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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

May 26, 2010
May 25, 2012
February 2010
June 2011   (final data collection date for primary outcome measure)
Rehospitalization [ Time Frame: 3 months post enrollment ] [ Designated as safety issue: Yes ]
Rehospitalization with primary diagnosis of heart failure
Same as current
Complete list of historical versions of study NCT01141907 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program
Nurse-Led Heart Failure Care Transition Intervention for African Americans

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Heart Failure
  • 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.
  • 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.
  • Experimental: Heart Failure Self Care Support
    Intervention: Behavioral: Navigator Team Intervention
  • Active Comparator: Usual Heart Failure Care
    Intervention: Other: Usual heart failure care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01141907
R21NR011056, R21NR011056
Yes
Cheryl R. Dennison, Johns Hopkins University
Johns Hopkins University
National Institute of Nursing Research (NINR)
Principal Investigator: Cheryl R Dennison, PhD Johns Hopkins University School of Nursing
Johns Hopkins University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP