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Sponsors and Collaborators: |
Mount Sinai School of Medicine Agency for Healthcare Research and Quality (AHRQ) |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00211874 |
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.
Condition | Intervention |
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Congestive Heart Failure (CHF) Systolic Dysfunction |
Behavioral: Nurse-based disease management |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Improving Heart Failure Care in Minority Communities |
Estimated Enrollment: | 406 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | October 2003 |
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. We hypothesized that the nurse-management program would result in nurse patients’ having fewer hospitalizations and reporting better functioning.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• adults >18 years,
Exclusion Criteria:
• medical conditions that prevented a patient’s interacting with the nurse, including blindness, deafness, and cognitive impairment;
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029-6574 | |
Harlem Hospital | |
New York, New York, United States, 10037 | |
Metropolitan Hospital | |
New York, New York, United States, 10029 | |
North General Hospital | |
New York, New York, United States, 10035 |
Principal Investigator: | Jane Sisk, Ph.D. | Mount Sinai School of Medicine |
Study ID Numbers: | AHRQ R01 HS10402-01, 99-0347 |
Study First Received: | September 14, 2005 |
Last Updated: | September 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00211874 |
Health Authority: | United States: Institutional Review Board |
Congestive heart failure nurse management effectiveness trial |
quality improvement minority communities disease management |
Heart Failure Heart Diseases |
Cardiovascular Diseases |