnaire. This is a patient-reported tool that measures functional status in patients with heart failure. Patients were called by telephone and asked to rate their ability to do daily activities (e.g., personal care, ambulation, household tasks, sexual function, and recreation). Scores range from 0 (no functional capacity = worst score) to 58.2 (highest functional capacity = best score).
Time frame: 45 day
Population: The number analyzed in both groups was lower than the number enrolled due to being unable to reach patients by phone or the patient was deceased (medical record chart review).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyRoad | Functional Status | 18.1 score on a scale | Standard Deviation 10.5 |
| Usual Care | Functional Status | 18.3 score on a scale | Standard Deviation 10.8 |
Secondary
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
All-cause re-hospitalization, death, left ventricular assist device (LVAD), or cardiac transplant via medical record chart review; interview (telephone call).
Time frame: 180 days
Population: The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record or the patient was deceased.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyRoad | Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome) | 331 Participants |
| Usual Care | Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome) | 322 Participants |
Secondary
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
All-cause re-hospitalization, death, left ventricular assist device (LVAD), or cardiac transplant via medical record chart review; interview (telephone call).
Time frame: 90 days
Population: The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record or the patient was deceased.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyRoad | Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome) | 243 Participants |
| Usual Care | Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome) | 262 Participants |
Secondary
Number of Patients Rehospitalized With Heart Failure
Number of patients rehospitalized with heart failure via chart review; interview (telephone call).
Time frame: 180 days
Population: The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record chart.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MyRoad | Number of Patients Rehospitalized With Heart Failure | 192 participants |
| Usual Care | Number of Patients Rehospitalized With Heart Failure | 183 participants |
Secondary
Number of Patients Rehospitalized With Heart Failure
Number of patients rehospitalized with heart failure via chart review; interview (telephone call).
Time frame: 45 days
Population: The number analyzed in both groups was lower than the number enrolled due to being unable to reach patients by phone for follow-up or the patient was deceased.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyRoad | Number of Patients Rehospitalized With Heart Failure | 91 Participants |
| Usual Care | Number of Patients Rehospitalized With Heart Failure | 104 Participants |
Secondary
Number of Patients Rehospitalized With Heart Failure
Number of patients rehospitalized with heart failure via chart review
Time frame: 90 days
Population: The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record chart.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyRoad | Number of Patients Rehospitalized With Heart Failure | 135 Participants |
| Usual Care | Number of Patients Rehospitalized With Heart Failure | 138 Participants |
Secondary
Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge
Adherence to 7-day follow-up appointment with a healthcare provider; by medical record chart review
Time frame: Discharge from hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyRoad | Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge | 290 Participants |
| Usual Care | Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge | 285 Participants |
Secondary
Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit
Number of patients with all-cause rehospitalization, death, or emergency department visits within 180 days. Information is obtained via medical record chart review.
Time frame: 180 days
Population: patients enrolled and discharged from the hospital alive; that we were able to obtain 180 day data on, assessed treatment group compared to usual care group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyRoad | Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit | 331 Participants |
| Usual Care | Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit | 322 Participants |
Secondary
Quality of Life (Health Status)
Quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire that measures physical limitations, symptoms, self-efficacy, social interference and quality of life. The KCCQ is a standardized score from 0 to 100 points. A score of 0 is the lowest quality of life (poor) and score of 100 is the highest quality of life.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyRoad | Quality of Life (Health Status) | 46.1 score on a scale | Standard Deviation 17 |
| Usual Care | Quality of Life (Health Status) | 45.5 score on a scale | Standard Deviation 17.3 |
Secondary
Quality of Life (Health Status)
Quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire that measures physical limitations, symptoms, self-efficacy, social interference and quality of life. The KCCQ is a standardized score from 0 to 100 points. A score of 0 is the lowest quality of life (poor) and score of 100 is the highest quality of life.
Time frame: 45 day
Population: The number analyzed in both groups was lower than the number enrolled due to being unable to reach patients by phone for follow-up or the patient was deceased.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyRoad | Quality of Life (Health Status) | 62.6 score on a scale | Standard Deviation 21.4 |
| Usual Care | Quality of Life (Health Status) | 64.5 score on a scale | Standard Deviation 22.5 |
Secondary
Symptoms
29-item list of heart failure-related symptoms. Patients were asked to consider any symptoms they experienced in the last 2 weeks and choose all that apply. Patients could also check do not weigh self and no signs or symptoms of anything abnormal. The median \[Q1, Q3\] number of symptoms was reported between groups.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MyRoad | Symptoms | 8.0 Symptoms |
| Usual Care | Symptoms | 8.0 Symptoms |
Secondary
Symptoms
29-item list of heart failure-related symptoms. Patients were asked to consider any symptoms they experienced in the last 2 weeks and choose all that apply. Patients could also check do not weigh self and no signs or symptoms of anything abnormal. The median \[Q1, Q3\] number of symptoms was reported between groups.
Time frame: 45 days
Population: The number analyzed in both groups was lower than the number enrolled due to being unable to reach patients by phone for follow-up or the patient was deceased.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MyRoad | Symptoms | 4.0 Symptoms |
| Usual Care | Symptoms | 4.0 Symptoms |