Leveraging Home Health Aides to Improve Outcomes in Heart Failure
Primary Purpose
Heart Failure, Congestive Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth app
Virtual training course
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure focused on measuring home health aides, home health care, home care agency
Eligibility 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.
Sites / Locations
- VNS Health Partners in CareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Enhanced usual care
Intervention arm
Arm Description
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
Outcomes
Primary Outcome Measures
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.
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. Scores < 70 are considered poor or inadequate.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04239911
First Posted
January 21, 2020
Last Updated
October 6, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04239911
Brief Title
Leveraging Home Health Aides to Improve Outcomes in Heart Failure
Official Title
Leveraging Home Health Aides to Improve Outcomes in Heart Failure: A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive Heart Failure
Keywords
home health aides, home health care, home care agency
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Data analyst will be blinded to study arm.
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enhanced usual care
Arm Type
Active Comparator
Arm Description
Home health aides in the enhanced usual care arm will receive a virtual heart failure training course.
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Home health aides in the intervention arm will receive a virtual heart failure training course and a communication-based messaging app.
Intervention Type
Behavioral
Intervention Name(s)
mHealth app
Intervention Description
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
Intervention Name(s)
Virtual training course
Intervention Description
Virtual training course on heart failure for home health aides.
Primary Outcome Measure Information:
Title
Change in Heart Failure Knowledge
Description
As measured by the Dutch Heart Failure Knowledge Scale, scores range from 0-15; higher scores indicate greater heart failure knowledge.
Time Frame
Baseline (0 days); at follow-up (90 days)
Title
Change in Heart Failure Caregiving Self-efficacy
Description
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.
Time Frame
Baseline (0 days); at follow-up (90 days)
Secondary Outcome Measure Information:
Title
Change in Job Satisfaction
Description
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.
Time Frame
Baseline (0 days); at follow-up (90 days)
Title
Change in Intention to Leave
Description
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.
Time Frame
Baseline (0 days); at follow-up (90 days)
Other Pre-specified Outcome Measures:
Title
Number of visits to the emergency department
Description
All-cause emergency department visits to any emergency department
Time Frame
90 days
Title
Number of readmissions to the hospital
Description
All-cause readmissions to any hospital
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madeline R Sterling, MD, MPH, MS
Phone
6469625029
Email
mrs9012@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeline R Sterling, MD, MPH, MS
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VNS Health Partners in Care
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret McDonald, MSW
Email
margaret.mcdonald@vnshealth.org
First Name & Middle Initial & Last Name & Degree
Penny H Feldman, PhD
Phone
2126091530
Email
pfeldman@vnshealth.org
First Name & Middle Initial & Last Name & Degree
Penny H Feldman, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Leveraging Home Health Aides to Improve Outcomes in Heart Failure
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