Heart Failure; With Decompensation
Conditions
Keywords
video education, self care management, symptom recognition
Brief summary
Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. Investigators will determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related HCRU.
Detailed description
The most frequently cited danger signs of heart failure (HF) are new onset or worsening of fatigue, dyspnea and edema. In previous research, patients did not recognize worsening HF, due to 3 primary reasons: (1) danger signs were non-specific and misinterpreted as stress, an external force or another comorbidity, (2) danger signs were unrecognized due to the subtle nature of worsening status, or (3) when patients eliminated or minimized activities that prompted danger signs, they interpreted the results as improvement in status. Lack of recognition of HF danger signs and lack of understanding of how to control and minimize danger signs could lead to their escalation and prompt all-cause and HF-related health care resource utilization (HCRU). Investigators hypothesize that patients must understand HF danger signs to have self-confidence in recognizing them and in taking steps to minimize or eliminate their occurrence post hospital discharge. The purposes of this trial are to determine if video education in HF danger signs recognition and control prior to discharge (and post-discharge) reduces all-cause and HF-related health care resource utilization. The intervention will be administered during hospitalization, and patients and family members will receive a link to a website and a DVD to review videos as often as desired post-discharge. The primary end-point is 30-day HF-related hospitalization. 732 patients (658 + 10% attrition) with decompensated HF will be enrolled from multiple hospitals.
Interventions
BEHAVIORALDanger Signs of Heart Failure Videos
Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities) that reflect patient behaviors
Sponsors
Wellflix, Inc.
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Documentation of enrollment will not include group assignment Investigator will be blinded from group assignment via a separate excel file with that detail
Intervention model description
Randomized, controlled prospective trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Not referred for cardiac transplantation or ventricular assist device placement during the index hospitalization, * Cognitively intact and able to view videos (adequate eyesight and hearing) with correction, if needed, * Discharge to home, assisted living facility or to a family member's home and can control dietary sodium and fluids as needed, * Willing to participate; which may require up to three (3) follow-up telephone calls post-discharge.
Exclusion criteria
* Chart documented psychiatric or cognitive conditions that limit ability to understand video content or adhere to self-care recommendations (Alzheimer's condition, dementia, schizophrenia, other neurological history that impairs memory or concentration), * Plans to discharge to skilled nursing facility or hospice care, * 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 HF), * Hospitalized but at admission, in New York Heart Association functional class I or II HF * Post-cardiac transplantation or ventricular assist device placement, * Currently enrolled in another experimental HF research study, * Chronic renal failure and receiving chronic hemodialysis therapy for an estimated glomerular filtration rate \< 15 mL/minute/1.73 m2, * A non-traditional form of HF (hypertrophic or restrictive forms of cardiomyopathy, congenital heart disease or Takotsubo cardiomyopathy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HF-related Healthcare Resource Utilization (HCRU) | up to 30 days | Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HF-related ED Visits | up to 30 days | Number of participants with post-discharge HF-related ED visits |
| Number of Participants With HF-related Death | up to 30 days | Number of participants post-discharge with HF-related death |
| Number of Participants With HF-related Healthcare Resource Utilization (HCRU) | up to 90 days | Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge. |
| Number of Participants With HF-related ED Visit | up to 90 days | Number of participants post-discharge with HF-related ED visit |
