This trial is active, not recruiting.

Conditions cardiovascular disease, peripheral artery disease, ischemic stroke, diabetes
Treatment web-based intervention
Sponsor Duke University
Start date December 2010
End date November 2011
Trial size 150 participants
Trial identifier NCT01134458, FIMDM Research Grant 0170-1, Pro00024341


The investigators propose an evaluation that will assess three important components of risk communication:

1. provide patients with personalized risk communication using the risk calculator developed by FIMDM and health information taken from the Living with Coronary Artery Disease program

2. provide personalized tailored patient feedback to help initiate and maintain specific cardiovascular CVD-related behaviors(e.g., medication adherence, exercise, diet, smoking cessation) to reduce their risks.

3. evaluate how this feedback can be incorporated into clinical care by examining 3 month patient outcome and provider responses to the risk information.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
(No Intervention)
Receive primary care and management of CVD according to the discretion of their primary care provider. They will also receive generic educational information concerning CVD at baseline and at study end (at their request). We will collect outcomes at baseline and 3-months.
Given current risk assessment for CVD based on Health Dialog Cardiac Risk Calculator, recommendations for behavior change, and Health Dialog's Living with Coronary Heart Disease. Can change initial patient risk information provided by the Risk Calculator during the initial visit, noting what they are will work on during the study. Sent monthly email reminders to log onto the system to choose that months' behavioral modules. Given a choice of at least 2 health behavior modules per month (smoking cessation, exercise, diet, and weight) to improve their CVD risk. Information on risk, CVD knowledge, medication management and side effects will be provided to all participants. It will also provide tailored information to help the individual initiate and maintain these behaviors.
web-based intervention Health Dialog Cardiac Risk Calculator
Health Dialog Cardiac Risk Calculator Health Dialog's Living with Coronary Heart Disease Tailored intervention including health behavior modules such as smoking cessation, exercise, diet, and weight

Primary Outcomes

Cardiovascular Disease (CVD) Risk Knowledge Assessment
time frame: Baseline and 3 month @ study end

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - cardiovascular disease (CVD) - CVD risk equivalent (peripheral arterial disease, history of ischemic stroke, or diabetes) Exclusion Criteria: - metastatic cancer, - dementia, - active psychosis - end-stage renal disease - no access to computer with Internet

Additional Information

Official title Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes
Principal investigator Hayden Bosworth, PhD
Description Patients at high risk for CVD events frequently underestimate their risk. Programs to improve CVD outcomes have largely focused on single risk factors and do not contextualize the information with a patient's global risk. An easy, accessible strategy to address global CVD risk based on personalized risk communication feedback with assistance with initiating and maintaining health behaviors has several advantages, but has not formally been tested. A patient's perceived risk of stroke or heart attack is an important factor in understanding motivation for risk reducing behaviors. Lower perceived risk has been associated with poorer adherence to recommended health behaviors. Additionally, a person's beliefs about his or her risk for a disease increased the likelihood of a more informed and activated patient, and figures prominently in models of health behavior (e.g., Health Belief Model). People tend to underestimate their own risk; Therefore providing accurate risk communication has the potential to activate patients to initiate and maintain behavior changes.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Duke University.