NCT00734760

Brief Summary

This study was conducted to test whether a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of acute coronary syndrome (i.e., heart attack) in patients already identified as having ischemic heart disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,522

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2001

Longer than P75 for not_applicable

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
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
Last Updated

August 14, 2008

Status Verified

August 1, 2008

Enrollment Period

5.3 years

First QC Date

August 12, 2008

Last Update Submit

August 12, 2008

Conditions

Acute Coronary Syndrome

Keywords

patient educationacute coronary syndromeprehospital delay to treatment

Outcome Measures

Primary Outcomes (1)

  • time from ACS symptom onset to admission to emergency department

    two years

Secondary Outcomes (3)

  • pre-hospital aspirin use

    two years

  • emergency medical system use

    two years

  • resource utilization

    two years

Study Arms (2)

A

EXPERIMENTAL

a tailored, face-to-face education and counseling intervention with a nurse lasting approximately 45 minutes, followed by a telephonic reinforcement in 30 days

Behavioral: education

B

NO INTERVENTION

care-as-usual with data collection at the same time points as the experimental group

Interventions

educationBEHAVIORAL

face-to-face education and counseling intervention

Also known as: none applicable
A

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of ischemic heart disease, confirmed by their physician or medical record
  • lived independently (i.e., not in an institutional setting).

You may not qualify if:

  • complicating serious co-morbidity such as a psychiatric illness or untreated malignancy
  • neurological disorder with impaired cognition
  • inability to read or understand English.
  • major uncorrected hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Dracup K, McKinley S, Doering LV, Riegel B, Meischke H, Moser DK, Pelter M, Carlson B, Aitken L, Marshall A, Cross R, Paul SM. Acute coronary syndrome: what do patients know? Arch Intern Med. 2008 May 26;168(10):1049-54. doi: 10.1001/archinte.168.10.1049.

    PMID: 18504332BACKGROUND

  • Aitken LM, Pelter MM, Carlson B, Marshall AP, Cross R, McKinley S, Dracup K. Effective strategies for implementing a multicenter international clinical trial. J Nurs Scholarsh. 2008;40(2):101-8. doi: 10.1111/j.1547-5069.2008.00213.x.

    PMID: 18507563BACKGROUND

  • Riegel B, McKinley S, Moser DK, Meischke H, Doering L, Dracup K. Psychometric evaluation of the Acute Coronary Syndrome (ACS) Response Index. Res Nurs Health. 2007 Dec;30(6):584-94. doi: 10.1002/nur.20213.

    PMID: 18022812BACKGROUND

  • Dracup K, McKinley S, Riegel B, Mieschke H, Doering LV, Moser DK. A nursing intervention to reduce prehospital delay in acute coronary syndrome: a randomized clinical trial. J Cardiovasc Nurs. 2006 May-Jun;21(3):186-93. doi: 10.1097/00005082-200605000-00006.

    PMID: 16699358BACKGROUND

  • Dracup K, McKinley S, Riegel B, Moser DK, Meischke H, Doering LV, Davidson P, Paul SM, Baker H, Pelter M. A randomized clinical trial to reduce patient prehospital delay to treatment in acute coronary syndrome. Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):524-32. doi: 10.1161/CIRCOUTCOMES.109.852608. Epub 2009 Oct 6.

    PMID: 20031889DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Kathleen A Dracup, DNSc

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 14, 2008

Study Start

February 1, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

August 14, 2008

Record last verified: 2008-08