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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Failure Self Care Support
Usual heart failure care
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, self care, decision support, telemonitoring, navigator

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Heart Failure Self Care Support

Usual Heart Failure Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rehospitalization
Rehospitalization with primary diagnosis of heart failure

Secondary Outcome Measures

Full Information

First Posted
May 26, 2010
Last Updated
January 30, 2019
Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01141907
Brief Title
Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program
Official Title
Nurse-Led Heart Failure Care Transition Intervention for African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, self care, decision support, telemonitoring, navigator

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure Self Care Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Heart Failure Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Heart Failure Self Care Support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual heart failure care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rehospitalization
Description
Rehospitalization with primary diagnosis of heart failure
Time Frame
3 months post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl R Dennison, PhD
Organizational Affiliation
Johns Hopkins University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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

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