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OpenTrials
Completed

NCT Number: NCT00211874

Improving Heart Failure Care in Minority Communities

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harlem Hospital, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nurse-management

Behavioral

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.

Other names: Nurse-based disease management

Primary outcomes

  1. Short Form 12 questionnaire

    Time frame: 12 months

    self-reported physical functioning as measured by the physical component score on the Short Form 12 questionnaire

Secondary outcomes

  1. Number of hospitalizations

    Time frame: 12 months

    number of hospitalizations in 12 month period

  2. Minnesota Living with Heart Failure Questionnaire

    Time frame: 12 months

    self-reported physical functioning as measured by the physical component score on the Minnesota Living with Heart Failure Questionnaire

  3. Number of deaths

    Time frame: 12 months

    deaths measured by the reporting of death by patient family or recording in the National Death Index

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2000
Primary completion
2002
Study completion
2002
First posted
Sep 21, 2005
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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