Leveraging Home Health Aides to Improve Outcomes in Heart Failure

NCT04239911 | Completed Results

• 2 other identifiers: 19-08020553K23HL150160-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure; Congestive Heart Failure

Keywords

home health aides; home health care; home care agency

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• Change in Job Satisfaction

  Baseline (0 days); at follow-up (90 days)

• Change in Intention to Leave

  Baseline (0 days); at follow-up (90 days)

Other Outcomes (3)

• Number of Visits to the Emergency Department

  Baseline (0 days); at follow-up (90 days)

• Number of Readmissions to the Hospital

  Baseline (0 days); at follow-up (90 days)

• Change in Preventable 911 Calls

  Baseline (0 days); at follow-up (90 days)

Study Arms (2)

Enhanced usual care

ACTIVE COMPARATOR

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

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.

Behavioral: mHealth app; Behavioral: Virtual training course

Interventions

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.

Intervention arm

Virtual training course BEHAVIORAL

Virtual training course on heart failure for home health aides.

Enhanced usual care; Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Home health aide employed at VNS Health Partners in Care home care agency.
• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

VNS Health Partners in Care

New York, New York, 10017, United States

Location

Related Publications (2)

• 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.

  PMID: 41213039 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.

  PMID: 38740297 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Madeline Sterling
• Organization: Weill Cornell Medicine

mrs9012@med.cornell.edu

646-962-5029

Study Officials

• Madeline R Sterling, MD, MPH, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analyst will be blinded to study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: May 16, 2022
• Primary Completion: August 17, 2024
• Study Completion: August 17, 2024
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)