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The Effectiveness of Personalized Stroke Risk Communication (RiskCom)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178060
First Posted: August 9, 2010
Last Update Posted: August 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Durham VA Medical Center
  Purpose
The goal of this research is to improve communication to Veterans. The investigators want to improve how doctors and nurses talk to patients about the risk of heart attack and stroke. The investigators will give everyone in the study information about the risk for heart attack or stroke. The investigators will also provide information on how to reduce this risk. This information will be given in one of two ways. The investigators want to see which way of giving information works better for veterans. The investigators also want to assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the impact of personalized risk communication on medication adherence and blood pressure. The investigators plan to enroll approximately 100 veterans for this study. All veterans will be from the Durham VA Primary Care Clinics. The investigators will ask everyone to be in the study for 3 months.

Condition Intervention
Cardiovascular Disease Stroke Other: Personalized Heart Attack and Stroke Risk Other: Standard Education

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Evaluate impact on medication adherence [ Time Frame: 3-months ]
    Evaluate the impact of personalized risk communication on medication adherence at 3-months


Enrollment: 90
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Standard Education
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.

Detailed Description:

Background:

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.

Objectives:

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.

Methods:

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.

Status:

The study finished enrollment and all follow-up visits have been completed. The data from this project is being analyzed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in a Durham VA Primary Care Clinic for at least one year
  • Age ≥ 55 years old
  • Diagnosis ICD 401.0, 401.1, or 401.9 on outpatient electronic encounter forms in the prior year
  • Received a prescription for hypertensive medication (ACE inhibitors, beta blockers, calcium channel blockers, diuretics, alpha1 blockers, and/or central alpha2 agonists) in the previous year
  • Inadequate BP control based on an average of prior 12-month clinic BP measurements
  • Have a baseline EKG within the last 5 years to evaluate the presence of left ventricular hypertrophy.

Exclusion Criteria:

  • Hospitalized at the DVAMC for a myocardial infarction (MI), coronary artery revascularization, or diagnosis of metastatic cancer in the past 6 months
  • Prior history of stroke
  • Active diagnosis of psychosis or dementia documented in medical record
  • Participating in another chronic disease self-management study
  • Resident of a nursing home
  • Does not have access to a telephone
  • Refusal to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Hayden Bosworth, PhD Durham VA Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hayden Bosworth, PhD/Associate Director HSR&D and Benjamin Powers, MD/Co-I, Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT01178060     History of Changes
Other Study ID Numbers: RRP 08-240
First Submitted: August 6, 2010
First Posted: August 9, 2010
Last Update Posted: August 23, 2010
Last Verified: August 2010

Keywords provided by Durham VA Medical Center:
Stroke
Risk
Communication
Cardiovascular Disease Knowledge
Improve Risk Communication

Additional relevant MeSH terms:
Stroke
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases