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Completed

NCT Number: NCT04239911

Leveraging Home Health Aides to Improve Outcomes in Heart Failure

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Congestive Heart Failure Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VNS Health Partners in Care

New York, 10017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Virtual training course

Behavioral

Virtual training course on heart failure for home health aides.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Job Satisfaction

    Time frame: Baseline (0 days); at follow-up (90 days)

    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.

  2. Change in Intention to Leave

    Time frame: Baseline (0 days); at follow-up (90 days)

    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.

Other outcomes

  1. Number of Visits to the Emergency Department

    Time frame: Baseline (0 days); at follow-up (90 days)

    All-cause emergency department visits to any emergency department

  2. Number of Readmissions to the Hospital

    Time frame: Baseline (0 days); at follow-up (90 days)

    All-cause readmissions to any hospital

  3. Change in Preventable 911 Calls

    Time frame: Baseline (0 days); at follow-up (90 days)

    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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Leveraging Home Health Aides to Improve Outcomes in Heart Failure: A Pilot Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2020
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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