Heart Failure Clinical Trial

Improving Heart Failure Care in Minority Communities

Summary

For congestive heart failure (CHF) patients with systolic dysfunction, a randomized controlled trial compared nurse-based disease management to address problems in patient and clinician management with usual care for effects on hospitalization and functioning among ethnically-diverse patients in ambulatory practices.

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Full Description

Congestive heart failure (CHF) disproportionately afflicts Black and elderly people, and is a leading cause of hospitalization > 65 years. Although effective therapies can improve functioning and survival in patients with systolic dysfunction, many may not be receiving the full benefit of existing knowledge, including counseling on self-management and appropriate doses of medications. Patients play a critical role in managing a chronic condition such as CHF, but may not have the skills to do so. Clinicians may not provide counseling or medications consistent with evidence-based guidelines.

Systematic reviews of clinical-behavior change have suggested that interventions targeted to specific problems are more likely to be successful. Based on shortfalls identified in patient self-management and clinical care in Harlem, a predominately non-white area in northern Manhattan, we tailored a nurse-management intervention to address the problems documented, and evaluated its effectiveness in a randomized controlled trial. This trial among primarily-minority patients addresses important gaps in this literature: the study targeted problems documented among CHF patients in Harlem, enrolled patients from ambulatory practices, randomly assigned patients between nurse-management and usual care, and evaluated their subsequent health-related outcomes. Hypothesis: the nurse-management program would result in nurse patients' having fewer hospitalizations and reporting better functioning.

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Eligibility Criteria

Inclusion Criteria:

• adults >18 years,

systolic dysfunction documented on a cardiac test (echocardiography, radionuclide ventriculography, myocardial stress sestamibi/thallium testing, or left-heart catheterization),
English- or Spanish-speaking,
community-dwelling at enrollment, and
current patient in a general medicine, geriatrics, or cardiology clinic or office at a participating site.

Exclusion Criteria:

• medical conditions that prevented a patient's interacting with the nurse, including blindness, deafness, and cognitive impairment;

medical conditions that required individualized management that might differ from standard protocol, namely pregnancy, renal dialysis, and terminal illness; and
procedures that corrected systolic dysfunction, such as heart transplantation.

Study is for people with:

Heart Failure

Estimated Enrollment:

406

Study ID:

NCT00211874

Recruitment Status:

Completed

Sponsor:

Icahn School of Medicine at Mount Sinai

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There are 3 Locations for this study

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Mount Sinai School of Medicine
New York New York, 10029, United States
Metropolitan Hospital
New York New York, 10029, United States
North General Hospital
New York New York, 10035, United States
Harlem Hospital
New York New York, 10037, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

406

Study ID:

NCT00211874

Recruitment Status:

Completed

Sponsor:


Icahn School of Medicine at Mount Sinai

How clear is this clinincal trial information?

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