Heart FailureNCT04239911
Leveraging Home Health Aides to Improve Outcomes in Heart Failure
A study testing mHealth app and Virtual training course in people with Heart Failure and Congestive Heart Failure, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive Heart Failure
- What is being tested?
- mHealth app and Virtual training course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 17 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Doesn't meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
VNS Health Partners in Care
New York, New York, 10017
About this study
Official title: Leveraging Home Health Aides to Improve Outcomes in Heart Failure: A Pilot Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Heart Failure, Congestive Heart Failure
- Being tested
- mHealth app, Virtual training course
- Keywords
- home health aides, home health care, home care agency
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth appBehavioural
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 courseBehavioural
Virtual training course on heart failure for home health aides.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced usual care | Active comparator | Home health aides in the enhanced usual care arm will receive a virtual heart failure training course. Receives: Behavioral: Virtual training course |
| Intervention arm | Experimental | Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app. Receives: Behavioral: mHealth app; Behavioral: Virtual training course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (0 days); at follow-up (90 days)
Secondary outcomes (2)
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.
Measured: Baseline (0 days); at follow-up (90 days)
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.
Measured: Baseline (0 days); at follow-up (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start16 May 2022
- Primary completion17 Aug 2024
- Study completion17 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Madeline R Sterling, MD, MPH, MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239911
- Sponsor's protocol ID
- 19-08020553
- Other IDs
- K23HL150160-01
- Status last verified
- May 2025
- First submitted
- 21 Jan 2020
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41213039Espinosa 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.
PubMed 38740297
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Home Health Aides to Improve Outcomes in Heart Failure: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04239911
- Acronym / sponsor ID
- 19-08020553
- Conditions
- Heart Failure, Congestive Heart Failure
- Keywords
- home health aides, home health care, home care agency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 17 Aug 2024 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care | Active comparator | Behavioral: Virtual training courseHome health aides in the enhanced usual care arm will receive a virtual heart failure training course. |
| Intervention arm | Experimental | Behavioral: mHealth app, Behavioral: Virtual training courseHome health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Doesn't meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth appThe 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. | Behavioural | Intervention arm |
| Virtual training courseVirtual training course on heart failure for home health aides. | Behavioural | Enhanced usual care, Intervention arm |
Primary outcome
Change in Heart Failure Knowledge
Time frame: 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
Time frame: 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.
2 secondary outcomes
Change in Job Satisfaction
Time frame: Baseline (0 days); at follow-up (90 days)
Change in Intention to Leave
Time frame: Baseline (0 days); at follow-up (90 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41213039Sterling 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.
- Derived from this study: PubMed 38740297Espinosa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madeline R Sterling, MD, MPH, MS principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth app and Virtual training course in people with Heart Failure and Congestive Heart Failure, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Failure Knowledge (time frame: Baseline (0 days); at follow-up (90 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04239911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.