Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes (FIMDM_CVD)

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. Identifier: NCT01134458
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : July 22, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Peripheral Artery Disease Ischemic Stroke Diabetes Behavioral: Web-Based Intervention Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes
Study Start Date : December 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
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.
Experimental: 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.
Behavioral: Web-Based Intervention
  1. Health Dialog Cardiac Risk Calculator
  2. Health Dialog's Living with Coronary Heart Disease
  3. Tailored intervention including health behavior modules such as smoking cessation, exercise, diet, and weight
Other Name: Health Dialog Cardiac Risk Calculator

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

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 identifier (NCT number): NCT01134458

United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Principal Investigator: Hayden Bosworth, PhD Duke University

Responsible Party: Duke University Identifier: NCT01134458     History of Changes
Other Study ID Numbers: Pro00024341
FIMDM Research Grant 0170-1 ( Other Grant/Funding Number: Foundation for Informed Medical Decision Making, Inc )
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Keywords provided by Duke University:
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Peripheral Vascular Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents