Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program

NCT01141907 | Completed Results DMC

• 1 other identifier: R21NR011056
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic proportions. Annual rates of new and recurrent HF events including hospitalization and mortality are higher among African Americans. In this study, the investigators are testing an interdisciplinary model for heart failure care, with focus on enhancing self management and use of telehealth, which has significant potential to improve self management and outcomes. The main purpose of this study is to learn how to help African Americans with heart failure care for themselves at home. We hope to find out if a team including a nurse and community health navigator using a computer telehealth device can help people with heart failure stay healthier. The team will help people with heart failure to manage their medication, monitor their symptoms and weigh themselves every day after they leave the hospital. The team will also help people with heart failure learn to solve problems that may keep them from following their treatment plan.

Conditions

Heart Failure

Keywords

heart failure; self care; decision support; telemonitoring; navigator

Outcome Measures

Primary Outcomes (1)

• Rehospitalization

  Rehospitalization with primary diagnosis of heart failure

  3 months post enrollment

Study Arms (2)

Heart Failure Self Care Support

EXPERIMENTAL

The goal of the Heart Failure Self Care Support Intervention (Navigator Program), delivered by a nurse and community health navigator team over 3 months post discharge from the index hospitalization, was to improve care transitions by providing patients with tools and support that promote knowledge and skills for HF self care as they transition from hospital to home. The multifaceted Navigator Intervention included the following intervention components: HF home automated telemonitoring support, medication and symptom self management, patient-centered record, HF care follow up, and activation of key supporter.

Behavioral: Heart Failure Self Care Support

Usual Heart Failure Care

ACTIVE COMPARATOR

Usual care for HF patients included the following: 1) Referral to HF clinic if the patient has no usual source of HF outpatient care, 2) HF patient education by HF care coordinator (advanced practice nurse), and 3) HF self care guide. All participants were treated by their usual source of HF care in the usual manner.

Other: Usual heart failure care

Interventions

Heart Failure Self Care Support BEHAVIORAL

The intervention is aimed at preventing HF exacerbations and hospitalizations by improving self management with the support of the Home Automated Telemonitoring (HAT) system. The intervention was delivered by a RN-community health navigator (CHN) team over three months to HF patients and their caregivers in their home and via telephone and HAT system. The intervention was initiated during the index hospitalization. The RN-CHN team collaborated with participants, caregivers, and their usual source of HF care. Intervention strategies included tracking of weight and HF symptoms to provide feedback regarding self management and plan of care, enhancing medication and symptom self management, promoting HF care follow up, and promoting communication with providers.

Heart Failure Self Care Support

Usual heart failure care OTHER

Participants assigned to usual care are treated by their usual source of HF care in the usual manner and in accordance with the American College of Cardiology/American Heart Association Guidelines for the management of HF. Usual care for HF patients admitted to Johns Hopkins Hospital also includes the following: 1) Referral to HF clinic if the patient has no usual source of care and 2) HF patient education booklet.

Usual Heart Failure Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hospitalized with admitting diagnosis of heart failure in prior 8 weeks
• self-identified as African American
• community-dwelling (i.e., not in a long-term care facility)
• residence within a predefined radius in Baltimore City
• working telephone in their home
• provide signed informed consent

You may not qualify if:

• cannot speak or understand English
• severe renal insufficiency requiring dialysis
• acute myocardial infarction within preceding 30 days
• receiving home care services for HF post discharge
• legally blind or have major hearing loss
• screen positive for cognitive impairment on the Mini-cog at baseline
• unable to stand independently on a weight scale (limited ability to participate in HAT system)
• weigh more than 325 pounds (exceed scale capacity)
• serious or terminal condition such as psychosis or cancer (actively receiving chemo or radiation)
• pregnant

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Cheryl Dennison
• Organization: Johns Hopkins University

cdennis4@jhu.edu

443-287-4174

Study Officials

• Cheryl R Dennison, PhD

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: June 11, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-01

Locations

US (1)