Leveraging Home Health Aides to Improve Outcomes in Heart Failure

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure; Congestive Heart Failure
• Intervention / Treatment: Behavioral: Virtual training course; Behavioral: mHealth app

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • VNS Health Partners in Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced usual care; Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.	Behavioral: Virtual training course; Virtual training course on heart failure for home health aides.
Experimental: Intervention arm; Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.	Behavioral: Virtual training course; Virtual training course on heart failure for home health aides.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Madeline R Sterling, MD, MPH, MS, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): August 17, 2024
• Study Completion (Actual): August 17, 2024

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: home health aides; home health care; home care agency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 19-08020553; K23HL150160-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No