Leveraging Home Health Aides to Improve Outcomes in Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04239911
• Other study ID #: 19-08020553
• Secondary ID: K23HL150160-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: June 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: October 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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.
• Virtual training course
Virtual training course on heart failure for home health aides.

Locations

Country	Name	City	State
United States	VNS Health Partners in Care	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of visits to the emergency department	All-cause emergency department visits to any emergency department	90 days
Other	Number of readmissions to the hospital	All-cause readmissions to any hospital	90 days
Primary	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)
Primary	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.	Baseline (0 days); at follow-up (90 days)
Secondary	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)
Secondary	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.	Baseline (0 days); at follow-up (90 days)