Trial Outcomes & Findings for My Recordable On-Demand Audio Discharge Instructions (NCT NCT02901314)
NCT ID: NCT02901314
Last Updated: 2025-05-07
Results Overview
Number of patients re-hospitalized with heart failure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2487 participants
Primary outcome timeframe
30 day
Results posted on
2025-05-07
Participant Flow
Adults with decompensated heart failure HF with preserved or reduced ejection fraction when hospitalized and New York Heart Association FC III or ambulatory IV. Dates of enrollment occurred between March 2016 to June 2019.
Of the 2487 patients enrolled, 1073 met inclusion criteria and were randomized to either usual care or usual care + intervention (My Recordable On-Demand Audio Discharge Instructions MyROAD card).
Participant milestones
| Measure |
MyRoad
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Overall Study
STARTED
|
538
|
535
|
|
Overall Study
COMPLETED
|
506
|
491
|
|
Overall Study
NOT COMPLETED
|
32
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
My Recordable On-Demand Audio Discharge Instructions
Baseline characteristics by cohort
| Measure |
MyRoad
n=506 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=491 Participants
Receives usual care heart failure education before discharge
|
Total
n=997 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 11.2 • n=93 Participants
|
73.1 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
72.8 years
STANDARD_DEVIATION 11.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=93 Participants
|
206 Participants
n=4 Participants
|
412 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
300 Participants
n=93 Participants
|
285 Participants
n=4 Participants
|
585 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 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
|
123 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
243 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
375 Participants
n=93 Participants
|
362 Participants
n=4 Participants
|
737 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
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
506 participants
n=93 Participants
|
491 participants
n=4 Participants
|
997 participants
n=27 Participants
|
|
Marital status
Single
|
66 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
141 Participants
n=27 Participants
|
|
Marital status
Married
|
255 Participants
n=93 Participants
|
239 Participants
n=4 Participants
|
494 Participants
n=27 Participants
|
|
Marital status
Divorced/Separated
|
66 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
133 Participants
n=27 Participants
|
|
Marital status
Widowed
|
108 Participants
n=93 Participants
|
104 Participants
n=4 Participants
|
212 Participants
n=27 Participants
|
|
Marital status
Co-habitate (living with partner)
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Location
Main campus
|
288 Participants
n=93 Participants
|
282 Participants
n=4 Participants
|
570 Participants
n=27 Participants
|
|
Location
Hillcrest
|
115 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
231 Participants
n=27 Participants
|
|
Location
Fairview
|
73 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Location
Medina
|
30 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Do you currently live with another person?
Yes
|
390 Participants
n=93 Participants
|
374 Participants
n=4 Participants
|
764 Participants
n=27 Participants
|
|
Do you currently live with another person?
No
|
116 Participants
n=93 Participants
|
117 Participants
n=4 Participants
|
233 Participants
n=27 Participants
|
|
Do you have someone to confide in?
Yes
|
492 Participants
n=93 Participants
|
482 Participants
n=4 Participants
|
974 Participants
n=27 Participants
|
|
Do you have someone to confide in?
No
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Do you have someone to confide in?
