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=99 Participants
|
73.1 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
72.8 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=99 Participants
|
206 Participants
n=107 Participants
|
412 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
300 Participants
n=99 Participants
|
285 Participants
n=107 Participants
|
585 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
123 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
243 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
375 Participants
n=99 Participants
|
362 Participants
n=107 Participants
|
737 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
506 participants
n=99 Participants
|
491 participants
n=107 Participants
|
997 participants
n=206 Participants
|
|
Marital status
Single
|
66 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Marital status
Married
|
255 Participants
n=99 Participants
|
239 Participants
n=107 Participants
|
494 Participants
n=206 Participants
|
|
Marital status
Divorced/Separated
|
66 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Marital status
Widowed
|
108 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
|
Marital status
Co-habitate (living with partner)
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Location
Main campus
|
288 Participants
n=99 Participants
|
282 Participants
n=107 Participants
|
570 Participants
n=206 Participants
|
|
Location
Hillcrest
|
115 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
231 Participants
n=206 Participants
|
|
Location
Fairview
|
73 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Location
Medina
|
30 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Do you currently live with another person?
Yes
|
390 Participants
n=99 Participants
|
374 Participants
n=107 Participants
|
764 Participants
n=206 Participants
|
|
Do you currently live with another person?
No
|
116 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
233 Participants
n=206 Participants
|
|
Do you have someone to confide in?
Yes
|
492 Participants
n=99 Participants
|
482 Participants
n=107 Participants
|
974 Participants
n=206 Participants
|
|
Do you have someone to confide in?
No
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Do you have someone to confide in?
Missing survey response
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Highest level of education completed
Less than high school graduate
|
75 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
|
Highest level of education completed
General Educational Development (GED)
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Highest level of education completed
High school graduate
|
182 Participants
n=99 Participants
|
172 Participants
n=107 Participants
|
354 Participants
n=206 Participants
|
|
Highest level of education completed
Some college or professional training post high school
|
131 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
274 Participants
n=206 Participants
|
|
Highest level of education completed
Associate degree
|
17 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Highest level of education completed
Bachelor's degree
|
61 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Highest level of education completed
Master's degree
|
24 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Highest level of education completed
Doctoral degree
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Employment status
Employed full or part-time
|
60 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Employment status
Unemployed by choice
|
22 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Employment status
Sick leave or disability
|
46 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Employment status
Retired due to HF
|
60 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Employment status
Retired, not due to HF
|
318 Participants
n=99 Participants
|
310 Participants
n=107 Participants
|
628 Participants
n=206 Participants
|
|
Employment status
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Consider how well you live on income
Comfortable, more than enough
|
158 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
295 Participants
n=206 Participants
|
|
Consider how well you live on income
Have enough to make ends meet
|
224 Participants
n=99 Participants
|
232 Participants
n=107 Participants
|
456 Participants
n=206 Participants
|
|
Consider how well you live on income
Do not have enough to make ends meet
|
124 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
246 Participants
n=206 Participants
|
|
In general, would you say your health is
Poor
|
135 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
254 Participants
n=206 Participants
|
|
In general, would you say your health is
Fair
|
200 Participants
n=99 Participants
|
222 Participants
n=107 Participants
|
422 Participants
n=206 Participants
|
|
In general, would you say your health is
Good
|
138 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
In general, would you say your health is
Very good
|
23 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
In general, would you say your health is
Excellent
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 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=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 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=99 Participants
|
40 Participants
n=107 Participants
|
90 Participants
n=206 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=99 Participants
|
43 Participants
n=107 Participants
|
102 Participants
n=206 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=99 Participants
|
126 Participants
n=107 Participants
|
251 Participants
n=206 Participants
|
|
Health care services
When was the last time you were in hospital for any reason? · Longer than 3 months ago
|
239 Participants
n=99 Participants
|
248 Participants
n=107 Participants
|
487 Participants
n=206 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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 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=99 Participants
|
32 Participants
n=107 Participants
|
68 Participants
n=206 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=99 Participants
|
36 Participants
n=107 Participants
|
86 Participants
n=206 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=99 Participants
