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Clinical Trials/NCT01134458
NCT01134458CompletedNot Applicable

Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

Duke University2 sites in 1 country98 target enrollmentStarted: December 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
98
Locations
2
Primary Endpoint
Cardiovascular Disease (CVD) Risk Knowledge Assessment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Cardiovascular Disease (CVD) Risk Knowledge Assessment

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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