Missing survey response
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Highest level of education completed
Less than high school graduate
|
75 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
144 Participants
n=27 Participants
|
|
Highest level of education completed
General Educational Development (GED)
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Highest level of education completed
High school graduate
|
182 Participants
n=93 Participants
|
172 Participants
n=4 Participants
|
354 Participants
n=27 Participants
|
|
Highest level of education completed
Some college or professional training post high school
|
131 Participants
n=93 Participants
|
143 Participants
n=4 Participants
|
274 Participants
n=27 Participants
|
|
Highest level of education completed
Associate degree
|
17 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Highest level of education completed
Bachelor's degree
|
61 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Highest level of education completed
Master's degree
|
24 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Highest level of education completed
Doctoral degree
|
8 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Employment status
Employed full or part-time
|
60 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
121 Participants
n=27 Participants
|
|
Employment status
Unemployed by choice
|
22 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Employment status
Sick leave or disability
|
46 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Employment status
Retired due to HF
|
60 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
111 Participants
n=27 Participants
|
|
Employment status
Retired, not due to HF
|
318 Participants
n=93 Participants
|
310 Participants
n=4 Participants
|
628 Participants
n=27 Participants
|
|
Employment status
Other
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Consider how well you live on income
Comfortable, more than enough
|
158 Participants
n=93 Participants
|
137 Participants
n=4 Participants
|
295 Participants
n=27 Participants
|
|
Consider how well you live on income
Have enough to make ends meet
|
224 Participants
n=93 Participants
|
232 Participants
n=4 Participants
|
456 Participants
n=27 Participants
|
|
Consider how well you live on income
Do not have enough to make ends meet
|
124 Participants
n=93 Participants
|
122 Participants
n=4 Participants
|
246 Participants
n=27 Participants
|
|
In general, would you say your health is
Poor
|
135 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
254 Participants
n=27 Participants
|
|
In general, would you say your health is
Fair
|
200 Participants
n=93 Participants
|
222 Participants
n=4 Participants
|
422 Participants
n=27 Participants
|
|
In general, would you say your health is
Good
|
138 Participants
n=93 Participants
|
110 Participants
n=4 Participants
|
248 Participants
n=27 Participants
|
|
In general, would you say your health is
Very good
|
23 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
In general, would you say your health is
Excellent
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Health care services
When was the last time you were in hospital for any reason? · Left the hospital within the last 7 days
|
33 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
Health care services
When was the last time you were in hospital for any reason? · Left the hospital 2 weeks ago (8-14 days ago)
|
50 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
|
Health care services
When was the last time you were in hospital for any reason? · Left the hospital 3-4 weeks ago (15-30 days ago)
|
59 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
|
Health care services
When was the last time you were in hospital for any reason? · Left the hospital over 1 month ago but <3 months ago
|
125 Participants
n=93 Participants
|
126 Participants
n=4 Participants
|
251 Participants
n=27 Participants
|
|
Health care services
When was the last time you were in hospital for any reason? · Longer than 3 months ago
|
239 Participants
n=93 Participants
|
248 Participants
n=4 Participants
|
487 Participants
n=27 Participants
|
|
Health care services
When was the last time you were in hospital for any reason? · Don't remember or never been in hospital
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Health care services
When was the last time you were hospitalized for heart failure? · Left the hospital within the last 7 days
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Health care services
When was the last time you were hospitalized for heart failure? · Left the hospital 2 weeks ago (8-14 days ago)
|
36 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Health care services
When was the last time you were hospitalized for heart failure? · Left the hospital 3-4 weeks ago (15-30 days ago)
|
50 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Health care services
When was the last time you were hospitalized for heart failure? · Left the hospital over 1 month ago but <3 months ago
|
90 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
187 Participants
n=27 Participants
|
|
Health care services
When was the last time you were hospitalized for heart failure? · Longer than 3 months ago
|
300 Participants
n=93 Participants
|
292 Participants
n=4 Participants
|
592 Participants
n=27 Participants
|
|
Health care services
When was the last time you were hospitalized for heart failure? · Don't remember or never been in hospital
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Health care services
When was last time you were in hospital for your heart, but not heart failure · Left the hospital within the last 7 days
|
15 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Health care services
When was last time you were in hospital for your heart, but not heart failure · Left the hospital 2 weeks ago (8-14 days ago)
|
24 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Health care services
When was last time you were in hospital for your heart, but not heart failure · Left the hospital 3-4 weeks ago (15-30 days ago)
|
27 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Health care services
When was last time you were in hospital for your heart, but not heart failure · Left the hospital over 1 month ago but <3 months ago
|
78 Participants
n=93 Participants
|
85 Participants
n=4 Participants
|
163 Participants
n=27 Participants
|
|
Health care services
When was last time you were in hospital for your heart, but not heart failure · Longer than 3 months ago
|
352 Participants
n=93 Participants
|
346 Participants
n=4 Participants
|
698 Participants
n=27 Participants
|
|
Health care services
When was last time you were in hospital for your heart, but not heart failure · Don't remember or never been in hospital
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Heart failure etiology
Ischemic
|
265 Participants
n=93 Participants
|
259 Participants
n=4 Participants
|
524 Participants
n=27 Participants
|
|
Heart failure etiology
Idiopathic
|
97 Participants
n=93 Participants
|
101 Participants
n=4 Participants
|
198 Participants
n=27 Participants
|
|
Heart failure etiology
Hypertensive
|
49 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Heart failure etiology
Valvular heart disease
|
82 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Heart failure etiology
Alcoholic
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Heart failure etiology
Postpardum
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Heart failure etiology
Chemotherapy
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Heart failure etiology
Other
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ejection fraction %
|
41.3 % of blood ejected with each contraction
STANDARD_DEVIATION 17.2 • n=93 Participants
|
42.0 % of blood ejected with each contraction
STANDARD_DEVIATION 16.8 • n=4 Participants
|
41.6 % of blood ejected with each contraction
STANDARD_DEVIATION 17.0 • n=27 Participants
|
|
Cardiac devices at admission or before hospital discharge
ICD (Implantable Cardioverter Defibrillator)
|
88 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
172 Participants
n=27 Participants
|
|
Cardiac devices at admission or before hospital discharge
CRT (Cardiac Resynchronization Therapy)
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Cardiac devices at admission or before hospital discharge
CRT-D (Cardiac Resynchronization Therapy with Pacemaker)
|
45 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Cardiac devices at admission or before hospital discharge
DDD pacemaker (dual-chamber pacemaker)
|
27 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Cardiac devices at admission or before hospital discharge
AAI pacemaker (single chamber pacemaker operates in AAI mode)
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Cardiac devices at admission or before hospital discharge
None
|
332 Participants
n=93 Participants
|
333 Participants
n=4 Participants
|
665 Participants
n=27 Participants
|
|
Cardiac devices at admission or before hospital discharge
Other
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Drug classes at discharge
Angiotensin-converting enzyne inhibitors (ACE-i)
|
145 Participants
n=93 Participants
|
117 Participants
n=4 Participants
|
262 Participants
n=27 Participants
|
|
Drug classes at discharge
Angiotensin receptor neprilysin inhibitor (ARNI)
|
29 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Drug classes at discharge
Angiotensin receptor blocker (ARB)
|
67 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
125 Participants
n=27 Participants
|
|
Drug classes at discharge
Beta blocker
|
398 Participants
n=93 Participants
|
401 Participants
n=4 Participants
|
799 Participants
n=27 Participants
|
|
Drug classes at discharge
Aldosterone antagonist
|
136 Participants
n=93 Participants
|
129 Participants
n=4 Participants
|
265 Participants
n=27 Participants
|
|
Drug classes at discharge
Sinus node funny channel inhibitor
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Drug classes at discharge
Statin
|
321 Participants
n=93 Participants
|
328 Participants
n=4 Participants
|
649 Participants
n=27 Participants
|
|
Drug classes at discharge
Hydralazine
|
87 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
190 Participants
n=27 Participants
|
|
Drug classes at discharge
Nitrate
|
150 Participants
n=93 Participants
|
171 Participants
n=4 Participants
|
321 Participants
n=27 Participants
|
|
Drug classes at discharge
Digoxin
|
77 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
145 Participants
n=27 Participants
|
|
Drug classes at discharge
Loop diuretic
|
457 Participants
n=93 Participants
|
449 Participants
n=4 Participants
|
906 Participants
n=27 Participants
|
|
Drug classes at discharge
Thiazide or Thiazide like diuretic
|
15 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Charlson Comorbidity Index
>1.5 but <2.5
|
193 Participants
n=93 Participants
|
163 Participants
n=4 Participants
|
356 Participants
n=27 Participants
|
|
Charlson Comorbidity Index
>2.5 but <3.5
|
140 Participants
n=93 Participants
|
161 Participants
n=4 Participants
|
301 Participants
n=27 Participants
|
|
Charlson Comorbidity Index
>3.5 but <4.5
|
97 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
183 Participants
n=27 Participants
|
|
Charlson Comorbidity Index
>4.5 but <6.5
|
65 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
130 Participants
n=27 Participants
|
|
Charlson Comorbidity Index
>6.5
|
11 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 30 dayPopulation: Some patients were not included in the 30 day data due to heart failure related death, LVAD, or heart transplant.
