Trial Outcomes & Findings for Danger Signs in Heart Failure- Effects of Video Education (NCT NCT03657459)
NCT ID: NCT03657459
Last Updated: 2025-05-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
746 participants
Primary outcome timeframe
up to 30 days
Results posted on
2025-05-07
Participant Flow
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.
In total, 746 patients started/completed study (377 patients randomized to usual care and 369 intervention).
Participant milestones
| Measure |
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
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
377
|
369
|
|
Overall Study
COMPLETED
|
377
|
369
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Danger Signs in Heart Failure- Effects of Video Education
Baseline characteristics by cohort
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
Total
n=746 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
67.7 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
68.0 years
STANDARD_DEVIATION 12.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=93 Participants
|
179 Participants
n=4 Participants
|
329 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
227 Participants
n=93 Participants
|
190 Participants
n=4 Participants
|
417 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
116 Participants
n=93 Participants
|
118 Participants
n=4 Participants
|
234 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
253 Participants
n=93 Participants
|
243 Participants
n=4 Participants
|
496 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
377 participants
n=93 Participants
|
369 participants
n=4 Participants
|
746 participants
n=27 Participants
|
|
Marital status
Single
|
69 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
|
Marital status
Married, living with partner
|
177 Participants
n=93 Participants
|
170 Participants
n=4 Participants
|
347 Participants
n=27 Participants
|
|
Marital status
Divorced/separated/widowed
|
112 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
210 Participants
n=27 Participants
|
|
Marital status
Living with child or another person not a spouse or partner
|
19 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Someone who supports you
No, not needed
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Someone who supports you
No, no supporter available
|
18 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Someone who supports you
Yes, have a support person
|
340 Participants
n=93 Participants
|
339 Participants
n=4 Participants
|
679 Participants
n=27 Participants
|
|
Someone who supports you
Missing survey response
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Someone to confide in
No
|
15 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Someone to confide in
Yes
|
362 Participants
n=93 Participants
|
358 Participants
n=4 Participants
|
720 Participants
n=27 Participants
|
|
Highest level of education completed
High school or less
|
205 Participants
n=93 Participants
|
204 Participants
n=4 Participants
|
409 Participants
n=27 Participants
|
|
Highest level of education completed
Some college
|
86 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
158 Participants
n=27 Participants
|
|
Highest level of education completed
Bachelor/Associate/Professional degree
|
57 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
119 Participants
n=27 Participants
|
|
Highest level of education completed
Master/Doctoral degree
|
28 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Highest level of education completed
Missing survey response
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Employment status
Employed full or part-time outside home
|
40 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
93 Participants
n=27 Participants
|
|
Employment status
Unemployed by choice or homemaker
|
17 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Employment status
Sick leave or disability or retired due to HF
|
84 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
175 Participants
n=27 Participants
|
|
Employment status
Retired, not due to HF
|
225 Participants
n=93 Participants
|
202 Participants
n=4 Participants
|
427 Participants
n=27 Participants
|
|
Employment status
Other
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Consider how well you live on income
Comfortable, have more than enough to make ends meet
|
99 Participants
n=93 Participants
|
125 Participants
n=4 Participants
|
224 Participants
n=27 Participants
|
|
Consider how well you live on income
Have enough to make ends meet
|
179 Participants
n=93 Participants
|
137 Participants
n=4 Participants
|
316 Participants
n=27 Participants
|
|
Consider how well you live on income
Do not have enough to make ends meet
|
96 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
203 Participants
n=27 Participants
|
|
Consider how well you live on income
Missing survey response
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
BMI
|
32.2 Kg/m2
n=93 Participants
|
31.5 Kg/m2
n=4 Participants
|
31.9 Kg/m2
n=27 Participants
|
|
Insurance
Government
|
197 Participants
n=93 Participants
|
196 Participants
n=4 Participants
|
393 Participants
n=27 Participants
|
|
Insurance
Commercial
|
39 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Insurance
HMO
|
38 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Insurance
None
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Insurance
Government and commercial
|
40 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Insurance
Government and HMO
|
55 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
|
How far away in miles is your home to the office/clinic?
Under 5 miles
|
96 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
162 Participants
n=27 Participants
|
|
How far away in miles is your home to the office/clinic?
Over 5 miles but under 15 miles
|
114 Participants
n=93 Participants
|
127 Participants
n=4 Participants
|
241 Participants
n=27 Participants
|
|
How far away in miles is your home to the office/clinic?
15 miles or over 20 minutes
|
144 Participants
n=93 Participants
|
157 Participants
n=4 Participants
|
301 Participants
n=27 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
n=93 Participants
|
17 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
How far away in miles is your home to the office/clinic?
Do not know the distance
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
How far away in miles is your home to the office/clinic?
Missing survey response
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
How far away in miles is your home to the hospital
Under 5 miles
|
125 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
237 Participants
n=27 Participants
|
|
How far away in miles is your home to the hospital
Over 5 miles but under 15 miles
|
147 Participants
n=93 Participants
|
140 Participants
n=4 Participants
|
287 Participants
n=27 Participants
|
|
How far away in miles is your home to the hospital
15 miles or over 20 minutes
|
100 Participants
n=93 Participants
|
114 Participants
n=4 Participants
|
214 Participants
n=27 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
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
How far away in miles is your home to the hospital
Do not know the distance
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
In general would you say your health is
Excellent
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
In general would you say your health is
Very good
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
In general would you say your health is
Good
|
109 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
202 Participants
n=27 Participants
|
|
In general would you say your health is
Fair
|
158 Participants
n=93 Participants
|
154 Participants
n=4 Participants
|
312 Participants
n=27 Participants
|
|
In general would you say your health is
Poor
|
90 Participants
n=93 Participants
|
105 Participants
n=4 Participants
|
195 Participants
n=27 Participants
|
|
In general would you say your health is
Missing survey response
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 30 daysNumber 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.
