NCT00211874

Improving Heart Failure Care in Minority Communities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Congestive Heart Failure (CHF)
• Systolic Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	Nurse-management	bilingual nurses counseled patients on diet, medication adherence, and self-management of symptoms through an initial visit and regularly scheduled follow-up telephone calls and facilitated evidence-based changes to medications in discussions with patients' clinicians.

Timeline

• Start date: 2000-09-01
• Primary completion: 2002-09-01
• Completion: 2002-09-01
• First posted: 2005-09-21
• Last updated: 2015-10-12

Locations

4 sites across 1 country: United States