Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

Diabetes Clinical Trial

— FIMDM_CVD  

Official title:

Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134458
• Other study ID #: Pro00024341
• Secondary ID: FIMDM Research G
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: July 18, 2014
• Start date: December 2010
• Est. completion date: February 2014

Study information

• Verified date: July 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 2014
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Ischemic Stroke
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Disease (CVD) Risk Knowledge Assessment	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.	Baseline and 3 month @ study end	No