Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

Not Applicable

Completed

• Conditions: Ischemic Stroke; Diabetes; Cardiovascular Disease; Peripheral Artery Disease
• Interventions: Behavioral: Web-Based Intervention

• Registration Number: NCT01134458
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Study Start: 2010-12
• Primary Completion: 2011-11
• Study Completion: 2014-02
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-18
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• cardiovascular disease (CVD)
• CVD risk equivalent (peripheral arterial disease, history of ischemic stroke, or diabetes)

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Exclusion Criteria

• metastatic cancer,
• dementia,
• active psychosis
• end-stage renal disease
• no access to computer with Internet

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based Intervention	Web-Based Intervention	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.

Primary Outcome Measures

Name	Time	Method
Cardiovascular Disease (CVD) Risk Knowledge Assessment	Baseline and 3 month @ study end	Trained personnel will obtain the patients' outcome values (i.e., weight, height, BP) at baseline and subsequent 3-month outcome using a digital sphygmomanometer and digital scale according to a standard protocol. The baseline interview includes demographics and an assessment of patients' health behavior, perceived risk, and interactions with their provider. At 3-month follow-up visit, patients will also undergo an in-person interview to determine changes in weight, smoking status, medication adherence, decisional conflict, knowledge.

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States