Trial Outcomes & Findings for Leveraging Home Health Aides to Improve Outcomes in Heart Failure (NCT NCT04239911)
NCT ID: NCT04239911
Last Updated: 2025-06-06
Results Overview
As measured by the Dutch Heart Failure Knowledge Scale, scores range from 0-15; higher scores indicate greater heart failure knowledge.
COMPLETED
NA
105 participants
Baseline (0 days); at follow-up (90 days)
2025-06-06
Participant Flow
Participant milestones
| Measure |
Enhanced Usual Care
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Virtual training course: Virtual training course on heart failure for home health aides.
|
Intervention Arm
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
mHealth app: The mHealth app will provide heart failure-specific education to home health aides and allow them to report clinical observations and ask nurses questions in real-time.
Virtual training course: Virtual training course on heart failure for home health aides.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
|
Overall Study
COMPLETED
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Enhanced Usual Care
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Virtual training course: Virtual training course on heart failure for home health aides.
|
Intervention Arm
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
mHealth app: The mHealth app will provide heart failure-specific education to home health aides and allow them to report clinical observations and ask nurses questions in real-time.
Virtual training course: Virtual training course on heart failure for home health aides.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Leveraging Home Health Aides to Improve Outcomes in Heart Failure
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care
n=50 Participants
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Virtual training course: Virtual training course on heart failure for home health aides.
|
Intervention Arm
n=52 Participants
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
mHealth app: The mHealth app will provide heart failure-specific education to home health aides and allow them to report clinical observations and ask nurses questions in real-time.
Virtual training course: Virtual training course on heart failure for home health aides.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
54.8 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
54.0 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African-American
|
30 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing Information on Race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Education
No Degree or Some High School
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Education
Completed High School or GED
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Education
Some College
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Education
College Degree
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Education
Graduate Degree
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Education
Missing Information on Education
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Foreign-Born
Foreign-Born
|
45 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Foreign-Born
US-Born
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Primary Language
English
|
33 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Primary Language
Spanish
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Primary Language
Other
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Years as Home Health Aide
0-5 years
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Years as Home Health Aide
6-10 years
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Years as Home Health Aide
11-15 years
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Years as Home Health Aide
>15 years
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Number of Home Care Agencies worked for in the past
0-1 agency
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Number of Home Care Agencies worked for in the past
2 agencies
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Number of Home Care Agencies worked for in the past
greater than or equal to 3 agencies
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Years worked at their current agency
0-5 years
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Years worked at their current agency
6-10 years
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Years worked at their current agency
11-15 years
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Years worked at their current agency
greater than 15 years
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Years worked at their current agency
Missing Information
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Number of Heart Failure Patients Cared for
less than or equal to 5 Heart Failure Patients
|
38 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Number of Heart Failure Patients Cared for
greater than 5 Heart Failure Patients
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Number of Heart Failure Patients Cared for
not sure
|
6 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Hours per week spent with Heart Failure client
1-5 hours per week
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Hours per week spent with Heart Failure client
6-10 hours per week
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Hours per week spent with Heart Failure client
11-20 hours per week
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Hours per week spent with Heart Failure client
Greater than 20 hours per week
|
16 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Hours per week spent with Heart Failure client
Not Sure
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Hours per week spent with Heart Failure client
Missing Information
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Heart Failure Training
None
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Heart Failure Training
A little
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Heart Failure Training
Some
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Heart Failure Training
A lot
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Management (CC SCHFI)
|
60 units on a scale
n=99 Participants
|
55 units on a scale
n=107 Participants
|
60 units on a scale
n=206 Participants
|
|
Maintenance (CC SCHFI)
|
86.7 units on a scale
n=99 Participants
|
86.7 units on a scale
n=107 Participants
|
86.7 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 days); at follow-up (90 days)Population: Of the 105 participants that consented to be in the study, 3 participants were lost to follow-up between consents and taking the baseline survey.
As measured by the Dutch Heart Failure Knowledge Scale, scores range from 0-15; higher scores indicate greater heart failure knowledge.
Outcome measures
| Measure |
Enhanced Usual Care
n=50 Participants
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Virtual training course: Virtual training course on heart failure for home health aides.
|
Intervention Arm
n=52 Participants
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
mHealth app: The mHealth app will provide heart failure-specific education to home health aides and allow them to report clinical observations and ask nurses questions in real-time.
Virtual training course: Virtual training course on heart failure for home health aides.
|
|---|---|---|
|
Change in Heart Failure Knowledge
|
0.93 units on a scale
Interval 0.05 to 1.81
|
1.88 units on a scale
Interval 1.05 to 2.71
|
PRIMARY outcome
Timeframe: Baseline (0 days); at follow-up (90 days)Population: Of the 105 participants that consented to be in the study, 3 participants were lost to follow-up between consents and taking the baseline survey.
As measured by the Caregiver Contribution to Self-Care in Heart Failure Index, which is a 22-item scale which assesses maintenance, management, and self-efficacy sub-scales separately. Each sub-scale score ranges from 0-100, with greater scores indicating greater contribution to care or self-efficacy.