Number of patients re-hospitalized with heart failure.
Outcome measures
| Measure |
MyRoad
n=496 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=475 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Number of Patients Rehospitalized With Heart Failure
Rehospitalized
|
71 Participants
|
78 Participants
|
|
Number of Patients Rehospitalized With Heart Failure
Not rehospitalized
|
425 Participants
|
397 Participants
|
SECONDARY outcome
Timeframe: Discharge from hospitalAdherence to 7-day follow-up appointment with a healthcare provider; by medical record chart review
Outcome measures
| Measure |
MyRoad
n=506 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=491 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge
|
290 Participants
|
285 Participants
|
SECONDARY outcome
Timeframe: BaselineQuality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire that measures physical limitations, symptoms, self-efficacy, social interference and quality of life. The KCCQ is a standardized score from 0 to 100 points. A score of 0 is the lowest quality of life (poor) and score of 100 is the highest quality of life.
Outcome measures
| Measure |
MyRoad
n=506 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=491 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Quality of Life (Health Status)
|
46.1 score on a scale
Standard Deviation 17.0
|
45.5 score on a scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: 45 dayPopulation: The number analyzed in both groups was lower than the number enrolled due to being unable to reach patients by phone for follow-up or the patient was deceased.
Quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire that measures physical limitations, symptoms, self-efficacy, social interference and quality of life. The KCCQ is a standardized score from 0 to 100 points. A score of 0 is the lowest quality of life (poor) and score of 100 is the highest quality of life.
Outcome measures
| Measure |
MyRoad
n=470 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=433 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Quality of Life (Health Status)
|
62.6 score on a scale
Standard Deviation 21.4
|
64.5 score on a scale
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: Baseline29-item list of heart failure-related symptoms. Patients were asked to consider any symptoms they experienced in the last 2 weeks and choose all that apply. Patients could also check "do not weigh self" and "no signs or symptoms of anything abnormal". The median \[Q1, Q3\] number of symptoms was reported between groups.
Outcome measures
| Measure |
MyRoad
n=506 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=491 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Symptoms
|
8.0 Symptoms
Interval 5.0 to 11.0
|
8.0 Symptoms
Interval 5.0 to 11.0
|
SECONDARY outcome
Timeframe: 45 daysPopulation: The number analyzed in both groups was lower than the number enrolled due to being unable to reach patients by phone for follow-up or the patient was deceased.
29-item list of heart failure-related symptoms. Patients were asked to consider any symptoms they experienced in the last 2 weeks and choose all that apply. Patients could also check "do not weigh self" and "no signs or symptoms of anything abnormal". The median \[Q1, Q3\] number of symptoms was reported between groups.
Outcome measures
| Measure |
MyRoad
n=471 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=434 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Symptoms
|
4.0 Symptoms
Interval 2.0 to 6.0
|
4.0 Symptoms
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Patients enrolled in the study were later excluded (e.g., due to death, discharged to Skilled Nursing Facility, dialysis, or left ventricular assist device).
Duke Activity Status Index (DASI) is a 12-item questionnaire using Likert scale that determines a patient's ability to participate in common, everyday activities without difficulty including self-care activities (e.g., ambulation, housework, yard work, sexual relations, and recreational activities. This is a patient-reported tool that measures functional status in patients with heart failure. Scores range from 0 (no functional capacity = worst score) to 58.2 (highest functional capacity = best score).
Outcome measures
| Measure |
MyRoad
n=506 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=491 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Functional Status
|
19.7 score on a scale
Standard Deviation 11.1
|
19.0 score on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: 45 dayPopulation: The number analyzed in both groups was lower than the number enrolled due to being unable to reach patients by phone or the patient was deceased (medical record chart review).
Duke Activity Status Index (DASI) is a 12-item questionnaire. This is a patient-reported tool that measures functional status in patients with heart failure. Patients were called by telephone and asked to rate their ability to do daily activities (e.g., personal care, ambulation, household tasks, sexual function, and recreation). Scores range from 0 (no functional capacity = worst score) to 58.2 (highest functional capacity = best score).
Outcome measures
| Measure |
MyRoad
n=470 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=433 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Functional Status
|
18.1 score on a scale
Standard Deviation 10.5
|
18.3 score on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Patients enrolled in the study were later excluded (e.g., due to death, discharged to a Skilled Nursing Facility, dialysis, or left ventricular assist device).
Modified PACE tool; used in previous research. Patients were asked to self-report their perceived adherence to activity recommendations by selecting the option on a checklist that matched their activity level.
Outcome measures
| Measure |
MyRoad
n=467 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=433 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Adherence to Activity Recommendations
Walk 2/week <10 minutes
|
17 Participants
|
14 Participants
|
|
Adherence to Activity Recommendations
Walk 2/week >10 minutes
|
12 Participants
|
16 Participants
|
|
Adherence to Activity Recommendations
Walk 3-5 days/week for 10-20 minutes
|
15 Participants
|
6 Participants
|
|
Adherence to Activity Recommendations
I do not walk now
|
164 Participants
|
165 Participants
|
|
Adherence to Activity Recommendations
I've been thinking of starting
|
207 Participants
|
176 Participants
|
|
Adherence to Activity Recommendations
Walk 3-5 days/week <10 minutes
|
7 Participants
|
11 Participants
|
|
Adherence to Activity Recommendations
Walk 3-5 days/week >20 minutes
|
7 Participants
|
12 Participants
|
|
Adherence to Activity Recommendations
Walk 6-7 days/week <10 minutes
|
2 Participants
|
3 Participants
|
|
Adherence to Activity Recommendations
Walk 6-7 days/week for 10-20 minutes
|
7 Participants
|
8 Participants
|
|
Adherence to Activity Recommendations
Walk 6-7 days/week >20 minutes
|
6 Participants
|
4 Participants
|
|
Adherence to Activity Recommendations
Began moderate or vigorous exercise <3 x week
|
5 Participants
|
3 Participants
|
|
Adherence to Activity Recommendations
Moderate exercise 3+ per week the last 1-6 months
|
6 Participants
|
8 Participants
|
|
Adherence to Activity Recommendations
Moderate exercise 3+ week for 7 months
|
8 Participants
|
6 Participants
|
|
Adherence to Activity Recommendations
Vigorous exercise 3-5 week for 1-6 months
|
1 Participants
|
1 Participants
|
|
Adherence to Activity Recommendations
Vigorous exercise 3-5 week >12 months
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 45 dayPopulation: Patients enrolled in the study were later excluded (e.g., due to death, discharged to Skilled Nursing Facility, dialysis, or left ventricular assist device).
Modified PACE tool; used in previous research. Patient's were contacted by telephone and asked to self-report their perceived adherence to activity recommendations.
