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Improving Heart Failure Care in Minority Communities

Improving Heart Failure Care in Minority Communities

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00211874
Enrollment
406
Registered
2005-09-21
Start date
2000-09-30
Completion date
2002-09-30
Last updated
2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure (CHF), Systolic Dysfunction

Keywords

Congestive heart failure, nurse management, effectiveness trial, quality improvement, minority communities, disease management

Brief 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.

Interventions

BEHAVIORALNurse-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.

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Short Form 12 questionnaire12 monthsself-reported physical functioning as measured by the physical component score on the Short Form 12 questionnaire

Secondary

MeasureTime frameDescription
Number of hospitalizations12 monthsnumber of hospitalizations in 12 month period
Minnesota Living with Heart Failure Questionnaire12 monthsself-reported physical functioning as measured by the physical component score on the Minnesota Living with Heart Failure Questionnaire
Number of deaths12 monthsdeaths measured by the reporting of death by patient family or recording in the National Death Index

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026