|
97 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Health care services
When was the last time you were hospitalized for heart failure? · Longer than 3 months ago
|
300 Participants
n=99 Participants
|
292 Participants
n=107 Participants
|
592 Participants
n=206 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=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 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=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 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=99 Participants
|
15 Participants
n=107 Participants
|
39 Participants
n=206 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=99 Participants
|
21 Participants
n=107 Participants
|
48 Participants
n=206 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=99 Participants
|
85 Participants
n=107 Participants
|
163 Participants
n=206 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=99 Participants
|
346 Participants
n=107 Participants
|
698 Participants
n=206 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=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Heart failure etiology
Ischemic
|
265 Participants
n=99 Participants
|
259 Participants
n=107 Participants
|
524 Participants
n=206 Participants
|
|
Heart failure etiology
Idiopathic
|
97 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
198 Participants
n=206 Participants
|
|
Heart failure etiology
Hypertensive
|
49 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Heart failure etiology
Valvular heart disease
|
82 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Heart failure etiology
Alcoholic
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Heart failure etiology
Postpardum
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Heart failure etiology
Chemotherapy
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Heart failure etiology
Other
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ejection fraction %
|
41.3 % of blood ejected with each contraction
STANDARD_DEVIATION 17.2 • n=99 Participants
|
42.0 % of blood ejected with each contraction
STANDARD_DEVIATION 16.8 • n=107 Participants
|
41.6 % of blood ejected with each contraction
STANDARD_DEVIATION 17.0 • n=206 Participants
|
|
Cardiac devices at admission or before hospital discharge
ICD (Implantable Cardioverter Defibrillator)
|
88 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Cardiac devices at admission or before hospital discharge
CRT (Cardiac Resynchronization Therapy)
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Cardiac devices at admission or before hospital discharge
CRT-D (Cardiac Resynchronization Therapy with Pacemaker)
|
45 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Cardiac devices at admission or before hospital discharge
DDD pacemaker (dual-chamber pacemaker)
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Cardiac devices at admission or before hospital discharge
AAI pacemaker (single chamber pacemaker operates in AAI mode)
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Cardiac devices at admission or before hospital discharge
None
|
332 Participants
n=99 Participants
|
333 Participants
n=107 Participants
|
665 Participants
n=206 Participants
|
|
Cardiac devices at admission or before hospital discharge
Other
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Drug classes at discharge
Angiotensin-converting enzyne inhibitors (ACE-i)
|
145 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
262 Participants
n=206 Participants
|
|
Drug classes at discharge
Angiotensin receptor neprilysin inhibitor (ARNI)
|
29 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Drug classes at discharge
Angiotensin receptor blocker (ARB)
|
67 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Drug classes at discharge
Beta blocker
|
398 Participants
n=99 Participants
|
401 Participants
n=107 Participants
|
799 Participants
n=206 Participants
|
|
Drug classes at discharge
Aldosterone antagonist
|
136 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
265 Participants
n=206 Participants
|
|
Drug classes at discharge
Sinus node funny channel inhibitor
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Drug classes at discharge
Statin
|
321 Participants
n=99 Participants
|
328 Participants
n=107 Participants
|
649 Participants
n=206 Participants
|
|
Drug classes at discharge
Hydralazine
|
87 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
190 Participants
n=206 Participants
|
|
Drug classes at discharge
Nitrate
|
150 Participants
n=99 Participants
|
171 Participants
n=107 Participants
|
321 Participants
n=206 Participants
|
|
Drug classes at discharge
Digoxin
|
77 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Drug classes at discharge
Loop diuretic
|
457 Participants
n=99 Participants
|
449 Participants
n=107 Participants
|
906 Participants
n=206 Participants
|
|
Drug classes at discharge
Thiazide or Thiazide like diuretic
|
15 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Charlson Comorbidity Index
>1.5 but <2.5
|
193 Participants
n=99 Participants
|
163 Participants
n=107 Participants
|
356 Participants
n=206 Participants
|
|
Charlson Comorbidity Index
>2.5 but <3.5
|
140 Participants
n=99 Participants
|
161 Participants
n=107 Participants
|
301 Participants
n=206 Participants
|
|
Charlson Comorbidity Index
>3.5 but <4.5
|
97 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
183 Participants
n=206 Participants
|
|
Charlson Comorbidity Index
>4.5 but <6.5
|
65 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Charlson Comorbidity Index
>6.5
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 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
I've been thinking of starting
|
207 Participants
|
176 Participants
|
|
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 <10 minutes
|
7 Participants
|
11 Participants
|
|
Adherence to Activity Recommendations
Walk 3-5 days/week for 10-20 minutes
|
15 Participants
|
6 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
|
|
Adherence to Activity Recommendations
I do not walk now
|
164 Participants
|
165 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
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 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
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