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
|
64 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysTotal number of participants post-discharge with HF-related hospitalization
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related Hospitalization
|
52 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysNumber of participants with post-discharge HF-related ED visits
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related ED Visits
|
40 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysNumber of participants post-discharge with HF-related death
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related Death
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysNumber 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.
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
|
93 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysNumber of participants post-discharge with HF-related hospitalization
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related Hospitalization
|
87 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysNumber of participants post-discharge with HF-related ED visit
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related ED Visit
|
63 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysNumber of participants post-discharge with HF-related death
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related Death
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: up to 180 daysNumber 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.
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related Healthcare Resource Utilization (HCRU)
|
111 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: up to 180 daysNumber of participants post-discharge with HF-related hospitalization
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related Hospitalization
|
104 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: up to 180 daysNumber of participants post-discharge with HF-related ED visit
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related ED Visit
|
73 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: up to 180 daysNumber of participants post-discharge with HF-related death
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With HF-related Death
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysNumber 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.
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
|
124 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysNumber of participants post-discharge with all-cause hospitalization
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause Hospitalization
|
75 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of participants with post-discharge all-cause ED visits
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause ED Visits
|
79 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysNumber of participants post-discharge with all-cause deaths
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause Death
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysNumber 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.
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
|
194 Participants
|
194 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysNumber of participants with post-discharge all-cause hospitalization
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause Hospitalization
|
148 Participants
|
134 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysNumber of participants post-discharge with all-cause ED visits
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause ED Visits
|
132 Participants
|
134 Participants
|
SECONDARY outcome
Timeframe: up to 90 daysNumber of participants post-discharge with all-cause death
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause Death
|
30 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: up to 180 daysNumber 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.
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause Healthcare Resource Utilization (HCRU)
|
232 Participants
|
242 Participants
|
SECONDARY outcome
Timeframe: up to 180 daysNumber of participants post-discharge with all-cause hospitalization
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
Number of Participants With All-cause Hospitalization
|
195 Participants
|
188 Participants
|
SECONDARY outcome
Timeframe: up to 180 daysNumber of participants post-discharge with all-cause ED visits
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
All-cause ED Visits at 180 Days
|
160 Participants
|
179 Participants
|
SECONDARY outcome
Timeframe: up to 180 daysNumber of participants post-discharge with all-cause death
Outcome measures
| Measure |
Usual Care Group
n=377 Participants
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
n=369 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)
|
|---|---|---|
|
All-cause Death at 180 Days Post Discharge
|
42 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: up to 30 daysPopulation: 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).
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.
Outcome measures
| Measure |
Usual Care Group
n=334 Participants
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
n=330 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)
|
|---|---|---|
|
Functional Status Using the Duke Acrivity Status Index Scale at 30 Days Post Discharge
|
17.2 score on a scale
Standard Deviation 11.2
|
18.2 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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).
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.
Outcome measures
| Measure |
Usual Care Group
n=321 Participants
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
n=319 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)
|
|---|---|---|
|
Dyspnea at 30 Days Post Discharge
|
46.1 score on a scale
Standard Deviation 8.5
|
45.8 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: to 30 daysPopulation: 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).
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).
Outcome measures
| Measure |
Usual Care Group
n=322 Participants
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
n=320 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)
|
|---|---|---|
|
Fatigue at 30 Days Post Discharge
|
23.8 score on a scale
Standard Deviation 8.5
|
23.3 score on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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).
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
Outcome measures
| Measure |
Usual Care Group
n=322 Participants
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
n=319 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)
|
|---|---|---|
|
Self-efficacy for Managing Symptoms at 30 Days Post Discharge
|
42.9 score on a scale
Standard Deviation 8.4
|
43.4 score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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).
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
Outcome measures
| Measure |
Usual Care Group
n=227 Participants
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
n=77 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)
|
|---|---|---|
|
Intervention Group Only- All-cause Events Based on Dichotomous Metric of Viewing the Video at Home (Never vs 1+)
|
76 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 30 daysTotal 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).
Outcome measures
| Measure |
Usual Care Group
n=272 Participants
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
n=32 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)
|
|---|---|---|
|
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
|
7 Participants
|
Adverse Events
Usual Care Group
Serious events: 232 serious events
Other events: 0 other events
Deaths: 42 deaths
Video Education Group
Serious events: 242 serious events
Other events: 0 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Usual Care Group
n=377 participants at risk
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
n=369 participants at risk
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)
|
|---|---|---|
|
Cardiac disorders
All-cause 180 day emergency department, hospitalization, transplant/left ventricular assist device o
|
61.5%
232/377 • 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).
|
65.6%
242/369 • 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).
|
Other adverse events
Adverse event data not reported
Additional Information
Nancy M. Albert PhD, CCNS, CHFN, CCRN, NE-BC, FAHA, FCCM, FHFSA, FAAN
Cleveland Clinic
Phone: 216-444-7028
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place