| Number of Participants With All-cause Healthcare Resource Utilization (HCRU) | up to 30 days | Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge. |
| Number of Participants With All-cause Hospitalization | up to 30 days | Number of participants post-discharge with all-cause hospitalization |
| Number of Participants With All-cause ED Visits | 30 days | Number of participants with post-discharge all-cause ED visits |
| Number of Participants With All-cause Death | up to 30 days | Number of participants post-discharge with all-cause deaths |
| Number of Participants With HF-related Hospitalization | up to 30 days | Total number of participants post-discharge with HF-related hospitalization |
| All-cause Death at 180 Days Post Discharge | up to 180 days | Number of participants post-discharge with all-cause death |
| Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge | up to 30 days | Duke Activity Status Index (DASI) score at 30 days. Patients completed the DASI, a 12-item questionnaire using a Likert-like scale that determines a patient's ability to participate in daily self-care activities including ambulation, housework, yard work, sexual relations, and recreational activities. A total score reflects functional status based on responses. The full range of scores is 0 (most severe functional impairment) to 58.2 (no functional impairment). There is no established cut-point for this scale. Positive, higher scores reflect a positive and better functional status. |
| Dyspnea at 30 Days Post Discharge | 30 days | PROMIS® Dyspnea Functional Limitations - Short Form 10a was used. It is a 10-item tool that measures dyspnea by asking 10 questions about the difficulty in completing activities in the past 7 days. Responses range from 0 = no difficulty to 3 = much difficulty and there is an option for I did not do this in the past 7 days - there were 5 response options in total. Minimum and maximum raw scores are 0-30. PROMIS T scores are standardized with scores around 50 (standard deviation of 10) equating to normal/average levels and scores above or below equating to heightening or lessening of the variable being measured. A 5 point change in score is considered significant. A table is used to translate the total raw score to T score for each participant. |
| Fatigue at 30 Days Post Discharge | to 30 days | 10-item Fatigue Assessment Scale from baseline. The Fatigue Assessment Scale is a valid, reliable 10-item scale evaluating symptoms of chronic fatigue. It uses Likert-type response options ranging from 1 (never) to 5 (always), with some items reverse scored. Total scores range from 10 (lowest level of fatigue) to 50 (highest level of fatigue). |
| Self-efficacy for Managing Symptoms at 30 Days Post Discharge | 30 days | PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline. 8-item tool that ranges from 'I am not at all confident' to 'I am very confident - higher scores equals higher self-efficacy. A mean score of 50 is the average score in the general population of U.S. with standard deviation of 10. A table is used to translate the total raw score to T score for each participant. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores (above 50) reflect better than average self-efficacy |
| Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+) | 30 days | Among intervention group participants, total number of all-cause events within 30 days of discharge, based on the number of times the patient watched the video education. Participant responses are grouped into two categories: Never watched vs. 1 or more times |
| Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no) | 30 days | Total number of participants (video education group only), comparison of all-cause events within 30 days of discharge, based on family members watching the educational videos after the hospital (Yes/No). |
| All-cause ED Visits at 180 Days | up to 180 days | Number of participants post-discharge with all-cause ED visits |
Countries
United States
Participant flow
Recruitment details
Adult patients with decompensated HF, with preserved or reduced ejection fraction when hospitalized and New York Heart Association FC III or ambulatory IV symptoms, were recruited for this study between July 2018 to November 2020.
Pre-assignment details
In total, 746 patients started/completed study (377 patients randomized to usual care and 369 intervention).
