NCT00388622

Brief Summary

The aims of this randomized, clinical trial are to develop and test a multileveled pharmacy-based program to improve the care of patients with heart failure. Risk factors for deterioration of heart failure will be determined including poor adherence to medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
314

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Feb 2001

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

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

February 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2006

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 17, 2006

Completed
Last Updated

October 17, 2006

Status Verified

October 1, 2006

First QC Date

October 8, 2006

Last Update Submit

October 16, 2006

Conditions

Heart Failure

Keywords

Heart failureAdherenceCompliancePharmacyPharmacistHealth-related quality of lifeClinical exacerbationCosts

Outcome Measures

Primary Outcomes (3)

  • Medication adherence

  • Exacerbation of heart failure

  • Health-related quality of life

Secondary Outcomes (3)

  • Patient satisfaction

  • Health care utilization

  • Direct costs

Interventions

Pharmacist interventionBEHAVIORAL

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 50 and older
  • prescription for at least one cardiovascular medication for heart failure
  • plan to receive care and prescriptions at the study health care facility
  • ability to hear within the normal range of conversation
  • English speaking
  • willingness to obtain echocardiography

You may not qualify if:

  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill, School of Pharmacy, CB 7360

Chapel Hill, North Carolina, 27599-7360, United States

Location

Related Publications (5)

  • Noureldin M, Plake KS, Morrow DG, Tu W, Wu J, Murray MD. Effect of health literacy on drug adherence in patients with heart failure. Pharmacotherapy. 2012 Sep;32(9):819-26. doi: 10.1002/j.1875-9114.2012.01109.x. Epub 2012 Jun 28.

    PMID: 22744746DERIVED

  • Kim KM, Murray MD, Tu W, Robarge J, Ding Y, Brater DC, Flockhart DA. Pharmacogenetics and healthcare outcomes in patients with chronic heart failure. Eur J Clin Pharmacol. 2012 Nov;68(11):1483-91. doi: 10.1007/s00228-012-1280-z. Epub 2012 Apr 29.

    PMID: 22543981DERIVED

  • Murray MD, Ritchey ME, Wu J, Tu W. Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. Arch Intern Med. 2009 Apr 27;169(8):757-63. doi: 10.1001/archinternmed.2009.59.

    PMID: 19398687DERIVED

  • Murray MD, Tu W, Wu J, Morrow D, Smith F, Brater DC. Factors associated with exacerbation of heart failure include treatment adherence and health literacy skills. Clin Pharmacol Ther. 2009 Jun;85(6):651-8. doi: 10.1038/clpt.2009.7. Epub 2009 Mar 4.

    PMID: 19262464DERIVED

  • Murray MD, Young J, Hoke S, Tu W, Weiner M, Morrow D, Stroupe KT, Wu J, Clark D, Smith F, Gradus-Pizlo I, Weinberger M, Brater DC. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007 May 15;146(10):714-25. doi: 10.7326/0003-4819-146-10-200705150-00005.

    PMID: 17502632DERIVED

MeSH Terms

Conditions

Heart FailurePatient Compliance

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Michael D Murray, PharmD, MPH

    UNC-Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2006

First Posted

October 17, 2006

Study Start

February 1, 2001

Study Completion

November 1, 2004

Last Updated

October 17, 2006

Record last verified: 2006-10

Locations

US(1)