Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

NCT ID: NCT01134458

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-02-28

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.

Conditions

Cardiovascular Disease; Peripheral Artery Disease; Ischemic Stroke; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Web-Based Intervention

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Health Dialog Cardiac Risk Calculator

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hayden Bosworth, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

FIMDM Research Grant 0170-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00024341

Identifier Type: -

Identifier Source: org_study_id