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Group Usual care consists of patient's receiving a Heart Failure Handbook before hospital discharge + verbal education delivered by multiple care providers (including a group education class at 1 site). The handbook is consistent; however, verbal education may vary between care providers based on their knowledge and time available, and perceived patient needs | 377 |
| Video Education Group Will receive usual care, plus will watch 2 short Wellflix, Inc. Danger Signs of Heart Failure videos (via iPAD) on dyspnea, fatigue + a Danger Sign edema video, when applicable. Each video describes how to recognize if the sign/symptom is new or worsening and how to self-manage at home (via diet, fluid management and activity instructions)
Danger Signs of Heart Failure Videos: Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities) | 369 |
| Total | 746 |
Baseline characteristics
| Characteristic | Usual Care Group | Video Education Group | Total |
|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 12.5 | 67.7 years STANDARD_DEVIATION 12.3 | 68.0 years STANDARD_DEVIATION 12.4 |
| BMI | 32.2 Kg/m2 | 31.5 Kg/m2 | 31.9 Kg/m2 |
| Consider how well you live on income Comfortable, have more than enough to make ends meet | 99 Participants | 125 Participants | 224 Participants |
| Consider how well you live on income Do not have enough to make ends meet | 96 Participants | 107 Participants | 203 Participants |
| Consider how well you live on income Have enough to make ends meet | 179 Participants | 137 Participants | 316 Participants |
| Consider how well you live on income Missing survey response | 3 Participants | 0 Participants | 3 Participants |
| Employment status Employed full or part-time outside home | 40 Participants | 53 Participants | 93 Participants |
| Employment status Other | 11 Participants | 9 Participants | 20 Participants |
| Employment status Retired, not due to HF | 225 Participants | 202 Participants | 427 Participants |
| Employment status Sick leave or disability or retired due to HF | 84 Participants | 91 Participants | 175 Participants |
| Employment status Unemployed by choice or homemaker | 17 Participants | 14 Participants | 31 Participants |
| Highest level of education completed Bachelor/Associate/Professional degree | 57 Participants | 62 Participants | 119 Participants |
| Highest level of education completed High school or less | 205 Participants | 204 Participants | 409 Participants |
| Highest level of education completed Master/Doctoral degree | 28 Participants | 30 Participants | 58 Participants |
| Highest level of education completed Missing survey response | 1 Participants | 1 Participants | 2 Participants |
| Highest level of education completed Some college | 86 Participants | 72 Participants | 158 Participants |
| How far away in miles is your home to the hospital 15 miles or over 20 minutes | 100 Participants | 114 Participants | 214 Participants |
| How far away in miles is your home to the hospital Do not know the distance | 2 Participants | 1 Participants | 3 Participants |
| How far away in miles is your home to the hospital I have not seen a HF medical provider in >1 year | 3 Participants | 2 Participants | 5 Participants |
| How far away in miles is your home to the hospital Over 5 miles but under 15 miles | 147 Participants | 140 Participants | 287 Participants |
| How far away in miles is your home to the hospital Under 5 miles | 125 Participants | 112 Participants | 237 Participants |
| How far away in miles is your home to the office/clinic? 15 miles or over 20 minutes | 144 Participants | 157 Participants | 301 Participants |
| How far away in miles is your home to the office/clinic? Do not know the distance | 1 Participants | 1 Participants | 2 Participants |
| How far away in miles is your home to the office/clinic? I have not seen a HF medical provider in >1 year | 22 Participants | 17 Participants | 39 Participants |
| How far away in miles is your home to the office/clinic? Missing survey response | 0 Participants | 1 Participants | 1 Participants |
| How far away in miles is your home to the office/clinic? Over 5 miles but under 15 miles | 114 Participants | 127 Participants | 241 Participants |
| How far away in miles is your home to the office/clinic? Under 5 miles | 96 Participants | 66 Participants | 162 Participants |
| In general would you say your health is Excellent | 1 Participants | 1 Participants | 2 Participants |
| In general would you say your health is Fair | 158 Participants | 154 Participants | 312 Participants |
| In general would you say your health is Good | 109 Participants | 93 Participants | 202 Participants |
| In general would you say your health is Missing survey response | 1 Participants | 0 Participants | 1 Participants |
| In general would you say your health is Poor | 90 Participants | 105 Participants | 195 Participants |
| In general would you say your health is Very good | 18 Participants | 16 Participants | 34 Participants |
| Insurance Commercial | 39 Participants | 30 Participants | 69 Participants |
| Insurance Government | 197 Participants | 196 Participants | 393 Participants |
| Insurance Government and commercial | 40 Participants | 42 Participants | 82 Participants |
| Insurance Government and HMO | 55 Participants | 54 Participants | 109 Participants |
| Insurance HMO | 38 Participants | 38 Participants | 76 Participants |
| Insurance None | 8 Participants | 9 Participants | 17 Participants |
| Marital status Divorced/separated/widowed | 112 Participants | 98 Participants | 210 Participants |
| Marital status Living with child or another person not a spouse or partner | 19 Participants | 35 Participants | 54 Participants |
| Marital status Married, living with partner | 177 Participants | 170 Participants | 347 Participants |
| Marital status Single | 69 Participants | 66 Participants | 135 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 116 Participants | 118 Participants | 234 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 | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) White | 253 Participants | 243 Participants | 496 Participants |
| Region of Enrollment United States | 377 participants | 369 participants | 746 participants |
| Sex: Female, Male Female | 150 Participants | 179 Participants | 329 Participants |
| Sex: Female, Male Male | 227 Participants | 190 Participants | 417 Participants |
| Someone to confide in No | 15 Participants | 11 Participants | 26 Participants |
| Someone to confide in Yes | 362 Participants | 358 Participants | 720 Participants |
| Someone who supports you Missing survey response | 1 Participants | 0 Participants | 1 Participants |
| Someone who supports you No, no supporter available | 18 Participants | 14 Participants | 32 Participants |
| Someone who supports you No, not needed | 18 Participants | 16 Participants | 34 Participants |
| Someone who supports you Yes, have a support person | 340 Participants | 339 Participants | 679 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 42 / 377 | 40 / 369 |
| other Total, other adverse events | 0 / 377 | 0 / 369 |
| serious Total, serious adverse events | 232 / 377 | 242 / 369 |
Outcome results
Primary
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related Healthcare Resource Utilization (HCRU) | 64 Participants |
| Video Education Group | Number of Participants With HF-related Healthcare Resource Utilization (HCRU) | 59 Participants |
Secondary
All-cause Death at 180 Days Post Discharge
Number of participants post-discharge with all-cause death
Time frame: up to 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | All-cause Death at 180 Days Post Discharge | 42 Participants |
| Video Education Group | All-cause Death at 180 Days Post Discharge | 40 Participants |
p-value: 0.9Chi-squared
Secondary
All-cause ED Visits at 180 Days
Number of participants post-discharge with all-cause ED visits
Time frame: up to 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | All-cause ED Visits at 180 Days | 160 Participants |
| Video Education Group | All-cause ED Visits at 180 Days | 179 Participants |
p-value: 0.0096Chi-squared
Secondary
Dyspnea at 30 Days Post Discharge
PROMIS® Dyspnea Functional Limitations - Short Form 10a was used. It is a 10-item tool that measures dyspnea by asking 10 questions about the difficulty in completing activities in the past 7 days. Responses range from 0 = no difficulty to 3 = much difficulty and there is an option for I did not do this in the past 7 days - there were 5 response options in total. Minimum and maximum raw scores are 0-30. PROMIS T scores are standardized with scores around 50 (standard deviation of 10) equating to normal/average levels and scores above or below equating to heightening or lessening of the variable being measured. A 5 point change in score is considered significant. A table is used to translate the total raw score to T score for each participant.
Time frame: 30 days
Population: The number analyzed in both groups was lower than the number enrolled. This is due to the research team being unable to contact some patients by phone for study follow-up or the patient was deceased (medical record chart review).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Dyspnea at 30 Days Post Discharge | 46.1 score on a scale | Standard Deviation 8.5 |
| Video Education Group | Dyspnea at 30 Days Post Discharge | 45.8 score on a scale | Standard Deviation 8.5 |
Secondary
Fatigue at 30 Days Post Discharge
10-item Fatigue Assessment Scale from baseline. The Fatigue Assessment Scale is a valid, reliable 10-item scale evaluating symptoms of chronic fatigue. It uses Likert-type response options ranging from 1 (never) to 5 (always), with some items reverse scored. Total scores range from 10 (lowest level of fatigue) to 50 (highest level of fatigue).
Time frame: to 30 days
Population: The number analyzed in both groups was lower than the number enrolled. This is due to the research team being unable to contact some patients by phone for study follow-up or the patient was deceased (medical record chart review).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Fatigue at 30 Days Post Discharge | 23.8 score on a scale | Standard Deviation 8.5 |
| Video Education Group | Fatigue at 30 Days Post Discharge | 23.3 score on a scale | Standard Deviation 8.4 |
Secondary
Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge
Duke Activity Status Index (DASI) score at 30 days. Patients completed the DASI, a 12-item questionnaire using a Likert-like scale that determines a patient's ability to participate in daily self-care activities including ambulation, housework, yard work, sexual relations, and recreational activities. A total score reflects functional status based on responses. The full range of scores is 0 (most severe functional impairment) to 58.2 (no functional impairment). There is no established cut-point for this scale. Positive, higher scores reflect a positive and better functional status.
Time frame: up to 30 days
Population: The number analyzed in both groups was lower than the number enrolled. This is due to the research team being unable to contact some patients by phone for study follow-up or the patient was deceased (medical record chart review).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge | 17.2 score on a scale | Standard Deviation 11.2 |
| Video Education Group | Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge | 18.2 score on a scale | Standard Deviation 11.6 |
Secondary
Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)
Among intervention group participants, total number of all-cause events within 30 days of discharge, based on the number of times the patient watched the video education. Participant responses are grouped into two categories: Never watched vs. 1 or more times
Time frame: 30 days
Population: The number analyzed (n=304) was lower than the number enrolled due to inability to contact some patients by phone for study follow-up or the patient was deceased (as a note, this info was not available in the medical record).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+) | 76 Participants |
| Video Education Group | Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+) | 25 Participants |
Secondary
Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no)
Total number of participants (video education group only), comparison of all-cause events within 30 days of discharge, based on family members watching the educational videos after the hospital (Yes/No).
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no) | 94 Participants |
| Video Education Group | Intervention Group Only; Number of All-cause Events Based on Dichotomous Outcome of Family Member Viewing Educational Video After Hospital Discharge (Yes vs no) | 7 Participants |
Secondary
Number of Participants With All-cause Death
Number of participants post-discharge with all-cause deaths
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause Death | 13 Participants |
| Video Education Group | Number of Participants With All-cause Death | 11 Participants |
Secondary
Number of Participants With All-cause Death
Number of participants post-discharge with all-cause death
Time frame: up to 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause Death | 30 Participants |
| Video Education Group | Number of Participants With All-cause Death | 22 Participants |
Secondary
Number of Participants With All-cause ED Visits
Number of participants post-discharge with all-cause ED visits
Time frame: up to 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause ED Visits | 132 Participants |
| Video Education Group | Number of Participants With All-cause ED Visits | 134 Participants |
Secondary
Number of Participants With All-cause ED Visits
Number of participants with post-discharge all-cause ED visits
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause ED Visits | 79 Participants |
| Video Education Group | Number of Participants With All-cause ED Visits | 84 Participants |
Secondary
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 30 days of discharge.
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause Healthcare Resource Utilization (HCRU) | 124 Participants |
| Video Education Group | Number of Participants With All-cause Healthcare Resource Utilization (HCRU) | 130 Participants |
Secondary
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.
Time frame: up to 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause Healthcare Resource Utilization (HCRU) | 194 Participants |
| Video Education Group | Number of Participants With All-cause Healthcare Resource Utilization (HCRU) | 194 Participants |
Secondary
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with all-cause healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.
Time frame: up to 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause Healthcare Resource Utilization (HCRU) | 232 Participants |
| Video Education Group | Number of Participants With All-cause Healthcare Resource Utilization (HCRU) | 242 Participants |
Secondary
Number of Participants With All-cause Hospitalization
Number of participants post-discharge with all-cause hospitalization
Time frame: up to 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause Hospitalization | 195 Participants |
| Video Education Group | Number of Participants With All-cause Hospitalization | 188 Participants |
Secondary
Number of Participants With All-cause Hospitalization
Number of participants post-discharge with all-cause hospitalization
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause Hospitalization | 75 Participants |
| Video Education Group | Number of Participants With All-cause Hospitalization | 78 Participants |
Secondary
Number of Participants With All-cause Hospitalization
Number of participants with post-discharge all-cause hospitalization
Time frame: up to 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With All-cause Hospitalization | 148 Participants |
| Video Education Group | Number of Participants With All-cause Hospitalization | 134 Participants |
Secondary
Number of Participants With HF-related Death
Number of participants post-discharge with HF-related death
Time frame: up to 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related Death | 12 Participants |
| Video Education Group | Number of Participants With HF-related Death | 11 Participants |
Secondary
Number of Participants With HF-related Death
Number of participants post-discharge with HF-related death
Time frame: up to 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related Death | 15 Participants |
| Video Education Group | Number of Participants With HF-related Death | 14 Participants |
Secondary
Number of Participants With HF-related Death
Number of participants post-discharge with HF-related death
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related Death | 5 Participants |
| Video Education Group | Number of Participants With HF-related Death | 4 Participants |
Secondary
Number of Participants With HF-related ED Visit
Number of participants post-discharge with HF-related ED visit
Time frame: up to 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related ED Visit | 73 Participants |
| Video Education Group | Number of Participants With HF-related ED Visit | 91 Participants |
Secondary
Number of Participants With HF-related ED Visit
Number of participants post-discharge with HF-related ED visit
Time frame: up to 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related ED Visit | 63 Participants |
| Video Education Group | Number of Participants With HF-related ED Visit | 70 Participants |
Secondary
Number of Participants With HF-related ED Visits
Number of participants with post-discharge HF-related ED visits
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related ED Visits | 40 Participants |
| Video Education Group | Number of Participants With HF-related ED Visits | 36 Participants |
Secondary
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 90 days of discharge.
Time frame: up to 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related Healthcare Resource Utilization (HCRU) | 93 Participants |
| Video Education Group | Number of Participants With HF-related Healthcare Resource Utilization (HCRU) | 102 Participants |
Secondary
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
Number of participants post-discharge with HF-related healthcare resource utilization including hospitalization, emergency department (ED) visits, death, or cardiac transplant within 180 days of discharge.
Time frame: up to 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related Healthcare Resource Utilization (HCRU) | 111 Participants |
| Video Education Group | Number of Participants With HF-related Healthcare Resource Utilization (HCRU) | 135 Participants |
Secondary
Number of Participants With HF-related Hospitalization
Total number of participants post-discharge with HF-related hospitalization
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related Hospitalization | 52 Participants |
| Video Education Group | Number of Participants With HF-related Hospitalization | 51 Participants |
Secondary
Number of Participants With HF-related Hospitalization
Number of participants post-discharge with HF-related hospitalization
Time frame: up to 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related Hospitalization | 87 Participants |
| Video Education Group | Number of Participants With HF-related Hospitalization | 95 Participants |
Secondary
Number of Participants With HF-related Hospitalization
Number of participants post-discharge with HF-related hospitalization
Time frame: up to 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Number of Participants With HF-related Hospitalization | 104 Participants |
| Video Education Group | Number of Participants With HF-related Hospitalization | 128 Participants |
Secondary
Self-efficacy for Managing Symptoms at 30 Days Post Discharge
PROMIS Self-Efficacy for Managing Symptoms Short form 8a for managing symptoms, from baseline. 8-item tool that ranges from 'I am not at all confident' to 'I am very confident - higher scores equals higher self-efficacy. A mean score of 50 is the average score in the general population of U.S. with standard deviation of 10. A table is used to translate the total raw score to T score for each participant. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores (above 50) reflect better than average self-efficacy
Time frame: 30 days
Population: The number analyzed in both groups was lower than the number enrolled. This is due to the research team being unable to contact some patients by phone for study follow-up or the patient was deceased (medical record).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Self-efficacy for Managing Symptoms at 30 Days Post Discharge | 42.9 score on a scale | Standard Deviation 8.4 |
| Video Education Group | Self-efficacy for Managing Symptoms at 30 Days Post Discharge | 43.4 score on a scale | Standard Deviation 7.8 |