Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

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.

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Key information

Conditions

Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Ischemic Stroke Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-Based Intervention

Behavioral

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

Other names: Health Dialog Cardiac Risk Calculator

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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: FIMDM_CVD

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2014
First posted: Jun 2, 2010
Registry last updated: Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed