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Leveraging Home Health Aides to Improve Outcomes in Heart Failure

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ClinicalTrials.gov Identifier: NCT04239911
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : June 29, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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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 Visiting Nurse Service of New York's (VNSNY) 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).

Condition or disease Intervention/treatment Phase
Heart Failure Congestive Heart Failure Behavioral: mHealth app Behavioral: Virtual training course Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 104 home health aides will be recruited from VNSNY 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 (Outcomes Assessor)
Masking Description: Data analyst will be blinded to study arm.
Primary Purpose: Health Services Research
Official Title: Leveraging Home Health Aides to Improve Outcomes in Heart Failure: A Pilot Randomized Controlled Trial
Actual Study Start Date : May 16, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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: 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.

Behavioral: Virtual training course
Virtual training course on heart failure for home health aides.


Outcome Measures
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Primary Outcome Measures :
  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. Scores < 70 are considered poor or inadequate.


Secondary Outcome Measures :
  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.


Other Outcome Measures:
  1. Number of visits to the emergency department [ Time Frame: 90 days ]
    All-cause emergency department visits to any emergency department

  2. Number of readmissions to the hospital [ Time Frame: 90 days ]
    All-cause readmissions to any hospital


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Home health aide employed at VNSNY's 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239911


Contacts
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Contact: Madeline R Sterling, MD, MPH, MS 6469625029 mrs9012@med.cornell.edu

Locations
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United States, New York
Visiting Nurse Service of New York's Partners in Care Recruiting
New York, New York, United States, 10017
Contact: Margaret McDonald, MSW       margaret.mcdonald@vnsny.org   
Contact: Penny H Feldman, PhD    2126091530    pfeldman@vnsny.org   
Principal Investigator: Penny H Feldman, PhD         
Sponsors and Collaborators
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Madeline R Sterling, MD, MPH, MS Weill Medical College of Cornell University
More Information
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04239911    
Other Study ID Numbers: 19-08020553
K23HL150160-01 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
home health aides
home health care
home care agency
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases