Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes - Full Text View

Purpose

The investigators propose an evaluation that will assess three important components of risk communication:

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
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.
evaluate how this feedback can be incorporated into clinical care by examining 3 month patient outcome and provider responses to the risk information.

Condition	Intervention
Cardiovascular Disease Peripheral Artery Disease Ischemic Stroke Diabetes	Behavioral: Web-Based Intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Exercise and Physical Fitness Healthy Living Peripheral Arterial Disease Quitting Smoking Smoking

Drug Information available for: Benzocaine Hydroxypropyl cellulose

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Cardiovascular Disease (CVD) Risk Knowledge Assessment [ Time Frame: Baseline and 3 month @ study end ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	150
Study Start Date:	December 2010
Estimated Study Completion Date:	February 2014
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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 Name: Health Dialog Cardiac Risk Calculator

Arms

Assigned Interventions

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

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 Name: Health Dialog Cardiac Risk Calculator

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134458

Locations

United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Hayden Bosworth, PhD

Duke University

More Information

No publications provided

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT01134458 History of Changes
Other Study ID Numbers:	Pro00024341, FIMDM Research Grant 0170-1
Study First Received:	May 28, 2010
Last Updated:	February 20, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

cardiovascular disease

Additional relevant MeSH terms:

Cardiovascular Diseases
Stroke
Peripheral Arterial Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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