- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00536224
Chest Pain Observation Unit Risk Reduction Trial
Brief Intervention to Promote Cardiovascular Risk Reduction in Patients Admitted to Chest Pain Observation Units
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least one modifiable cardiovascular risk factor (smoking, hyperlipidemia, hypertension, diabetes mellitus, obesity)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Minimal counseling
|
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. |
Experimental: 1
Full counseling
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)
Time Frame: 2- and 6-months
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2- and 6-months
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Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation)
Time Frame: 2- and 6-months
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2- and 6-months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David A Katz, MD, MSc, University of Iowa
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200702770
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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