NCT00536224

Brief Summary

The purpose of this study is to determine whether a brief counseling intervention initiated in the chest pain observation unit has a significant impact upon the health attitudes (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking) of emergency department patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

September 25, 2007

Last Update Submit

April 24, 2018

Conditions

Chest Pain

Keywords

Health promotionEmergency Medical ServicesRandomized controlled trialChest pain observation unitCardiovascular risk factors

Outcome Measures

Primary Outcomes (2)

  • Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)

    2- and 6-months

  • Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation)

    2- and 6-months

Study Arms (2)

2

ACTIVE COMPARATOR

Minimal counseling

Behavioral: Minimal counseling

1

EXPERIMENTAL

Full counseling

Behavioral: Full counseling

Interventions

Full counselingBEHAVIORAL

The health educator generated a computerized report for the patient that outlined his/her Framingham risk score, the goal for each cardiovascular risk factor based on national guidelines, and recommended actions for achieving each goal. Based on the Ask-Advise-Assess-Assist-Arrange follow-up (5A's) framework for behavior change, counseling for specific risk-related behaviors (diet, physical activity, and smoking) was provided by a cardiovascular rehabilitation health educator in the emergency department and during telephone follow-up (2 sessions over 6 weeks). Patients also received a general informational handout on self-management of cardiovascular risk factors (AHA Brochure "Controlling your risk factors"). A full report was also be sent to the patient's primary care physician (if any) at the conclusion of counseling.

1
Minimal counselingBEHAVIORAL

Patients assigned to the minimal counseling intervention received brief counseling (\<5 minutes) on the benefits of changing lifestyle and a handout with general information on self-management of cardiovascular risk factors. Patients assigned to minimal intervention also received an AHA brochure ("Controlling your risk factors") with general information on management of cardiovascular risk factors. At the end of 6-month follow-up, patients received a computerized report that outlined their Framingham risk score, the goal for each cardiovascular risk factor based on national guidelines, and recommended actions for achieving each goal.

2

Eligibility Criteria

Age30 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least one modifiable cardiovascular risk factor (smoking, hyperlipidemia, hypertension, diabetes mellitus, obesity)

You may not qualify if:

  • Patients who "rule-in" for myocardial ischemia at initial testing
  • Terminally ill (expected to survive less than 3 months)
  • Unavailable for 6-month follow-up
  • Cannot be contacted by telephone
  • Institutionalized persons (prisoners, nursing home residents)
  • Unable to provide informed consent (impaired mental status, unable to speak English)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

  • Katz DA, Graber M, Birrer E, Lounsbury P, Baldwin A, Hillis SL, Christensen AJ. Health beliefs toward cardiovascular risk reduction in patients admitted to chest pain observation units. Acad Emerg Med. 2009 May;16(5):379-87. doi: 10.1111/j.1553-2712.2009.00383.x. Epub 2009 Mar 16.

    PMID: 19302365BACKGROUND

  • Katz DA, Graber M, Lounsbury P, Vander Weg MW, Phillips EK, Clair C, Horwitz PA, Cai X, Christensen AJ. Multiple Risk Factor Counseling to Promote Heart-healthy Lifestyles in the Chest Pain Observation Unit: Pilot Randomized Controlled Trial. Acad Emerg Med. 2017 Aug;24(8):968-982. doi: 10.1111/acem.13231. Epub 2017 Jul 29.

    PMID: 28748625RESULT

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David A Katz, MD, MSc

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 27, 2007

Study Start

September 1, 2007

Primary Completion

July 1, 2009

Study Completion

January 1, 2017

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

US(1)