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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cheryl R. Dennison, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01141907
First received: May 26, 2010
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: Navigator Team Intervention
Other: Usual heart failure care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nurse-Led Heart Failure Care Transition Intervention for African Americans

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Rehospitalization [ Time Frame: 3 months post enrollment ] [ Designated as safety issue: Yes ]
    Rehospitalization with primary diagnosis of heart failure


Secondary Outcome Measures:
  • Heart Failure Self Care [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]
    Heart Failure Self Care Index

  • Care Transition [ Time Frame: 1 month post-enrollment ] [ Designated as safety issue: No ]
    Care Transition Measure

  • Emergency Room Visits [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: Yes ]
    Frequesncy of Emergency Room Visits

  • Heart Failure-Related Quality of Life [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]
    Minnesota Living with Heart Failure Questionnaire


Enrollment: 25
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heart Failure Self Care Support Behavioral: Navigator Team Intervention
The intervention is aimed at controlling heart failure (HF) and preventing exacerbations and hospitalizations by improving self management behaviors with the support of the Home Automated Telemonitoring (HAT) system. The intervention will be 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 will be initiated during the index hospitalization or as soon as possible after randomization. The RN-CHN team will collaborate with the participants, their caregivers, and their usual source of HF care. Intervention strategies include tracking of weight and HF symptoms to provide automated feedback regarding self management and plan of care, enhancing medication and symptom self management, promoting HF care follow up, and using a patient centered record to promote communication with providers.
Active Comparator: Usual Heart Failure Care Other: Usual heart failure care
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141907

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Cheryl R Dennison, PhD Johns Hopkins University School of Nursing
  More Information

No publications provided

Responsible Party: Cheryl R. Dennison, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01141907     History of Changes
Other Study ID Numbers: R21NR011056, R21NR011056
Study First Received: May 26, 2010
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
heart failure
self care
decision support
telemonitoring
navigator

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014