Chest Pain Observation Unit Risk Reduction Trial
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Brief Intervention to Promote Cardiovascular Risk Reduction in Patients Admitted to Chest Pain Observation Units|
- Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking) [ Time Frame: 2- and 6-months ]
- Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation) [ Time Frame: 2- and 6-months ]
|Study Start Date:||September 2007|
|Study Completion Date:||January 2017|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 2
Behavioral: 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.
Behavioral: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536224
|United States, Iowa|
|University of Iowa Hospital|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||David A Katz, MD, MSc||University of Iowa|