An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome (PROMOTION)

August 12, 2008 updated by: University of California, San Francisco

Reducing Prehospital Delay in Acute Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Delay to treatment from the onset acute coronary syndrome (ACS)continues to be a significant cause of morbidity and mortality. This study was conducted to evaluate a tailored education and counseling program designed for individuals at high risk for a future event. Study Hypothesis: The central hypothesis of this study was that a focused education and counseling intervention delivered by a nurse will decrease time of delay in seeking treatment for the signs and symptoms of AMI in patients already identified as having ischemic heart disease. Patients were randomized to receive a nurse-administered education and counseling intervention designed to promote early presentation for medical treatment in the face of cardiac symptoms or to usual instructions by their healthcare provider. Primary & Secondary Endpoints: The primary endpoint of this trial was prehospital delay time, i.e., time from onset of symptoms to arrival at the hospital. The secondary endpoints were: use of the emergency medical system; use of aspirin; healthcare resource utilization; and knowledge, attitudes and beliefs about heart disease.

Study Type

Interventional

Enrollment (Actual)

3522

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
face-to-face education and counseling intervention
Other Names:
  • none applicable
No Intervention: B
care-as-usual with data collection at the same time points as the experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time from ACS symptom onset to admission to emergency department
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
pre-hospital aspirin use
Time Frame: two years
two years
emergency medical system use
Time Frame: two years
two years
resource utilization
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Kathleen A Dracup, DNSc, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

August 14, 2008

Last Update Submitted That Met QC Criteria

August 12, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RO! NR05323
  • NIH RO! NR05323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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