NCT00211874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2000

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

September 14, 2005

Last Update Submit

October 9, 2015

Conditions

Congestive Heart Failure (CHF)Systolic Dysfunction

Keywords

Congestive heart failurenurse managementeffectiveness trialquality improvementminority communitiesdisease management

Outcome Measures

Primary Outcomes (1)

  • Short Form 12 questionnaire

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

    12 months

Secondary Outcomes (3)

  • Number of hospitalizations

    12 months

  • Minnesota Living with Heart Failure Questionnaire

    12 months

  • Number of deaths

    12 months

Study Arms (2)

Nurse-management

EXPERIMENTAL

nurse-led intervention focused on specific management problems

Behavioral: Nurse-management

Usual Care

NO INTERVENTION

Usual care as control group

Interventions

Nurse-managementBEHAVIORAL

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.

Also known as: Nurse-based disease management
Nurse-management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

Metropolitan Hospital

New York, New York, 10029, United States

Location

North General Hospital

New York, New York, 10035, United States

Location

Harlem Hospital

New York, New York, 10037, United States

Location

Related Publications (3)

  • Sisk JE, Hebert PL, Horowitz CR, McLaughlin MA, Wang JJ, Chassin MR. Effects of nurse management on the quality of heart failure care in minority communities: a randomized trial. Ann Intern Med. 2006 Aug 15;145(4):273-83. doi: 10.7326/0003-4819-145-4-200608150-00007.

    PMID: 16908918RESULT

  • Horowitz CR, Rein SB, Leventhal H. A story of maladies, misconceptions and mishaps: effective management of heart failure. Soc Sci Med. 2004 Feb;58(3):631-43. doi: 10.1016/s0277-9536(03)00232-6.

    PMID: 14652059RESULT

  • Pignone MP, DeWalt DA. Health literacy and heart failure care in minority communities. Ann Intern Med. 2007 Feb 20;146(4):312; author reply 312. doi: 10.7326/0003-4819-146-4-200702200-00014. No abstract available.

    PMID: 17310058RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jane Sisk, Ph.D.

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Paul Hebert, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

September 1, 2000

Primary Completion

September 1, 2002

Study Completion

September 1, 2002

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

US(4)