Leveraging Home Health Aides to Improve Outcomes in Heart Failure

NCT ID: NCT04239911

Last Updated: 2025-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-16

Study Completion Date

2024-08-17

Brief Summary

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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).

Detailed Description

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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

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Heart Failure Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Data analyst will be blinded to study arm.

Study Groups

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Enhanced usual care

Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.

Group Type ACTIVE_COMPARATOR

Virtual training course

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

mHealth app

Intervention Type 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.

Virtual training course

Intervention Type BEHAVIORAL

Virtual training course on heart failure for home health aides.

Interventions

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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.

Intervention Type BEHAVIORAL

Virtual training course

Virtual training course on heart failure for home health aides.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madeline R Sterling, MD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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VNS Health Partners in Care

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38740297 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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K23HL150160-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-08020553

Identifier Type: -

Identifier Source: org_study_id

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