Outcome measures
| Measure |
Enhanced Usual Care
n=50 Participants
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Virtual training course: Virtual training course on heart failure for home health aides.
|
Intervention Arm
n=52 Participants
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
mHealth app: The mHealth app will provide heart failure-specific education to home health aides and allow them to report clinical observations and ask nurses questions in real-time.
Virtual training course: Virtual training course on heart failure for home health aides.
|
|---|---|---|
|
Change in Heart Failure Caregiving Self-efficacy
|
1.27 units on a scale
Interval -3.71 to 6.24
|
1.44 units on a scale
Interval -3.49 to 6.36
|
SECONDARY outcome
Timeframe: Baseline (0 days); at follow-up (90 days)Population: Of the 105 participants that consented to be in the study, 3 participants were lost to follow-up between consents and taking the baseline survey.
As measured by the Work Domain Satisfaction Scale, which is a 5-item scale that measures: 1) job satisfaction among care workers; and 2) examines the associations with work environment factors, work stressors, and health issues. Scores range from 5-20, with higher scores indicating stronger satisfaction.
Outcome measures
| Measure |
Enhanced Usual Care
n=50 Participants
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Virtual training course: Virtual training course on heart failure for home health aides.
|
Intervention Arm
n=52 Participants
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
mHealth app: The mHealth app will provide heart failure-specific education to home health aides and allow them to report clinical observations and ask nurses questions in real-time.
Virtual training course: Virtual training course on heart failure for home health aides.
|
|---|---|---|
|
Change in Job Satisfaction
|
0.12 units on a scale
Interval -1.56 to 1.79
|
-0.31 units on a scale
Interval -1.95 to 1.33
|
SECONDARY outcome
Timeframe: Baseline (0 days); at follow-up (90 days)Population: Of the 105 participants that consented to be in the study, 3 participants were lost to follow-up between consents and taking the baseline survey. For non-modeled comparison of count of participants who were thinking of leaving job at 90 days, not all participants responded to the question regarding intentions of 1) leaving their current job and 2) searching for a new job in the baseline survey. Additionally, not all of these participants completed these questions for the 90-day follow-up.
As measured by the Turnover Intention Scale, which is a 2-item scale that measures workers' intentions of 1) leaving their current job (at their agency) and 2) searching for a new job (in another field) in the next year. ) Responses for both included a 7-point likert scale of: very strongly disagree, strongly disagree, disagree neutral, agree, strongly agree, very strongly agree. Both questions were dichotomized into "agree", "strongly agree", and "very strongly" vs. all other responses.
Outcome measures
| Measure |
Enhanced Usual Care
n=48 Participants
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Virtual training course: Virtual training course on heart failure for home health aides.
|
Intervention Arm
n=50 Participants
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
mHealth app: The mHealth app will provide heart failure-specific education to home health aides and allow them to report clinical observations and ask nurses questions in real-time.
Virtual training course: Virtual training course on heart failure for home health aides.
|
|---|---|---|
|
Change in Intention to Leave
Baseline intention to leave job
|
10 Participants
|
9 Participants
|
|
Change in Intention to Leave
90 days intention to leave job
|
6 Participants
|
6 Participants
|
|
Change in Intention to Leave
Baseline intention to search for a new job
|
6 Participants
|
5 Participants
|
|
Change in Intention to Leave
90 days intention to search for a new job
|
3 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (0 days); at follow-up (90 days)All-cause emergency department visits to any emergency department
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (0 days); at follow-up (90 days)All-cause readmissions to any hospital
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (0 days); at follow-up (90 days)Population: Of the 105 participants that consented to be in the study, 3 participants were lost to follow-up between consents and taking the baseline survey. For non-modeled comparison of count of participants who were thinking of leaving job at 90 days, not all participants responded to the questions regarding preventable 911 calls in baseline survey. Additionally, not all participants responded to preventable 911 call questions at 90-day follow-up.
Preventable 911 calls were assessed with 2-close ended questions that we previously used among HHAs: "I have called 911 when that could have been prevented if I had been able to reach my supervisor/the nurse." and "I have called 911 when that could have been prevented if my supervisor and I had been able to reach the client's doctor." Responses for both included a 7-point Likert scale of: very strongly disagree, strongly disagree, disagree neutral, agree, strongly agree, very strongly agree. Both questions dichotomized into "agree", "strongly agree", and "very strongly" vs. all other responses.
Outcome measures
| Measure |
Enhanced Usual Care
n=50 Participants
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Virtual training course: Virtual training course on heart failure for home health aides.
|
Intervention Arm
n=52 Participants
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
mHealth app: The mHealth app will provide heart failure-specific education to home health aides and allow them to report clinical observations and ask nurses questions in real-time.
Virtual training course: Virtual training course on heart failure for home health aides.
|
|---|---|---|
|
Change in Preventable 911 Calls
Baseline-preventable 911 call if reached doctor
|
20 Participants
|
26 Participants
|
|
Change in Preventable 911 Calls
90 days-preventable 911 call if reached doctor
|
19 Participants
|
13 Participants
|
|
Change in Preventable 911 Calls
Baseline-preventable 911 call if reached nurse/supervisor
|
30 Participants
|
28 Participants
|
|
Change in Preventable 911 Calls
90 days-preventable 911 call if reached nurse/supervisor
|
18 Participants
|
18 Participants
|
Adverse Events
Enhanced Usual Care
Intervention Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place