Congestive Heart Failure, Heart Failure
Conditions
Keywords
home health aides, home health care, home care agency
Brief summary
The purpose of the study is to determine the effectiveness of an intervention among home health aides caring for adults admitted to home care with a primary diagnosis of heart failure at VNS Health Partners in Care (home care agency). The study will examine the interventions' effect on home health aides' heart failure knowledge and confidence caring for adults with heart failure, as well as on the client's overall health (visits to the emergency department and hospital readmissions).
Detailed description
The investigator's central hypothesis is that an intervention that can optimize and improve the experience of home health aides caring for the heart failure patients has the potential to improve home health aides' own self-efficacy, heart failure knowledge, and also patient outcomes. The intervention for home health aides is comprised of a) remote classroom education on heart failure and b) an mHealth app containing HF educational content and a messaging application that connects HHAs and their nurse supervisors. This intervention requires feasibility and acceptability testing, as well as preliminary testing of its effectiveness among home health aides caring for community-dwelling adults with heart failure.
Interventions
BEHAVIORALmHealth 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.
BEHAVIORALVirtual training course
Virtual training course on heart failure for home health aides.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analyst will be blinded to study arm.
Intervention model description
104 home health aides will be recruited from VNS Health and randomized to either enhanced usual care arm (heart failure training course; n = 52) or the intervention (heart failure training course plus mHealth app; n =52). Four nurses will also be recruited to the study. The total duration of each home health aides' involvement will be 90 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Home health aide employed at VNS Health Partners in Care home care agency. * 1 or more years of experience as a home health aide. * Speak English or Spanish. * Assigned to care for an adult admitted to home care with a primary diagnosis of heart failure.
Exclusion criteria
* Doesn't meet inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Failure Knowledge | Baseline (0 days); at follow-up (90 days) | As measured by the Dutch Heart Failure Knowledge Scale, scores range from 0-15; higher scores indicate greater heart failure knowledge. |
| Change in Heart Failure Caregiving Self-efficacy | Baseline (0 days); at follow-up (90 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Job Satisfaction | Baseline (0 days); at follow-up (90 days) | 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. |
| Change in Intention to Leave | Baseline (0 days); at follow-up (90 days) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Readmissions to the Hospital | Baseline (0 days); at follow-up (90 days) | All-cause readmissions to any hospital |
| Change in Preventable 911 Calls | Baseline (0 days); at follow-up (90 days) | 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. |
| Number of Visits to the Emergency Department | Baseline (0 days); at follow-up (90 days) | All-cause emergency department visits to any emergency department |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 52 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Enhanced Usual Care | Intervention Arm |
|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 10.5 | 53.2 years STANDARD_DEVIATION 10.9 | 54.8 years STANDARD_DEVIATION 10.2 |
| Education College Degree | 17 Participants | 8 Participants | 9 Participants |
| Education Completed High School or GED | 36 Participants | 18 Participants | 18 Participants |
| Education Graduate Degree | 7 Participants | 2 Participants | 5 Participants |
| Education Missing Information on Education | 1 Participants | 1 Participants | 0 Participants |
| Education No Degree or Some High School | 21 Participants | 9 Participants | 12 Participants |
| Education Some College | 20 Participants | 12 Participants | 8 Participants |
| Foreign-Born Foreign-Born | 88 Participants | 45 Participants | 43 Participants |
| Foreign-Born US-Born | 14 Participants | 5 Participants | 9 Participants |
| Heart Failure Training A little | 31 Participants | 13 Participants | 18 Participants |
| Heart Failure Training A lot | 2 Participants | 0 Participants | 2 Participants |
| Heart Failure Training None | 46 Participants | 24 Participants | 22 Participants |
| Heart Failure Training Some | 23 Participants | 13 Participants | 10 Participants |
| Hours per week spent with Heart Failure client 11-20 hours per week | 12 Participants | 6 Participants | 6 Participants |
| Hours per week spent with Heart Failure client 1-5 hours per week | 15 Participants | 9 Participants | 6 Participants |
| Hours per week spent with Heart Failure client 6-10 hours per week | 34 Participants | 14 Participants | 20 Participants |
| Hours per week spent with Heart Failure client Greater than 20 hours per week | 25 Participants | 16 Participants | 9 Participants |
| Hours per week spent with Heart Failure client Missing Information | 2 Participants | 1 Participants | 1 Participants |
| Hours per week spent with Heart Failure client Not Sure | 14 Participants | 4 Participants | 10 Participants |
| Maintenance (CC SCHFI) | 86.7 units on a scale | 86.7 units on a scale | 86.7 units on a scale |
| Management (CC SCHFI) | 60 units on a scale | 60 units on a scale | 55 units on a scale |
| Number of Heart Failure Patients Cared for greater than 5 Heart Failure Patients | 18 Participants | 6 Participants | 12 Participants |
| Number of Heart Failure Patients Cared for less than or equal to 5 Heart Failure Patients | 65 Participants | 38 Participants | 27 Participants |
| Number of Heart Failure Patients Cared for not sure | 19 Participants | 6 Participants | 13 Participants |
| Number of Home Care Agencies worked for in the past 0-1 agency | 53 Participants | 26 Participants | 27 Participants |
