Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes (FIMDM_CVD)
|ClinicalTrials.gov Identifier: NCT01134458|
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : July 22, 2014
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 or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Peripheral Artery Disease Ischemic Stroke Diabetes||Behavioral: Web-Based Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|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|
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
Other Name: Health Dialog Cardiac Risk Calculator
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134458
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Hayden Bosworth, PhD||Duke University|