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| Name | Class |
|---|---|
| American Greetings | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyRoad | Experimental | 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. |
|
| Usual care | No Intervention | Receives usual care heart failure education before discharge |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| on-demand audio messages of heart failure education themes | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Rehospitalized With Heart Failure | Number of patients re-hospitalized with heart failure. | 30 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Discharge from hospital |
| Quality of Life (Health Status) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic main campus | Cleveland | Ohio | 44195 | United States | ||
| Cleveland Clinic Fairview Hospital |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Usual Care | Receives usual care heart failure education before discharge |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Rehospitalized With Heart Failure | Number of patients re-hospitalized with heart failure. | Some patients were not included in the 30 day data due to heart failure related death, LVAD, or heart transplant. | Posted | Count of Participants | Participants | 30 day |
|
Not applicable; the intervention was not directly related to patient events that could have occurred after receiving education; therefore no event data were collected
For the 0 participants at risk (e.g., "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy M. Albert, PhD, CCNS, CCHFN, CCRN, NE-BC, FAHA, FCCM, FHFSA, FAAN | Cleveland Clinic | 216-444-7028 | 47028 | albertn@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2016 | Apr 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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usual care education versus education with a pre-recorded card with heart failure instructions
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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. |
| Baseline |
| 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. | 45 day |
| 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. | Baseline |
| 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. | 45 days |
| 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). | Baseline |
| 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). | 45 day |
| 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. | Baseline |
| 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. | 45 day |
| 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). | 90 days |
| 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). | 180 days |
| Number of Patients Rehospitalized With Heart Failure | Number of patients rehospitalized with heart failure via chart review; interview (telephone call). | 45 days |
| Number of Patients Rehospitalized With Heart Failure | Number of patients rehospitalized with heart failure via chart review | 90 days |
| Number of Patients Rehospitalized With Heart Failure | Number of patients rehospitalized with heart failure via chart review; interview (telephone call). | 180 days |
| 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. | 180 days |
| Cleveland |
| Ohio |
| United States |
| Cleveland Clinic Hillcrest hospital | Mayfield Heights | Ohio | 44124 | United States |
| Cleveland Clinic Medina Hospital | Medina | Ohio | United States |
| BG001 | Usual Care | Receives usual care heart failure education before discharge |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital status | Count of Participants | Participants |
|
| Location | Count of Participants | Participants |
|
| Do you currently live with another person? | Count of Participants | Participants |
|
| Do you have someone to confide in? | Count of Participants | Participants |
|
| Highest level of education completed | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Consider how well you live on income | Count of Participants | Participants |
|
| In general, would you say your health is | Count of Participants | Participants |
|
| Health care services | Count of Participants | Participants |
|
| Heart failure etiology | Count of Participants | Participants |
|
| Ejection fraction % | Mean | Standard Deviation | % of blood ejected with each contraction |
|
| Cardiac devices at admission or before hospital discharge | Count of Participants | Participants |
|
| Drug classes at discharge | Count of Participants | Participants |
|
| Charlson Comorbidity Index | The Charlson Comorbidity Index (CCI) is a measurement tool to predict mortality risk based on the number and severity of co-morbidities. Minimum score 0 Maximum score 28 A score of zero indicates no risk and the highest score indicates a higher risk of mortality. | Count of Participants | Participants |
|
Receives usual care heart failure education before discharge |
|
|
| 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 | Posted | Count of Participants | Participants | Discharge from hospital |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 45 day |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | Symptoms | Baseline |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | Symptoms | 45 days |
|
|
|
| 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). | Patients enrolled in the study were later excluded (e.g., due to death, discharged to Skilled Nursing Facility, dialysis, or left ventricular assist device). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 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). | 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). | Posted | Mean | Standard Deviation | score on a scale | 45 day |
|
|
|
| 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. | 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). | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | Patients enrolled in the study were later excluded (e.g., due to death, discharged to Skilled Nursing Facility, dialysis, or left ventricular assist device). | Posted | Count of Participants | Participants | 45 day |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Secondary | Number of Patients Rehospitalized With Heart Failure | Number of patients rehospitalized with heart failure via chart review; interview (telephone call). | 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. | Posted | Count of Participants | Participants | 45 days |
|
|
|
| Secondary | Number of Patients Rehospitalized With Heart Failure | Number of patients rehospitalized with heart failure via chart review | The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record chart. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Number of Patients Rehospitalized With Heart Failure | Number of patients rehospitalized with heart failure via chart review; interview (telephone call). | The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record chart. | Posted | Number | participants | 180 days |
|
|
|
| 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. | 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 | Posted | Count of Participants | Participants | 180 days |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care | Receives usual care heart failure education before discharge | 0 | 0 | 0 | 0 | 0 | 0 |
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| Left the hospital 3-4 weeks ago (15-30 days ago) |
|
| Left the hospital over 1 month ago but <3 months ago |
|
| Longer than 3 months ago |
|
| Don't remember or never been in hospital |
|
| Left the hospital 3-4 weeks ago (15-30 days ago) |
|
| Left the hospital over 1 month ago but <3 months ago |
|
| Longer than 3 months ago |
|
| Don't remember or never been in hospital |
|
| Walk 2/week <10 minutes |
|
| Walk 2/week >10 minutes |
|
| Walk 3-5 days/week <10 minutes |
|
| Walk 3-5 days/week for 10-20 minutes |
|
| Walk 3-5 days/week >20 minutes |
|
| Walk 6-7 days/week <10 minutes |
|
| Walk 6-7 days/week for 10-20 minutes |
|
| Walk 6-7 days/week >20 minutes |
|
| Began moderate or vigorous exercise <3 x week |
|
| Moderate exercise 3+ per week the last 1-6 months |
|
| Moderate exercise 3+ week for 7 months |
|
| Vigorous exercise 3-5 week for 1-6 months |
|
| Vigorous exercise 3-5 week >12 months |
|
| Walk 2/week <10 minutes |
|
| Walk 2/week >10 minutes |
|
| Walk 3-5 days/week <10 minutes |
|
| Walk 3-5 days/week for 10-20 minutes |
|
| Walk 3-5 days/week >20 minutes |
|
| Walk 6-7 days/week <10 minutes |
|
| Walk 6-7 days/week for 10-20 minutes |
|
| Walk 6-7 days/week >20 minutes |
|
| Began moderate or vigorous exercise <3 x week |
|
| Moderate exercise 3+ per week the last 1-6 months |
|
| Moderate exercise 3+ week for 7 months |
|
| Vigorous exercise 3-5 week for 1-6 months |
|
| Vigorous exercise 3-5 week >12 months |
|