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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL150160-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced usual care | Active Comparator | Home health aides in the enhanced usual care arm will receive a virtual heart failure training course. |
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| Intervention arm | Experimental | Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth app | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (0 days); at follow-up (90 days) |
| 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. | Baseline (0 days); at follow-up (90 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (0 days); at follow-up (90 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Visits to the Emergency Department | All-cause emergency department visits to any emergency department | Baseline (0 days); at follow-up (90 days) |
| Number of Readmissions to the Hospital | All-cause readmissions to any hospital |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madeline R Sterling, MD, MPH, MS | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VNS Health Partners in Care | New York | New York | 10017 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41213039 | Derived | Sterling MR, Espinosa CG, Vergez S, McDonald MV, Ringel J, Tobin JN, Banerjee S, Dell N, Kern LM, Safford MM. Home Health Aides Caring for Adults With Heart Failure: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2548121. doi: 10.1001/jamanetworkopen.2025.48121. | |
| 38740297 | Derived | Espinosa CG, Vergez S, McDonald MV, Safford MM, Cho J, Tobin JN, Mourad O, Marcus R, Joanna Bryan Ringel J, Banerjee S, Dell N, Feldman P, Sterling MR. Leveraging home health aides to improve outcomes in heart failure: A pilot study protocol. Contemp Clin Trials. 2024 Aug;143:107570. doi: 10.1016/j.cct.2024.107570. Epub 2024 May 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intervention Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (0 days); at follow-up (90 days) |
|
90 days from baseline survey
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Madeline Sterling | Weill Cornell Medicine | 646-962-5029 | mrs9012@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 22, 2025 | May 19, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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Data analyst will be blinded to study arm.
| Virtual training course | Behavioral | Virtual training course on heart failure for home health aides. |
|
| 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. | Baseline (0 days); at follow-up (90 days) |
| Baseline (0 days); at follow-up (90 days) |
| 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. | Baseline (0 days); at follow-up (90 days) |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Foreign-Born | Count of Participants | Participants |
|
| Primary Language | Count of Participants | Participants |
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| Years as Home Health Aide | Count of Participants | Participants |
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| Number of Home Care Agencies worked for in the past | Count of Participants | Participants |
|
| Years worked at their current agency | Count of Participants | Participants |
|
| Number of Heart Failure Patients Cared for | Count of Participants | Participants |
|
| Hours per week spent with Heart Failure client | Count of Participants | Participants |
|
| Heart Failure Training | Count of Participants | Participants |
|
| Management (CC SCHFI) | Management is a subscale of the Caregiver Contribution to Self-Care in HF Index (CC SCHFI). The CC-SCHFI is a 22-item scale which measures caregivers' contributions to: HF maintenance, HF management, and HF caregiving self-efficacy (confidence). The management sub-scale ranges from 0-100. Higher scores indicate higher management. | Median | Inter-Quartile Range | units on a scale |
|
| Maintenance (CC SCHFI) | Maintenance is a subscale of the Caregiver Contribution to Self-Care in HF Index (CC SCHFI). The CC-SCHFI is a 22-item scale which measures caregivers' contributions to: HF maintenance, HF management, and HF caregiving self-efficacy (confidence). The maintenance sub-scale ranges from 0-100. Higher scores indicate higher maintenance. | Median | Inter-Quartile Range | units on a scale |
|
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.
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (0 days); at follow-up (90 days) |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (0 days); at follow-up (90 days) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (0 days); at follow-up (90 days) |
|
|
|
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| Other Pre-specified | Number of Visits to the Emergency Department | All-cause emergency department visits to any emergency department | Not Posted | Baseline (0 days); at follow-up (90 days) | Participants |
| Other Pre-specified | Number of Readmissions to the Hospital | All-cause readmissions to any hospital | Not Posted | Baseline (0 days); at follow-up (90 days) | Participants |
| 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. | 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. | Posted | Count of Participants | Participants | Baseline (0 days); at follow-up (90 days) |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. | 0 | 52 | 0 | 52 | 0 | 52 |
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| 90 days intention to leave job |
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| Baseline intention to search for a new job |
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| 90 days intention to search for a new job |
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A p<0.05 considered the threshold for statistical significance. |
| 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. | Regression, Logistic | 0.846 | Odds Ratio (OR) | 0.80 | 2-Sided | 95 | 0.08 | 7.72 | The comparison group is enhanced usual care arm | Equivalence | A p< 0.05 considered the threshold for statistical significance |
| 90 days-preventable 911 call if reached doctor |
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| Baseline-preventable 911 call if reached nurse/supervisor |
|
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| 90 days-preventable 911 call if reached nurse/supervisor |
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A p<0.05 was considered the threshold for statistical significance. |
| 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. | Regression, Logistic | 0.99 | Odds Ratio (OR) | 1.01 | 2-Sided | 95 | 0.22 | 4.58 | Equivalence | A p<0.05 considered the threshold for statistical significance. |