The Effectiveness of Personalized Stroke Risk Communication (RiskCom)
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|ClinicalTrials.gov Identifier: NCT01178060|
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : August 23, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Stroke||Other: Personalized Heart Attack and Stroke Risk Other: Standard Education||Not Applicable|
In 2005, over 17,000 patients were treated for stroke within the VA with a cost of almost $315 million. Prevention of stroke through reduction of established risk factors is an essential part of the VA Stroke QUERI strategic plan for the VA. In spite of this, in the Veterans Affairs, only 13% of patients with known CVD achieve target BP and cholesterol control. Combining risk factors into a composite measure of risk offers a better global assessment of individual risk and is recommended by the American Heart Association and American Stroke Association for prioritizing interventions. This practice is rarely done in routine clinical practice and its use as a tool to motivate patient behavior has not been tested. Current evidence from VA patients suggests that patients with hypertension do not adequately translate their risk factors into an accurate estimation of stroke risk. Improving the accuracy of stroke risk perceptions may be particularly important in motivating risk reduction in patients.
The objectives of this study are to: 1.) Assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors. 2.) Evaluate the impact of personalized risk communication on medication adherence and blood pressure. 3.) Explore the feasibility and obtain sample size estimates for a larger, investigator initiative research (IIR) application testing this tool.
A two-group randomized controlled trial testing a personalized risk communication intervention compared to an education-only control group was conducted. Eighty-nine patients were randomized and followed for 3months. Both groups received written and verbal patient education on stroke risk factors and prevention. Patients in the intervention arm also received personalized risk communication based on the Framingham stroke and coronary heart disease risk scores. A verbal and graphic presentation of their personal risk, risk relative to an age matched cohort, and their optimal or target risk based on optimal risk factor modification was presented. Outcomes measured immediately following the intervention and at 3months included: risk perception and worry; risk factor knowledge; decision preference and conflict; medication adherence; health behaviors; and blood pressure.
The study finished enrollment and all follow-up visits have been completed. The data from this project is being analyzed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Effectiveness of Personalized Stroke Risk Communication - A Pilot Randomized Controlled Trial|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Active Comparator: Personalized Risk Information
Patients received personalized stroke and heart attack risk assessment information.
Other: Personalized Heart Attack and Stroke Risk
Personalized assessment of heart attack and stroke risk based on 10yr predictors with individual risk factors.
Patients received general risk information on heart attack and stroke.
Other: Standard Education
Patients received a general handout describing risk factors for heart attack and stroke.
- Impact of personalized risk information [ Time Frame: baseline ]Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.
- Impact of personalized risk information [ Time Frame: 3 month ]Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.
- Evaluate impact on medication adherence [ Time Frame: 3-months ]Evaluate the impact of personalized risk communication on medication adherence at 3-months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178060
|United States, North Carolina|
|Durham VA Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Hayden Bosworth, PhD||Durham VA Medical Center|