Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program
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|ClinicalTrials.gov Identifier: NCT01141907|
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : May 28, 2012
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 or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: Navigator Team Intervention Other: Usual heart failure care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Nurse-Led Heart Failure Care Transition Intervention for African Americans|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
|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.
- Rehospitalization [ Time Frame: 3 months post enrollment ]Rehospitalization with primary diagnosis of heart failure
- Heart Failure Self Care [ Time Frame: 3 months post-enrollment ]Heart Failure Self Care Index
- Care Transition [ Time Frame: 1 month post-enrollment ]Care Transition Measure
- Emergency Room Visits [ Time Frame: 3 months post-enrollment ]Frequesncy of Emergency Room Visits
- Heart Failure-Related Quality of Life [ Time Frame: 3 months post-enrollment ]Minnesota Living with Heart Failure Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141907
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Cheryl R Dennison, PhD||Johns Hopkins University School of Nursing|