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| Name | Class |
|---|---|
| Wellflix, Inc. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual care group | No Intervention | 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 | |
| video education group | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danger Signs of Heart Failure Videos | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HF-related Hospitalization | Total number of participants post-discharge with HF-related hospitalization | up to 30 days |
| Number of Participants With HF-related ED Visits |
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Inclusion Criteria:
Exclusion Criteria:
Please answer each question as it applies to you.
Sex: 0.______ Male 1.______ Female
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| Name | Affiliation | Role |
|---|---|---|
| NANCY M. ALBERT, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Center Navicent Health | Macon | Georgia | 31201 | United States | ||
| Cleveland Clinic Fairview Hospital |
No plans to share individual data
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In total, 746 patients started/completed study (377 patients randomized to usual care and 369 intervention).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 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. | Posted | Count of Participants | Participants | up to 30 days |
|
Adverse events recorded for this study were NON-treatment-related. Patient charts were monitored at 180 days (6 months) and considered to be non-direct patient outcomes becasue of the nature of participants medical condition, in general.
Adverse events were NON-treatment-related as the intervention was video education. The IRB approved this study as minimal risk and adverse events were NOT collected or recorded except those believed to be important indirect (no direct) heart failure and all-cause 180 day outcomes (death, emaergency department visits and hospitalizations). Patient charts were monitored for the above outcomes at180 days (6 months).
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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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-cause 180 day emergency department, hospitalization, transplant/left ventricular assist device o | Cardiac disorders | Systematic Assessment | Events were considered non-direct in relation to the education video as education is an INDIRECT effect of all-cuase related outcomes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy M. Albert PhD, CCNS, CHFN, 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 | Nov 7, 2018 | Mar 29, 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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Randomized, controlled prospective trial
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Documentation of enrollment will not include group assignment Investigator will be blinded from group assignment via a separate excel file with that detail
Number of participants with post-discharge HF-related ED visits
| up to 30 days |
| Number of Participants With HF-related Death | Number of participants post-discharge with HF-related death | up to 30 days |
| 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. | up to 90 days |
| Number of Participants With HF-related Hospitalization | Number of participants post-discharge with HF-related hospitalization | up to 90 days |
| Number of Participants With HF-related ED Visit | Number of participants post-discharge with HF-related ED visit | up to 90 days |
| Number of Participants With HF-related Death | Number of participants post-discharge with HF-related death | up to 90 days |
| 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. | up to 180 days |
| Number of Participants With HF-related Hospitalization | Number of participants post-discharge with HF-related hospitalization | up to 180 days |
| Number of Participants With HF-related ED Visit | Number of participants post-discharge with HF-related ED visit | up to 180 days |
| Number of Participants With HF-related Death | Number of participants post-discharge with HF-related death | up to 180 days |
| 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. | up to 30 days |
| Number of Participants With All-cause Hospitalization | Number of participants post-discharge with all-cause hospitalization | up to 30 days |
| Number of Participants With All-cause ED Visits | Number of participants with post-discharge all-cause ED visits | 30 days |
| Number of Participants With All-cause Death | Number of participants post-discharge with all-cause deaths | up to 30 days |
| 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. | up to 90 days |
| Number of Participants With All-cause Hospitalization | Number of participants with post-discharge all-cause hospitalization | up to 90 days |
| Number of Participants With All-cause ED Visits | Number of participants post-discharge with all-cause ED visits | up to 90 days |
| Number of Participants With All-cause Death | Number of participants post-discharge with all-cause death | up to 90 days |
| 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. | up to 180 days |
| Number of Participants With All-cause Hospitalization | Number of participants post-discharge with all-cause hospitalization | up to 180 days |
| All-cause ED Visits at 180 Days | Number of participants post-discharge with all-cause ED visits | up to 180 days |
| All-cause Death at 180 Days Post Discharge | Number of participants post-discharge with all-cause death | up to 180 days |
| 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. | up to 30 days |
| 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. | 30 days |
| 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). | to 30 days |
| 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 | 30 days |
| 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 | 30 days |
| 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). | 30 days |
| Cleveland |
| Ohio |
| 44111 |
| United States |
| Cleveland Clinic main campus | Cleveland | Ohio | 44195 | United States |
| Cleveland Clinic Marymount Hospital | Garfield Heights | Ohio | 44125 | United States |
| Cleveland Clinic Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | United States |
| Cleveland Clinic Medina Hospital | Medina | Ohio | 44256 | United States |
| Cleveland Clinic South Pointe Hospital | Warrensville Heights | Ohio | 44122 | United States |
| WellSpan Health | York | Pennsylvania | 15198 | United States |
| BG001 | 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) |
| 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 |
|
| Someone who supports you | Count of Participants | Participants |
|
| 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 |
|
| BMI | measures the ratio of height to weight to estimate the amount of body fat a person has. BMI is calculated by using weight in kilograms (kg) divided by the square of height in meters (m2) [kg/m2]. | Median | Inter-Quartile Range | Kg/m2 |
|
| Insurance | Count of Participants | Participants |
|
| How far away in miles is your home to the office/clinic? | Count of Participants | Participants |
|
| How far away in miles is your home to the hospital | Count of Participants | Participants |
|
| In general would you say your health is | Count of Participants | Participants |
|
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) |
|
|
| Secondary | Number of Participants With HF-related Hospitalization | Total number of participants post-discharge with HF-related hospitalization | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| Secondary | Number of Participants With HF-related ED Visits | Number of participants with post-discharge HF-related ED visits | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| Secondary | Number of Participants With HF-related Death | Number of participants post-discharge with HF-related death | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| 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. | Posted | Count of Participants | Participants | up to 90 days |
|
|
|
| Secondary | Number of Participants With HF-related Hospitalization | Number of participants post-discharge with HF-related hospitalization | Posted | Count of Participants | Participants | up to 90 days |
|
|
|
| Secondary | Number of Participants With HF-related ED Visit | Number of participants post-discharge with HF-related ED visit | Posted | Count of Participants | Participants | up to 90 days |
|
|
|
| Secondary | Number of Participants With HF-related Death | Number of participants post-discharge with HF-related death | Posted | Count of Participants | Participants | up to 90 days |
|
|
|
| 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. | Posted | Count of Participants | Participants | up to 180 days |
|
|
|
| Secondary | Number of Participants With HF-related Hospitalization | Number of participants post-discharge with HF-related hospitalization | Posted | Count of Participants | Participants | up to 180 days |
|
|
|
| Secondary | Number of Participants With HF-related ED Visit | Number of participants post-discharge with HF-related ED visit | Posted | Count of Participants | Participants | up to 180 days |
|
|
|
| Secondary | Number of Participants With HF-related Death | Number of participants post-discharge with HF-related death | Posted | Count of Participants | Participants | up to 180 days |
|
|
|
| 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. | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| Secondary | Number of Participants With All-cause Hospitalization | Number of participants post-discharge with all-cause hospitalization | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| Secondary | Number of Participants With All-cause ED Visits | Number of participants with post-discharge all-cause ED visits | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Number of Participants With All-cause Death | Number of participants post-discharge with all-cause deaths | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| 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. | Posted | Count of Participants | Participants | up to 90 days |
|
|
|
| Secondary | Number of Participants With All-cause Hospitalization | Number of participants with post-discharge all-cause hospitalization | Posted | Count of Participants | Participants | up to 90 days |
|
|
|
| Secondary | Number of Participants With All-cause ED Visits | Number of participants post-discharge with all-cause ED visits | Posted | Count of Participants | Participants | up to 90 days |
|
|
|
| Secondary | Number of Participants With All-cause Death | Number of participants post-discharge with all-cause death | Posted | Count of Participants | Participants | up to 90 days |
|
|
|
| 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. | Posted | Count of Participants | Participants | up to 180 days |
|
|
|
| Secondary | Number of Participants With All-cause Hospitalization | Number of participants post-discharge with all-cause hospitalization | Posted | Count of Participants | Participants | up to 180 days |
|
|
|
| Secondary | All-cause ED Visits at 180 Days | Number of participants post-discharge with all-cause ED visits | Posted | Count of Participants | Participants | up to 180 days |
|
|
|
|
| Secondary | All-cause Death at 180 Days Post Discharge | Number of participants post-discharge with all-cause death | Posted | Count of Participants | Participants | up to 180 days |
|
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | up to 30 days |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
|
|
| 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). | 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). | Posted | Mean | Standard Deviation | score on a scale | to 30 days |
|
|
|
| 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 | 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). | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
|
|
| 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 | 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). | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 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). | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 42 |
| 377 |
| 232 |
| 377 |
| 0 |
| 377 |
| EG001 | Video Education Group | Will receive usual care, plus will watch short videos from Wellflix, Inc.: 1) "Danger Signs of Heart Failure" videos (via iPAD) on dyspnea and fatigue; and 2) "Danger Signs edema" video. Each video describes how to recognize if the patient's signs/symptoms are new or worsening and how to self-manage at home via diet, fluid management, and physical activity instructions. Danger Signs of Heart Failure Videos are short videos (less than 3 minutes each). The videos contain educational information on (a) recognition of dyspnea, fatigue, and edema; and (b) self-management (based on diet, fluid management, and activities) | 40 | 369 | 242 | 369 | 0 | 369 |
|
Not provided
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