Outcome measures
| Measure |
MyRoad
n=467 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=433 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Adherence to Activity Recommendations
Walk 3-5 days/week for 10-20 minutes
|
20 Participants
|
14 Participants
|
|
Adherence to Activity Recommendations
Walk 3-5 days/week >20 minutes
|
6 Participants
|
11 Participants
|
|
Adherence to Activity Recommendations
I do not walk now
|
186 Participants
|
161 Participants
|
|
Adherence to Activity Recommendations
I've been thinking of starting
|
162 Participants
|
148 Participants
|
|
Adherence to Activity Recommendations
Walk 2/week <10 minutes
|
8 Participants
|
7 Participants
|
|
Adherence to Activity Recommendations
Walk 2/week >10 minutes
|
12 Participants
|
11 Participants
|
|
Adherence to Activity Recommendations
Walk 3-5 days/week <10 minutes
|
15 Participants
|
17 Participants
|
|
Adherence to Activity Recommendations
Walk 6-7 days/week <10 minutes
|
11 Participants
|
10 Participants
|
|
Adherence to Activity Recommendations
Walk 6-7 days/week for 10-20 minutes
|
10 Participants
|
20 Participants
|
|
Adherence to Activity Recommendations
Walk 6-7 days/week >20 minutes
|
10 Participants
|
8 Participants
|
|
Adherence to Activity Recommendations
Began moderate or vigorous exercise <3 x week
|
10 Participants
|
8 Participants
|
|
Adherence to Activity Recommendations
Moderate exercise 3+ per week the last 1-6 months
|
12 Participants
|
14 Participants
|
|
Adherence to Activity Recommendations
Moderate exercise 3+ week for 7 months
|
3 Participants
|
4 Participants
|
|
Adherence to Activity Recommendations
Vigorous exercise 3-5 week for 1-6 months
|
1 Participants
|
0 Participants
|
|
Adherence to Activity Recommendations
Vigorous exercise 3-5 week >12 months
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record or the patient was deceased.
All-cause re-hospitalization, death, left ventricular assist device (LVAD), or cardiac transplant via medical record chart review; interview (telephone call).
Outcome measures
| Measure |
MyRoad
n=503 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=488 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
|
243 Participants
|
262 Participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record or the patient was deceased.
All-cause re-hospitalization, death, left ventricular assist device (LVAD), or cardiac transplant via medical record chart review; interview (telephone call).
Outcome measures
| Measure |
MyRoad
n=497 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=483 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
|
331 Participants
|
322 Participants
|
SECONDARY outcome
Timeframe: 45 daysPopulation: The number analyzed in both groups was lower than the number enrolled due to being unable to reach patients by phone for follow-up or the patient was deceased.
Number of patients rehospitalized with heart failure via chart review; interview (telephone call).
Outcome measures
| Measure |
MyRoad
n=485 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=465 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Number of Patients Rehospitalized With Heart Failure
|
91 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record chart.
Number of patients rehospitalized with heart failure via chart review
Outcome measures
| Measure |
MyRoad
n=458 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=440 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Number of Patients Rehospitalized With Heart Failure
|
135 Participants
|
138 Participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: The number analyzed in both groups was lower than the number enrolled due to being unable to locate information in the medical record chart.
Number of patients rehospitalized with heart failure via chart review; interview (telephone call).
Outcome measures
| Measure |
MyRoad
n=421 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=400 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Number of Patients Rehospitalized With Heart Failure
|
192 participants
|
183 participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: patients enrolled and discharged from the hospital alive; that we were able to obtain 180 day data on, assessed treatment group compared to usual care group
Number of patients with all-cause rehospitalization, death, or emergency department visits within 180 days. Information is obtained via medical record chart review.
Outcome measures
| Measure |
MyRoad
n=497 Participants
Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.
on-demand audio messages of heart failure education themes
|
Usual Care
n=483 Participants
Receives usual care heart failure education before discharge
|
|---|---|---|
|
Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit
|
331 Participants
|
322 Participants
|
Adverse Events
MyRoad
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nancy M. Albert, PhD, CCNS, CCHFN, 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