MedDataX Logo

An Intervention to Reduce Prehospital Delay to Treatment in Acute Coronary Syndrome

NCT ID: NCT00734760

Last Updated: 2008-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2006-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Coronary Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

patient education acute coronary syndrome prehospital delay to treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

education

Intervention Type BEHAVIORAL

face-to-face education and counseling intervention

B

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

education

face-to-face education and counseling intervention

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

none applicable

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of California, San Francisco

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathleen A Dracup, DNSc

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18504332 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18507563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18022812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16699358 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20031889 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIH RO! NR05323

Identifier Type: -

Identifier Source: secondary_id

RO! NR05323

Identifier Type: -

Identifier Source: org_study_id