| Number of Home Care Agencies worked for in the past 2 agencies | 33 Participants | 17 Participants | 16 Participants |
| Number of Home Care Agencies worked for in the past greater than or equal to 3 agencies | 16 Participants | 7 Participants | 9 Participants |
| Primary Language English | 65 Participants | 33 Participants | 32 Participants |
| Primary Language Other | 17 Participants | 6 Participants | 11 Participants |
| Primary Language Spanish | 20 Participants | 11 Participants | 9 Participants |
| Race/Ethnicity, Customized African-American | 62 Participants | 30 Participants | 32 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Missing Information on Race | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 21 Participants | 9 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Female | 98 Participants | 48 Participants | 50 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 2 Participants |
| Years as Home Health Aide 0-5 years | 28 Participants | 13 Participants | 15 Participants |
| Years as Home Health Aide 11-15 years | 16 Participants | 9 Participants | 7 Participants |
| Years as Home Health Aide >15 years | 27 Participants | 14 Participants | 13 Participants |
| Years as Home Health Aide 6-10 years | 31 Participants | 14 Participants | 17 Participants |
| Years worked at their current agency 0-5 years | 35 Participants | 16 Participants | 19 Participants |
| Years worked at their current agency 11-15 years | 18 Participants | 10 Participants | 8 Participants |
| Years worked at their current agency 6-10 years | 34 Participants | 16 Participants | 18 Participants |
| Years worked at their current agency greater than 15 years | 14 Participants | 8 Participants | 6 Participants |
| Years worked at their current agency Missing Information | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 52 |
| other Total, other adverse events | 0 / 50 | 0 / 52 |
| serious Total, serious adverse events | 0 / 50 | 0 / 52 |
Outcome results
Primary
Change in Heart Failure Caregiving Self-efficacy
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Usual Care | Change in Heart Failure Caregiving Self-efficacy | 1.27 units on a scale |
| Intervention Arm | Change in Heart Failure Caregiving Self-efficacy | 1.44 units on a scale |
Primary
Change in Heart Failure Knowledge
As measured by the Dutch Heart Failure Knowledge Scale, scores range from 0-15; higher scores indicate greater heart failure knowledge.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Usual Care | Change in Heart Failure Knowledge | 0.93 units on a scale |
| Intervention Arm | Change in Heart Failure Knowledge | 1.88 units on a scale |
Secondary
Change in Intention to Leave
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Usual Care | Change in Intention to Leave | Baseline intention to leave job | 10 Participants |
| Enhanced Usual Care | Change in Intention to Leave | 90 days intention to leave job | 6 Participants |
| Enhanced Usual Care | Change in Intention to Leave | Baseline intention to search for a new job | 6 Participants |
| Enhanced Usual Care | Change in Intention to Leave | 90 days intention to search for a new job | 3 Participants |
| Intervention Arm | Change in Intention to Leave | 90 days intention to search for a new job | 3 Participants |
| Intervention Arm | Change in Intention to Leave | Baseline intention to leave job | 9 Participants |
| Intervention Arm | Change in Intention to Leave | Baseline intention to search for a new job | 5 Participants |
| Intervention Arm | Change in Intention to Leave | 90 days intention to leave job | 6 Participants |
Comparison: Outcome measures workers' intentions of leaving their current job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept.p-value: 0.97495% CI: [0.14, 6.85]Regression, Logistic
Comparison: Outcome measures workers' intentions of searching for a new job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept.p-value: 0.84695% CI: [0.08, 7.72]Regression, Logistic
Secondary
Change in Job Satisfaction
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Usual Care | Change in Job Satisfaction | 0.12 units on a scale |
| Intervention Arm | Change in Job Satisfaction | -0.31 units on a scale |
Other Pre-specified
Change in Preventable 911 Calls
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Usual Care | Change in Preventable 911 Calls | Baseline-preventable 911 call if reached doctor | 20 Participants |
| Enhanced Usual Care | Change in Preventable 911 Calls | 90 days-preventable 911 call if reached doctor | 19 Participants |
| Enhanced Usual Care | Change in Preventable 911 Calls | Baseline-preventable 911 call if reached nurse/supervisor | 30 Participants |
| Enhanced Usual Care | Change in Preventable 911 Calls | 90 days-preventable 911 call if reached nurse/supervisor | 18 Participants |
| Intervention Arm | Change in Preventable 911 Calls | 90 days-preventable 911 call if reached nurse/supervisor | 18 Participants |
| Intervention Arm | Change in Preventable 911 Calls | Baseline-preventable 911 call if reached doctor | 26 Participants |
| Intervention Arm | Change in Preventable 911 Calls | Baseline-preventable 911 call if reached nurse/supervisor | 28 Participants |
| Intervention Arm | Change in Preventable 911 Calls | 90 days-preventable 911 call if reached doctor | 13 Participants |
Comparison: Preventable 911 calls if had been able to reach the doctor. Dichotomized into agree, strongly agree, and very strongly vs. all other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept.p-value: 0.04395% CI: [0.03, 0.94]Regression, Logistic
Comparison: Preventable 911 calls if had been able to reach the nurse/supervisor. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept.p-value: 0.9995% CI: [0.22, 4.58]Regression, Logistic
Other Pre-specified
Number of Readmissions to the Hospital
All-cause readmissions to any hospital
Time frame: Baseline (0 days); at follow-up (90 days)
Other Pre-specified
Number of Visits to the Emergency Department
All-cause emergency department visits to any emergency department
Time frame: Baseline (0 days); at follow-up (90 days)